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Evaluation of a smartphone application for self-care performance of patients with chronic hepatitis B: A randomized controlled trial
Evaluation of a Smartphone Application for Self-Care Performance of Patients with Chronic Hepatitis B: A Randomized Controlled Trial Jae Hee Jeon RN, PhD PII: DOI: Reference:
S0897-1897(16)30088-X doi: 10.1016/j.apnr.2016.07.011 YAPNR 50819
To appear in:
Applied Nursing Research
Received date: Revised date: Accepted date:
18 May 2016 15 July 2016 26 July 2016
Please cite this article as: Jeon, J.H., Evaluation of a Smartphone Application for SelfCare Performance of Patients with Chronic Hepatitis B: A Randomized Controlled Trial, Applied Nursing Research (2016), doi: 10.1016/j.apnr.2016.07.011
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Evaluation of a Smartphone Application for Self-Care Performance of Patients with Chronic Hepatitis B: A Randomized Controlled Trial
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Jae Hee Jeon, RN, PhD
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Correspondence to: Jae Hee Jeon, RN, PhD
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Associate Professor
Department of Nursing, Semyung University, 65 Semyung-ro, Jecheon, Chungbuk 390-711, Korea Tel: +82-43-649-1356 Fax: +82-43-649-1785
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Email: [email protected]
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Evaluation of a Smartphone Application for Self-Care Performance of Patients with Chronic 1
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Hepatitis B: A Randomized Controlled Trial
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Abstract
Aim: To verify the usefulness of a smartphone application (App) for facilitating self-care in patients with
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chronic hepatitis B (CHB).
Background: CHB is a global health problem, and patients with CHB need to routinely perform self-care.
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Health-related smartphone apps could help users self-manage their disease. Methods: Fifty-three CHB patients were assessed in this randomized controlled before-and-after experimental study. The patients were randomly and equally assigned to groups that did (n=26) or did not (n=27) use the smartphone app for 12 weeks. The experimental and control groups were analyzed for differences in disease knowledge, self-efficacy, and self-care before and after use of the smartphone app.
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Results: After intervention, patients who used the app displayed significantly increased disease knowledge compared with the control group (P=.015). Self-efficacy and self-care also significantly
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increased in the experimental group (P=0.006 and 0.001, respectively).
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Conclusion: The smartphone app can be useful for increasing self-care in CHB patients.
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Keywords: Smartphone, Application, Hepatitis B, Self-Care
Abbreviations: App: application, CHB: chronic hepatitis B, CVI: content validity 2
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Introduction
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The number of patients with chronic hepatitis B (CHB) is estimated at 350–400 million
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worldwide (Tseng et al., 2012). Every year, around 1 million patients with CHB die from disease-related complications such as cirrhosis, liver failure, and hepatocellular carcinoma and approximately 70% of
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primary hepatocellular carcinomas are caused by CHB (Tseng et al., 2012). A nationwide assessment of the hepatitis B infection prevalence in Korea, diagnosed by a positive hepatitis B surface antigen test,
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revealed that approximately 2.5–3.1% of the population is infected with CHB (Statistics Korea, 2013). If not properly treated and efficiently managed, CHB infection can result in death through its many complications, indicating that CHB is a significant public health issue (Cuenca et al., 2014). Moreover, symptoms such as fatigue, body weakness, nausea, vomiting, loss of appetite, dyspepsia, abdominal discomfort, bleeding tendency, swelling, abdominal edema, and jaundice occur as CHB
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infection progresses (Korean Association for the Study of the Liver, 2011). In addition, CHB can cause psychosocial problems, such as anxiety and withdrawal from interpersonal relationships. Such physical,
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psychological, and socioeconomic problems will consistently affect the everyday activities and quality of
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life of patients with CHB (Che et al., 2013). Accordingly, patients with CHB need to manage the symptoms and prevent severe sequelae
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(Korean Association for the Study of the Liver, 2011). When a patient with CHB becomes ill, however, clinical symptoms are often not clearly manifested until liver damage has considerably progressed (Korean Association for the Study of the Liver, 2011). Furthermore, many patients do not take disease management seriously and miss regular follow-up appointments or fail to adhere to treatment, potentially due to a low level of disease awareness of the patients (Che et al., 2013). Thus, it is important for patients with CHB to not only undergo medical treatment but also perform self-care in order to promote their own health and well-being (Orem, 1985). Self-care is an extensive concept that includes activities involved in disease prevention, disease and injury treatment, chronic disease management, rehabilitation, and health promotion (Orem, 1985). Proper and active selfcare of patients with chronic health conditions positively affects prognosis (Clark et al., 2001). Previous reports have indicated that knowledge of a disease (Che et al., 2013) and self-efficacy (Yang, 2012) are the main factors that can improve self-care of these patients. 3
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However, previous studies have revealed low levels of disease knowledge in patients with CHB (Ha et al., 2013), which plays a role in the negligence of self-care in these patients, as well as in the
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transmission of hepatitis B virus (Soto-Salgado et al., 2011; Ha et al., 2013). In order for patients with
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CHB to effectively perform self-care, in this study, the model of self-regulation for control of chronic disease proposed by Clark et al. (2001) was used as the conceptual framework. This model suggests that
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effective self-care can be achieved through self-regulation using continuous interactive processes. By 2020, 6.1 billion people, or approximately 70% of the global population, are expected to use
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smartphones, and at least 50% of smartphone users will use health-related mobile apps (Miller et al., 2014). Approximately 80% of the Korean population currently uses smartphones (Ministry of Science, ICT and Future Planning). Therefore, smartphones could represent an effective tool for health-related interventions. Specifically, health-related smartphone apps could help users self-manage their disease (Miller et al., 2014). It can be hypothesized that patients with CHB who use a smartphone app focusing
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on self-care performance would improve their overall self-care performance (Miller et al., 2014). An app search in 2013, however, found 23 hepatitis-related apps in the Google Play and Apple App Stores. Of
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these, only five apps were specific to hepatitis B (Cuenca et al., 2014), and none were developed in
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Korea. Moreover, the utilization rate of the already developed hepatitis-related apps was low, likely owing to a lack of evidence-based knowledge and limited functionality. Accordingly, based on user
2015).
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demand, a smartphone app facilitating self-care for patients with CHB was recently developed (Jeon,
In this study, this smartphone app, used as a self-regulation strategy for patients with CHB to
perform self-care, is presented, and its effects and utility with respect to disease knowledge, self-efficacy, and self-care performance of patients with CHB are analyzed.
Materials and Methods Theoretical Basis This study is based on the conceptual framework model of self-regulation for control of chronic disease (Clark et al., 2001). Self-regulation is an interactive feedback in which decisions are made based on observations, followed by appropriate responses (Clark et al., 2001). A self-regulation model is a process in which the ultimate goal is achieved through self-regulation based on continuous interaction and 4
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feedback (Bandura, 1986). In other words, individuals can change their behavior to manage chronic disease by self-regulation as a result of continuous interaction and feedback via observations, judgments,
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and reactions (Clark et al., 2001).
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For patients with CHB, such a self-regulation model consists of intrapersonal and external factors, observations, judgments, reactions, a self-regulation strategy, and a purpose. The intrapersonal
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factors in this study are the knowledge of the disease and attitudes and beliefs about using a smartphone app for CHB self-care. The external factors are the healthcare services for health management provided
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through the smartphone app. Responses occurring during the interaction feedback of observations and judgments are defined as the outcome expectations and expected values of a resource. Accordingly, during the development of this smartphone app, the attitudes, beliefs, outcome expectations, and the expected value of the app were assessed and considered (Jeon, 2015). A self-regulation model strategy is a method that individuals use to control their current disease.
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Individuals establish a strategy based on observations, judgments, and reactions to intrapersonal or external factors and consequently utilize that strategy during the self-regulation process (Clark et al.,
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2001). In this study, the self-regulation strategy was used for the smartphone app for self-care, and the
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reaction thereof was considered the outcome measurement of such use (e.g. the app utilization rate). The conceptual framework of the study is shown in Figure 1. In a self-regulation model, the
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purpose is achieved through a positive feedback loop. The smartphone app, provided as an external factor for patients with CHB, helps the patients acquire disease knowledge and improve self-efficacy through self-regulation that occurs during continuous interaction and feedback of observations, judgments, and reactions in order to ultimately improve self-care performance.
Study Design and Participants This study was designed as a randomized controlled trial. Pre-tests, interventions, and post-tests were conducted between April 1 and August 20, 2015. The participants were outpatients treated in the Department of Gastroenterology of the university hospital where the author works, which has 800 inpatient beds and an online support group for patients with CHB with approximately 20,000 members. For inclusion in the study, participants had to understand the study objectives, voluntarily agree to participate, and sign a written consent form. The specific inclusion criteria were: (1) patients diagnosed 5
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with CHB by a physician and with positive hepatitis B surface antigen test results during the prior 6 months and no CHB comorbidity, such as cirrhosis, hepatocellular carcinoma, or liver failure; (2) patients
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aged between 19 and 60 years and capable of survey self-administration; (3) patients who were using an
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Android smartphone at the time; and (4) patients who understood the study objectives and provided written consent for study participation.
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The sample size was estimated in the following manner: the expected effect sizes of disease knowledge, self-efficacy, and self-care performance were calculated by using a program for patients with
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CHB based on previous studies by Yang (2012). In Yang’s study (2012), the estimated effect sizes were 2.00 for knowledge, 0.83 for self-efficacy, and 0.88 for self-care performance. Hence, with the assumption of a two-tailed test, an α of 0.05, power (1-β) of 0.80, and a large effect size of 0.8, the minimum required sample size per group was estimated to be 26 (Cohen, 1992). With an expected dropout rate of 20%, the required sample size was thus determined to be 31 per group, for a total of 62
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Ethical Considerations
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patients.
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This study was approved by the Institutional Review Board of the hospital where the author works (C2014188 (1385)), and conducted with permission of the chief of the hospital, the chief of the
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nursing department, and a liver specialist in the gastroenterology department. Additionally, permission was received from the manager of the online support group for patients with CHB. All study participants provided written consent for participation. The study data were stored in a locked area and will be destroyed 3 years post-study. For ethical purposes, the control group was provided with the same smartphone app as the one used by the experimental group after the study was complete, and all participants were offered a small payment for participating. Permission was also obtained from the original authors to use the previously developed instruments in the study.
Randomization Participants were assigned to experimental and control groups by a research assistant using a block
randomization
method
(http://www.r-bloggers.com/example-2014-2-block-randomization/)
(Kleinman, 2014). Specifically, group assignments were made so that 31 patients each were allocated to 6
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the experimental and control groups in the order of enrollment (Figure 2). The allocation was concealed
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from the participants until the end of the experiment.
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Intervention Smartphone App
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The smartphone app used consists of 8 screens: Self-Care, Disease Knowledge, Statistics, Record of Liver Lab Data, My Information, Alarms, Role Practices, and App Information. In the "Self-
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Care" menu, the user can check the daily progress by answering 8 questions regarding 6 topic areas (regular follow-up, medicine, meals, drinking, exercise, and body weight). The results can be viewed as daily, weekly, and monthly statistics. "Disease knowledge" delivers theoretical knowledge based on evidence, including anatomical information relevant to CHB, causes of the disease, pathological physiology, symptoms, infection pathways, diagnosis, treatment, everyday activities and diet habits, and
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vaccinations. "Record of Liver Lab Data" allows the user to track their liver function test results in a calendar. The results and trends in the changes in the results can be viewed on the "Statistics" screen. "My
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Information" displays the user's history related to liver disease, and through "Alarms", the user can set
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alarms as reminders to take medication, of regular follow-up appointments, and of self-care performance. “Role Practices” provides a message board and space for the community of registered app users. Finally,
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the “App Information” screen describes the app and also displays a list of references for "Disease Knowledge" (Jeon, 2015). Moreover, a manager app that was created separately from the hepatitis B self-care app was
designed to control some parts of the app from a server. A research assistant served as the app manager was responsible for providing the service. For example, the manager app could manage the "Role Practices" board within the hepatitis B self-care app and send group push messages to the registered users (Figure 3).
Experimental Procedure We recruited participants through postings in an outpatient clinic at a university hospital that serves patients with CHB and through online study announcements on a CHB support group site. Contact was made with individuals interested in voluntarily participating in the study. A member of the research 7
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team contacted each interested participant and explained the objectives and methods of the study, and received written consent from each patient. The participants were allocated to either the experimental or
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the control group upon enrollment and completed a pre-intervention paper survey. Patients assigned to the
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experimental group were provided with an apk file for installing the smartphone app and an instruction manual that explained how to use the app. The experimental group was instructed to immediately install
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and use the app. The manager app was installed on the research assistant's smartphone to enable group push messages to be sent once or twice a week. The control group was instructed to perform everyday
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activities and follow the treatment prescribed by the hospital, as usual. To evaluate the effect of the app, a post-intervention paper survey was administered to the participants after 12 weeks.
Measurements 1. Smartphone App Utilization Rate
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Some contents of the smartphone app, such as the data from the "Self-Care" menu, were scored or summarized in the main server of the app developer. Although the exact numbers that users input could
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not be viewed, the daily and monthly utilization of the "Self-Care" menu was analyzed.
2. Disease knowledge
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Disease knowledge is the most essential factor in the self-management of health (Orem, 1985). To assess the disease knowledge of patients with CHB, an instrument developed by Jeon and Kim (2015) was used; this instrument includes 5 items regarding the anatomical structure and functions of the liver, 10 items regarding the infection pathways, 4 items regarding pathological physiology, 5 items regarding symptoms, 6 items regarding diagnosis, 4 items regarding treatment, 9 items regarding everyday activities and diet habits, and 6 items regarding vaccinations, for a total of 49 items. Each item had three response options, "yes", "no", and "don't know". Correct answers were given a score of 1, and incorrect or "don't know" answers were given a score of 0. The total score ranged from 0 to 49, and a higher score indicated a higher level of disease knowledge. The Kuder-Richardson Formula 20, a measure for internal consistency reliability, was 0.877 in the study by Jeon and Kim (2015) and 0.849 in this study.
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3. Self-efficacy
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Self-efficacy is one's belief that he or she can successfully perform activities necessary to
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achieve a specific goal (Bandura, 1986). To measure self-efficacy, the 14-item instrument from Kang (2003) for cirrhosis patients, was modified in order to make the items suitable for the disease-related characteristics of the current participants. The modified instrument was reviewed by a total of 5 experts,
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including a nursing professor, 2 gastroenterologists, and 2 nurses more than 5 years’ experience working with patients with liver disease, to measure the content validity (CVI). The CVI values were 0.80 or
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higher for all 14 items. Of the 14 items, 3, 1, 2, 1, 3, and 4 were related to medical instructions and medication adherence, management of symptoms and complications, exercise and rest, diet management, health management and the prevention of infection transmission, and preferred foods and stress management, respectively. Each item was measured on a 5-point Likert scale where 5 indicated "I am
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very confident" and 1 indicated "I am not very confident." The total score ranged from 14 to 70, and a higher score meant a higher level of self-efficacy. The Cronbach’s alpha values for this instrument were
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4. Self-care performance
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0.845 in Kang’s study (2003) and 0.837 in this study.
Self-care performance includes the everyday activities an individual performs to maintain his or
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her health, life, integrated functioning, or well-being (Orem, 1985). To measure self-care performance, a 23-item instrument, which was developed by revising the 13-item instrument originally developed by Park (2002), was used. To measure CVI, the revised 23-item instrument was reviewed by the same 5 experts mentioned above. The CVI values were 0.80 or higher for all 23 items. The instrument included 4, 1, 4, 4, 6, and 4 items related to medical instructions and medication taking, management of symptoms and complications, exercise and rest, diet management, health management and the prevention of infection transmission, and preferred foods and stress management, respectively. The items were measured on a 5-point Likert scale where a score of 5 indicated "I am doing it very well" and 1 meant "I never do it". The total score ranged from 23 to 115, and a higher score meant a higher level of self-care performance. The Cronbach’s alpha values for this instrument were 0.850 in Park’s study (2002) and 0.876 in this study.
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Statistical Analysis Data were analyzed using SPSS 21.0 (SPSS Inc., Chicago, IL). For analysis of the participants'
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general characteristics, the frequencies, percentiles, means, and standard deviations were computed. Chi-
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squared and Fisher's exact tests were used to test the homogeneity between the experimental and control groups with respect to the general characteristics and pre-intervention dependent variables. Descriptive
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statistics were used to analyze the smartphone app utilization rate in the experimental group. To test the between-group differences in disease knowledge, self-efficacy, and self-care performance before and after
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the use of the smartphone app, t-tests were used after normality was confirmed by the KolmogorovSmirnov normality test. The significance level for all tests was set at 5%.
Results
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1. General Participant Characteristics and Homogeneity Testing
Data from 53 participants (experimental group: n=27; control group: n=26) were analyzed
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(Figure 2). In the homogeneity tests, there were no significant differences between the groups in any of the general participant characteristics, confirming homogeneity of the dependent variables between the
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groups (Table 1).
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2. Homogeneity Testing on Pre-intervention Dependent Variables As determined by t-tests, the experimental and control groups were not significantly different
with respect to any of the pre-intervention dependent variables, confirming between-group homogeneity (Table 2).
3. Smartphone App Utilization Rate The utilization rate of the "Self-Care" menu was examined 12 weeks after initiation of the experiment. The utilization rates of the experimental group were 69.3%, 74.6%, 74.6%, and 82.0% at weeks 3, 6, 9, and 12, respectively, with a mean monthly utilization rate of 75.1%.
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4. Testing Effects of the Smartphone App (Table 3)
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The mean disease knowledge score increased between pre-intervention and post-intervention
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for both the experimental (33.15 vs. 37.93 points; mean change: 4.78 points) and control groups (32.00, vs. 33.11 points; mean change: 1.11 points). However, the score change for the experimental group was significantly higher than that for the control group (t=2.530, p=.015).
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The self-efficacy score of the experimental group increased by 1.59 points, from 56.56 points pre-intervention to 58.15 points post-intervention. On the other hand, the control group score decreased
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by 0.73 points, from 58.15 points pre-intervention to 57.42 points post-intervention. The change in the self-efficacy score was significantly different between the groups (t=2.867, p=.006). The self-care performance score of the experimental group increased by 5.22 points, from 85.89 points pre-intervention to 91.11 points post-intervention, while the score of the control group decreased
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by 3.19 points, from 89.77 points pre-intervention to 86.58 points post-intervention. The change in the
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self-care performance score was significantly different between groups (t=3.597, p=.001).
Discussion
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The present study used a randomized controlled trial design to evaluate the effects and utility of a smartphone app developed to facilitate self-care for patients with CHB. The results showed that the
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disease knowledge, self-efficacy, and self-care performance increased significantly in the experimental group compared to in the control group, suggesting that the smartphone app was useful for patients with CHB performing self-care. The pre-intervention mean disease knowledge scores were 33.15 and 32.00 points (out of 49 points) for the experimental and control groups, respectively. The mean score reported by Jeon and Kim (2015), in which the same instrument was used, was 31.15 points, and the score in Yang’s study (2012) was 17.44 points out of a maximum score of 28 points, although the instrument used was not identical to that used herein and in the study by Jeon and Kim (2015). However, when all scores were converted to a 100-point scale, they were similar (experimental: 67 points, control: 65 points; Jeon and Kim: 63 points; and Yang: 62 points). Disease knowledge in various areas, including etiology, vaccination, prevention of infection transmission, and everyday activities, is necessary for patients with CHB to perform self-care
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(Jeon & Kim, 2015). Thus, these relatively low knowledge scores may indicate poor self-care performance. However, in the present study, there was a statistically significant difference in the change
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in knowledge scores between the control and experimental groups post-intervention, indicating that the
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smartphone app may be effective in partially improving the disease knowledge and thereby the self-care of the patients.
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Significant differences were also noted in the changes in the self-efficacy scores between the experimental and control groups. There are numerous ways to increase self-efficacy, including by past
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experiences of achievement, vicarious experience, verbal persuasion, and support from others (Bandura, 1986). In this study, a Role Practices board was used as one of the app menus to improve self-efficacy; this board is believed to have actively contributed to improved participant self-efficacy through understanding of other patients’ experiences of achievement. In addition, once or twice a week, the research assistant used the manager app to send encouraging messages to those registered with the self-care app. Thus, it can be
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speculated that verbal persuasion from specialists and knowledge gained through vicarious experiences contributed to the improvement of self-efficacy in self-care performance in the experimental group. In
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previous studies, the disease knowledge and self-efficacy of the subjects were found to relate to the
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hepatitis virus infection rate, with a high infection rate associated with poor disease knowledge and selfefficacy of the patients (Soto-Salgado et al., 2011; Ha et al., 2013; Kuwabara, & Ching, 2014). Therefore,
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improving the disease knowledge and self-efficacy is important to improve the self-care of CHB patients. There was also a significant difference in the self-care performance score between the
experimental and control groups in this study. The pre-intervention scores of self-care performance were 85.89 and 89.77 out of a maximum score of 115 points for the experimental and control groups, respectively. Using a similar instrument to measure self-care performance, Yang (2012) reported a score of 59.75 out of a maximum score of 75 points, which are in the range of 75–80 points when converted to a 100-point scale. In these two previous studies, as well as in the present study, many participants were recruited from a clinical setting, such as a hospital. Most of these CHB patients receive regular follow-up from the hospital, as well as information and education from the medical staff regarding the disease prognosis and management (Yang, 2012). Therefore, the level of self-care is expected to be relatively high. Previous studies have reported that the degree of self-care and management in patients with hepatitis B infection affects the chronicity of the disease (Mohamed et al., 2012; Nkonge et al., 2012), 12
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further confirming the importance of self-care. However, in Korea, only about 25% of patients with CHB are aware that they are infected, and less than 20% of those who are aware reportedly care for their health
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and consistently receive follow-up and disease management from a hospital (Korean Association for the
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Study of the Liver, 2011). Accordingly, a smartphone app that anyone can easily use may be an effective medium to improve self-care performance in patients with CHB. Indeed, in a variety of other diseases such
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as chronic heart disease, diabetes mellitus, obesity and stroke, smartphone apps have been reported to improve the self-care of the subjects (Miller et al., 2014; Jo & Park, 2016; Sureshkumar et al., 2016),
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supporting the results of the present study.
The smartphone app developed in this study had an effect similar to that reported in a previous study of a self-management program for patients with CHB (Yang, 2012). In that previous study, the experimental group, who underwent the self-management program, showed greater improvements in disease knowledge, self-efficacy, coping behavior, and self-management performance than the control
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group, and the effects persisted over time. However, a large proportion of patients with CHB are at an economically active age, and may not have time to attend a program outside of their home on a
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predetermined schedule (Che et al., 2013). Thus, since there are no specified time or location
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requirements, a smartphone app is expected to have a stronger effect, because it can effectively deliver an intervention to a high number of patients (Cuenca et al., 2014).
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As the number of patients with chronic diseases is rapidly increasing worldwide, demands for a healthcare system centered around hospital-provided disease management, prevention, and patientcustomized services are increasing (Sureshkumar et al., 2016). In particular, the u-Health Service is a healthcare service in a ubiquitous computing environment that enables patient-customized services by combining healthcare and information technology. For patients with chronic diseases, the u-Health Service should be based on medical services and guidelines provided by hospitals and aim to improve patient health through self-management (Miller et al., 2014). If the smartphone app developed in this study can be linked to hospitals and be used to provide patient-customized services, it would represent a cost-effective mechanism for improving the self-care performance of patients with CHB and could potentially improve their overall health. Evaluation and discussion about the continuity and interaction feedback of the self-regulation process is necessary. In a survey conducted during the analytic phase of the development of this 13
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smartphone app, positive values for attitudes, beliefs, outcome expectations, and expected values of a smartphone app for the target population were identified (Jeon, 2015). The outcome expectation with the
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highest response rate for use of the app was, "I am curious about how to manage CHB" (Jeon, 2015).
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Consistent with this expectation, the participant utilization rate of the "Self-Care" menu gradually increased over time. This behavior was also reflected in the analyses of the effects of the smartphone app
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in the present study. In the experimental group, the disease knowledge, self-efficacy, and self-care performance significantly increased from the pre-intervention levels, indicating that the use of the
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smartphone app, for as little as 12 weeks, positively affected the users through interactions with intrapersonal and external factors, and, to a certain degree, helped them achieve step-wise responses and purpose through continuous observations and judgments (Clark et al., 2001). However, managing a chronic disease requires both short-term and continuous self-management (Sureshkumar et al., 2016). Therefore, a long-term study is needed in the future to evaluate the interaction feedback and continuity in
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patients with CHB who use this smartphone app and to identify factors impeding the interaction feedback and continuity.
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There were some limitations to this study. The psychological aspects and quality of life of patients with
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CHB were not considered in the smartphone app. Patients with CHB commonly complain of fatigue, reduced work ability, depression, and anxiety, and these symptoms have negative impacts on their quality
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of life, as well as mental and physical well-being (Che et al., 2013). For patients with CHB, the quality of life is often negatively affected early in the disease course, not only because the patients may be withdrawn from interpersonal relationships due to anxiety accompanied with the possibility of transmitting the disease to others, but also because the disease could ultimately progress to cirrhosis or hepatocellular carcinoma, for which curative treatment approaches are limited (Park et al., 2003). Nonetheless, the medical providers focus mainly on the treatment of the symptoms, and often do not consider the psychological aspects and quality of life while treating the patients (Che et al., 2013). In addition, little research has been conducted on the quality of life of patients with CHB (Park et al., 2003). Hence, when the app used in this study is updated in the future, functions related to psychological aspects and quality of life should be added.
Conclusions 14
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Herein, it was confirmed that a recently developed smartphone app for patients with CHB had positive effects on self-care performance. The results of this randomized controlled trial demonstrated
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that the disease knowledge, self-efficacy, and self-care performance improved in the experimental group
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compared to in the control group, indicating the effectiveness of the app for CHB patients.
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Acknowledgments
This article is based on the first author’s doctoral dissertation from Chung-Ang University in Korea
commercial, or not-for-profit sectors.
Conflicts of interest
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None
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(unpublished). This research did not receive any specific grant from funding agencies in the public,
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Jeon, J. H., & Kim, K. H. (2015). Development of disease knowledge instrument for patients with chronic hepatitis B. Journal of Korean Data Analysis Society, 17(3), 1599–1617.
Jo, S., & Park, H. (2016). Development and Evaluation of a Smartphone Application for Managing Gestational Diabetes Mellitus. Healthcare Informatics Research, 22(1), 11–21, http://dx.doi.org/10.4258/hir.2016.22.1.11.
Kang, S. (2003). [Master’s thesis]. The relationships among self efficacy, practice of self care and quality of life in patients with liver cirrhosis. Gyeongsang National University, Jinju.
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Kleinman, K. (2014). Example 2014.2: Block randomization. http://www.r-bloggers.com/example-2014-
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Korean Association for the Study of the Liver. (2011). Chronic hepatitis B treatment guidelines. Korea, Seoul.
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Kuwabara, N., & Ching, M. S. L. (2014). A review of factors affecting vaccine preventable disease in Japan. Hawai'i Journal of Medicine & Public Health, 73(12), 376–381.
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Miller, A. S., Cafazzo, J. A., & Seto, E. (2014). A game plan: Gamification design principles in mHealth applications for chronic disease management. Health Informatics Journal, 22, 184–193, http://dx.doi.org/10.1177/1460458214537511.
Mohamed, R., Ng, C. J., Tong, W. T., Abidin, S. Z., Wong, L. P., & Low, W. Y. (2012). Knowledge, attitudes and practices among people with chronic hepatitis B attending a hepatology clinic in Malaysia: a
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cross sectional study. BMC Public Health, 12(1), 601, http://dx.doi.org/10.1186/1471-2458-12-601.
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Nkonge, N. A., Mayabi, O. A., Kithinji, J., & Magambo, K. J. (2012). Knowledge, attitude and practice of health-care waste management and associated health risks in the two teaching and referral hospitals in
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Kenya. Journal of Community Health, 37(6), 1172–1177, http://dx.doi.org/10.1007/s10900-012-9580-x.
Orem, D. E. (1985). A concept of self-care for the rehabilitation client. Rehabilitation Nursing, 10(3), 33–
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36, http://dx.doi.org/10.1002/j.2048-7940.1985.tb00428.x.
Park, M. J. (2002). [Master’s thesis]. Knowledge, health belief, and preventive health behavior on hepatitis in hepatitis B carriers. Yonsei University, Seoul.
Park, C. K., Park, S. Y., Kim, E. S., Park, J. H., Hyun, D. W., & Yun, Y. M. (2003). Assessment of quality of life and associated factors in patients with chronic viral liver disease. The Korean Journal of Hepatology, 9(3), 212–221.
Soto-Salgado, M., Suárez, E., Ortiz, A. P., Adrovet, S., Marrero, E., Meléndez, M., et al. (2011). Knowledge of viral hepatitis among Puerto Rican adults: Implications for prevention. Journal of Community Health, 36(4), 565–573, http://dx.doi.org/10.1007/s10900-010-9342-6.
Statistics Korea, Life Tables for Korea. Seoul. (2013) http://nso.go.kr/ Accessed 14.09.29. 17
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Statistics of wireless communications. Ministry of Science, ICT and Future Planning.
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http://www.msip.go.kr/web/msipContents/contents.do?mId=MTQ2/ Accessed 15.06.15.
Sureshkumar, K., Murthy, G. V. S., Natarajan, S., Naveen, C., Goenka, S., & Kuper, H. (2016). Evaluation of the feasibility and acceptability of the ‘Care for Stroke’ intervention in India, a smartphone-
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enabled, carer-supported, educational intervention for management of disability following stroke. BMJ Open, 6(2), e009243, http://dx.doi.org/10.1136/bmjopen-2015-009243.
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Tseng, T. C., Liu, C. J., Yang, H. C., Su, T. H., Wang, C. C., Chen, C. L, et al. (2012). High levels of hepatitis B surface antigen increase risk of hepatocellular carcinoma in patients with low HBV load. Gastroenterology, 142(5), 1140–1149, http://dx.doi.org/10.1053/j.gastro.2012.03.020.
Yang, J. H. (2012). Development and evaluation of a program to promote self management in patients with chronic hepatitis B. Journal of Korean Academy Fundamentals of Nursing, 42(2), 258–268,
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http://dx.doi.org/10.4040/jkan.2012.42.2.258.
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Table 1. Baseline Characteristics of the Experimental and Control Groups
(n=27) n (%)
(n=26) n (%)
Categories
Male
24 (88.9)
Female
3 (11.1)
20-39
15 (55.6)
≥40
12 (44.4)
17 (65.4)
39.44±10.15
44.69±9.57
21 (77.8)
23 (88.5)
Age (years)
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Mean ± SD
Married and living together Marital status Other Yes Working
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No ≤ High school Education level
≥ University
6 (22.2)
3 (11.5)
26 (96.3)
24 (92.3)
1 (3.7)
2 (7.7)
3 (11.1)
4 (15.3)
3 (11.1)
4 (15.4)
Moderate
20 (74.1)
18 (69.2)
Poor
4 (14.8)
4 (15.4)
Seoul/Gyeonggi/Incheon
10 (37.0)
12 (46.2)
Gangwon/Chungcheong
5 (18.5)
2 (7.7)
Jeolla/Gyeongsang
9 (33.3)
10 (38.5)
Jeju/Country other than Korea
3 (11.1)
2 (7.7)
≤10
4 (14.8)
5 (19.2)
11-20
17 (63.0)
12 (46.7)
≥21
6 (22.2)
9 (34.6)
Yes (once)
6 (22.2)
8 (30.8)
admission due to CHB
Yes (> 1 time)
1 (3.7)
1 (3.8)
No
20 (74.1)
17 (65.4)
Remembers last
Yes
23 (85.2)
20 (76.9)
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Good
Area of residence
(years)
Hospital
19
1.000
2.344
.126
1.072*
.467
0.395*
.610
1.795*
.719
0.347*
.911
1.729*
.701
1.581*
.493
1.922*
1.000
0.593*
.501
9 (34.6)
22 (84.6)
Duration of CHB
0.670*
2 (7.7)
24 (88.9)
Economic status
p
24 (92.3)
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Sex
χ2
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Control
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Characteristics
Experimental
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Experimental
Control
(n=27)
(n=26)
n (%)
n (%)
No
4 (14.8)
6 (23.1)
Other hepatitis
Yes
1 (3.7)
treatment besides HME
No
26 (96.3)
23 (88.5)
Once a month
4 (14.8)
4 (15.4)
Every three months
19 (70.4)
15 (57.7)
4 (14.8)
7 (26.9)
23 (85.2)
19 (73.1)
4 (14.8)
7 (26.9)
Characteristics
Categories
for HME
Every six months Treated with AVHD
Yes No
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Regular follow-up
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(GOT, GPT)
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blood test result
p
2.977*
.430
-0.438
.663
1.277*
.503
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liver
χ2
2 (7.7)
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*= Fisher’s exact test; SD = standard deviation; CHB = chronic hepatitis B; GOT = glutamic oxaloacetic transaminase; GPT = glutamic pyruvic transaminase; HME = hospital medical examination; AVHD = anti-viral hepatitis drugs.
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Table 2. Homogeneity of Dependent Variables Pre-intervention Control (n=26) M ± SD
Disease knowledge
33.15 ± 7.15
32.00 ± 8.58
Self-efficacy
56.56 ± 4.92
Self-care performance
85.89 ± 7.00
t
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Experimental (n=27) M ± SD
.598
58.15 ± 5.08
-1.142
.259
89.77 ± 8.96
-1.760
.084
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M ± SD = Mean ± Standard Deviation.
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p
0.530
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Variables
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Table 3. Comparison of Disease Knowledge, Self-Efficacy, and Self-Care Performance Pre- and PostIntervention Post-test
Difference
M ± SD
M ± SD
Experimental (n=27)
33.15 ± 7.15
37.93 ± 6.99
4.78 ± 4.23
Control (n=26)
32.00 ± 8.58
33.11 ± 8.62
1.11 ± 6.16
Experimental (n=27)
56.56 ± 4.92
58.15 ± 5.08
1.59 ± 2.80
Control (n=26)
58.15 ± 5.27
57.42 ± 4.44
-0.73 ± 3.09
Experimental (n=27)
85.89 ± 7.00
91.11 ± 8.27
5.22 ± 10.42
Control (n=26)
89.77 ± 8.96
Self-care performance
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M ± SD = Mean ± Standard Deviation.
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Self-efficacy
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knowledge
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Disease
Group
22
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Pre-test M ± SD
Variables
86.58 ± 7.06
-3.19 ± 5.92
t
p
2.530
.015
2.867
.006
3.597
.001
Figure 1. Study Conceptual Framework
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Figure 2. Participant CONSORT flow diagram
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(b)
(c)
(d)
(e)
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(a)
Figure 3. Intervention smartphone application screens for users: (a) Main screen; (b) Self-care screen; c) Knowledge of disease screen; (d) Lab data record screen; (e) Statistics screen.
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Highlights - Disease knowledge has a significant effect on the performance of self-care of chronic hepatitis B.
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- Self-efficacy has a significant effect on the performance of self-care of chronic hepatitis B.
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- Smartphone applications can help facilitate disease knowledge and self-care of chronic hepatitis B.
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S0897-1897(16)30088-X doi: 10.1016/j.apnr.2016.07.011 YAPNR 50819
To appear in:
Applied Nursing Research
Received date: Revised date: Accepted date:
18 May 2016 15 July 2016 26 July 2016
Please cite this article as: Jeon, J.H., Evaluation of a Smartphone Application for SelfCare Performance of Patients with Chronic Hepatitis B: A Randomized Controlled Trial, Applied Nursing Research (2016), doi: 10.1016/j.apnr.2016.07.011
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Evaluation of a Smartphone Application for Self-Care Performance of Patients with Chronic Hepatitis B: A Randomized Controlled Trial
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Jae Hee Jeon, RN, PhD
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Correspondence to: Jae Hee Jeon, RN, PhD
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Associate Professor
Department of Nursing, Semyung University, 65 Semyung-ro, Jecheon, Chungbuk 390-711, Korea Tel: +82-43-649-1356 Fax: +82-43-649-1785
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Email: [email protected]
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Evaluation of a Smartphone Application for Self-Care Performance of Patients with Chronic 1
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Hepatitis B: A Randomized Controlled Trial
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Abstract
Aim: To verify the usefulness of a smartphone application (App) for facilitating self-care in patients with
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chronic hepatitis B (CHB).
Background: CHB is a global health problem, and patients with CHB need to routinely perform self-care.
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Health-related smartphone apps could help users self-manage their disease. Methods: Fifty-three CHB patients were assessed in this randomized controlled before-and-after experimental study. The patients were randomly and equally assigned to groups that did (n=26) or did not (n=27) use the smartphone app for 12 weeks. The experimental and control groups were analyzed for differences in disease knowledge, self-efficacy, and self-care before and after use of the smartphone app.
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Results: After intervention, patients who used the app displayed significantly increased disease knowledge compared with the control group (P=.015). Self-efficacy and self-care also significantly
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increased in the experimental group (P=0.006 and 0.001, respectively).
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Conclusion: The smartphone app can be useful for increasing self-care in CHB patients.
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Keywords: Smartphone, Application, Hepatitis B, Self-Care
Abbreviations: App: application, CHB: chronic hepatitis B, CVI: content validity 2
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Introduction
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The number of patients with chronic hepatitis B (CHB) is estimated at 350–400 million
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worldwide (Tseng et al., 2012). Every year, around 1 million patients with CHB die from disease-related complications such as cirrhosis, liver failure, and hepatocellular carcinoma and approximately 70% of
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primary hepatocellular carcinomas are caused by CHB (Tseng et al., 2012). A nationwide assessment of the hepatitis B infection prevalence in Korea, diagnosed by a positive hepatitis B surface antigen test,
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revealed that approximately 2.5–3.1% of the population is infected with CHB (Statistics Korea, 2013). If not properly treated and efficiently managed, CHB infection can result in death through its many complications, indicating that CHB is a significant public health issue (Cuenca et al., 2014). Moreover, symptoms such as fatigue, body weakness, nausea, vomiting, loss of appetite, dyspepsia, abdominal discomfort, bleeding tendency, swelling, abdominal edema, and jaundice occur as CHB
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infection progresses (Korean Association for the Study of the Liver, 2011). In addition, CHB can cause psychosocial problems, such as anxiety and withdrawal from interpersonal relationships. Such physical,
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psychological, and socioeconomic problems will consistently affect the everyday activities and quality of
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life of patients with CHB (Che et al., 2013). Accordingly, patients with CHB need to manage the symptoms and prevent severe sequelae
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(Korean Association for the Study of the Liver, 2011). When a patient with CHB becomes ill, however, clinical symptoms are often not clearly manifested until liver damage has considerably progressed (Korean Association for the Study of the Liver, 2011). Furthermore, many patients do not take disease management seriously and miss regular follow-up appointments or fail to adhere to treatment, potentially due to a low level of disease awareness of the patients (Che et al., 2013). Thus, it is important for patients with CHB to not only undergo medical treatment but also perform self-care in order to promote their own health and well-being (Orem, 1985). Self-care is an extensive concept that includes activities involved in disease prevention, disease and injury treatment, chronic disease management, rehabilitation, and health promotion (Orem, 1985). Proper and active selfcare of patients with chronic health conditions positively affects prognosis (Clark et al., 2001). Previous reports have indicated that knowledge of a disease (Che et al., 2013) and self-efficacy (Yang, 2012) are the main factors that can improve self-care of these patients. 3
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However, previous studies have revealed low levels of disease knowledge in patients with CHB (Ha et al., 2013), which plays a role in the negligence of self-care in these patients, as well as in the
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transmission of hepatitis B virus (Soto-Salgado et al., 2011; Ha et al., 2013). In order for patients with
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CHB to effectively perform self-care, in this study, the model of self-regulation for control of chronic disease proposed by Clark et al. (2001) was used as the conceptual framework. This model suggests that
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effective self-care can be achieved through self-regulation using continuous interactive processes. By 2020, 6.1 billion people, or approximately 70% of the global population, are expected to use
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smartphones, and at least 50% of smartphone users will use health-related mobile apps (Miller et al., 2014). Approximately 80% of the Korean population currently uses smartphones (Ministry of Science, ICT and Future Planning). Therefore, smartphones could represent an effective tool for health-related interventions. Specifically, health-related smartphone apps could help users self-manage their disease (Miller et al., 2014). It can be hypothesized that patients with CHB who use a smartphone app focusing
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on self-care performance would improve their overall self-care performance (Miller et al., 2014). An app search in 2013, however, found 23 hepatitis-related apps in the Google Play and Apple App Stores. Of
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these, only five apps were specific to hepatitis B (Cuenca et al., 2014), and none were developed in
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Korea. Moreover, the utilization rate of the already developed hepatitis-related apps was low, likely owing to a lack of evidence-based knowledge and limited functionality. Accordingly, based on user
2015).
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demand, a smartphone app facilitating self-care for patients with CHB was recently developed (Jeon,
In this study, this smartphone app, used as a self-regulation strategy for patients with CHB to
perform self-care, is presented, and its effects and utility with respect to disease knowledge, self-efficacy, and self-care performance of patients with CHB are analyzed.
Materials and Methods Theoretical Basis This study is based on the conceptual framework model of self-regulation for control of chronic disease (Clark et al., 2001). Self-regulation is an interactive feedback in which decisions are made based on observations, followed by appropriate responses (Clark et al., 2001). A self-regulation model is a process in which the ultimate goal is achieved through self-regulation based on continuous interaction and 4
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feedback (Bandura, 1986). In other words, individuals can change their behavior to manage chronic disease by self-regulation as a result of continuous interaction and feedback via observations, judgments,
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and reactions (Clark et al., 2001).
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For patients with CHB, such a self-regulation model consists of intrapersonal and external factors, observations, judgments, reactions, a self-regulation strategy, and a purpose. The intrapersonal
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factors in this study are the knowledge of the disease and attitudes and beliefs about using a smartphone app for CHB self-care. The external factors are the healthcare services for health management provided
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through the smartphone app. Responses occurring during the interaction feedback of observations and judgments are defined as the outcome expectations and expected values of a resource. Accordingly, during the development of this smartphone app, the attitudes, beliefs, outcome expectations, and the expected value of the app were assessed and considered (Jeon, 2015). A self-regulation model strategy is a method that individuals use to control their current disease.
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Individuals establish a strategy based on observations, judgments, and reactions to intrapersonal or external factors and consequently utilize that strategy during the self-regulation process (Clark et al.,
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2001). In this study, the self-regulation strategy was used for the smartphone app for self-care, and the
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reaction thereof was considered the outcome measurement of such use (e.g. the app utilization rate). The conceptual framework of the study is shown in Figure 1. In a self-regulation model, the
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purpose is achieved through a positive feedback loop. The smartphone app, provided as an external factor for patients with CHB, helps the patients acquire disease knowledge and improve self-efficacy through self-regulation that occurs during continuous interaction and feedback of observations, judgments, and reactions in order to ultimately improve self-care performance.
Study Design and Participants This study was designed as a randomized controlled trial. Pre-tests, interventions, and post-tests were conducted between April 1 and August 20, 2015. The participants were outpatients treated in the Department of Gastroenterology of the university hospital where the author works, which has 800 inpatient beds and an online support group for patients with CHB with approximately 20,000 members. For inclusion in the study, participants had to understand the study objectives, voluntarily agree to participate, and sign a written consent form. The specific inclusion criteria were: (1) patients diagnosed 5
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with CHB by a physician and with positive hepatitis B surface antigen test results during the prior 6 months and no CHB comorbidity, such as cirrhosis, hepatocellular carcinoma, or liver failure; (2) patients
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aged between 19 and 60 years and capable of survey self-administration; (3) patients who were using an
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Android smartphone at the time; and (4) patients who understood the study objectives and provided written consent for study participation.
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The sample size was estimated in the following manner: the expected effect sizes of disease knowledge, self-efficacy, and self-care performance were calculated by using a program for patients with
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CHB based on previous studies by Yang (2012). In Yang’s study (2012), the estimated effect sizes were 2.00 for knowledge, 0.83 for self-efficacy, and 0.88 for self-care performance. Hence, with the assumption of a two-tailed test, an α of 0.05, power (1-β) of 0.80, and a large effect size of 0.8, the minimum required sample size per group was estimated to be 26 (Cohen, 1992). With an expected dropout rate of 20%, the required sample size was thus determined to be 31 per group, for a total of 62
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Ethical Considerations
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patients.
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This study was approved by the Institutional Review Board of the hospital where the author works (C2014188 (1385)), and conducted with permission of the chief of the hospital, the chief of the
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nursing department, and a liver specialist in the gastroenterology department. Additionally, permission was received from the manager of the online support group for patients with CHB. All study participants provided written consent for participation. The study data were stored in a locked area and will be destroyed 3 years post-study. For ethical purposes, the control group was provided with the same smartphone app as the one used by the experimental group after the study was complete, and all participants were offered a small payment for participating. Permission was also obtained from the original authors to use the previously developed instruments in the study.
Randomization Participants were assigned to experimental and control groups by a research assistant using a block
randomization
method
(http://www.r-bloggers.com/example-2014-2-block-randomization/)
(Kleinman, 2014). Specifically, group assignments were made so that 31 patients each were allocated to 6
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the experimental and control groups in the order of enrollment (Figure 2). The allocation was concealed
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from the participants until the end of the experiment.
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Intervention Smartphone App
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The smartphone app used consists of 8 screens: Self-Care, Disease Knowledge, Statistics, Record of Liver Lab Data, My Information, Alarms, Role Practices, and App Information. In the "Self-
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Care" menu, the user can check the daily progress by answering 8 questions regarding 6 topic areas (regular follow-up, medicine, meals, drinking, exercise, and body weight). The results can be viewed as daily, weekly, and monthly statistics. "Disease knowledge" delivers theoretical knowledge based on evidence, including anatomical information relevant to CHB, causes of the disease, pathological physiology, symptoms, infection pathways, diagnosis, treatment, everyday activities and diet habits, and
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vaccinations. "Record of Liver Lab Data" allows the user to track their liver function test results in a calendar. The results and trends in the changes in the results can be viewed on the "Statistics" screen. "My
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Information" displays the user's history related to liver disease, and through "Alarms", the user can set
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alarms as reminders to take medication, of regular follow-up appointments, and of self-care performance. “Role Practices” provides a message board and space for the community of registered app users. Finally,
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the “App Information” screen describes the app and also displays a list of references for "Disease Knowledge" (Jeon, 2015). Moreover, a manager app that was created separately from the hepatitis B self-care app was
designed to control some parts of the app from a server. A research assistant served as the app manager was responsible for providing the service. For example, the manager app could manage the "Role Practices" board within the hepatitis B self-care app and send group push messages to the registered users (Figure 3).
Experimental Procedure We recruited participants through postings in an outpatient clinic at a university hospital that serves patients with CHB and through online study announcements on a CHB support group site. Contact was made with individuals interested in voluntarily participating in the study. A member of the research 7
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team contacted each interested participant and explained the objectives and methods of the study, and received written consent from each patient. The participants were allocated to either the experimental or
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the control group upon enrollment and completed a pre-intervention paper survey. Patients assigned to the
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experimental group were provided with an apk file for installing the smartphone app and an instruction manual that explained how to use the app. The experimental group was instructed to immediately install
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and use the app. The manager app was installed on the research assistant's smartphone to enable group push messages to be sent once or twice a week. The control group was instructed to perform everyday
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activities and follow the treatment prescribed by the hospital, as usual. To evaluate the effect of the app, a post-intervention paper survey was administered to the participants after 12 weeks.
Measurements 1. Smartphone App Utilization Rate
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Some contents of the smartphone app, such as the data from the "Self-Care" menu, were scored or summarized in the main server of the app developer. Although the exact numbers that users input could
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not be viewed, the daily and monthly utilization of the "Self-Care" menu was analyzed.
2. Disease knowledge
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Disease knowledge is the most essential factor in the self-management of health (Orem, 1985). To assess the disease knowledge of patients with CHB, an instrument developed by Jeon and Kim (2015) was used; this instrument includes 5 items regarding the anatomical structure and functions of the liver, 10 items regarding the infection pathways, 4 items regarding pathological physiology, 5 items regarding symptoms, 6 items regarding diagnosis, 4 items regarding treatment, 9 items regarding everyday activities and diet habits, and 6 items regarding vaccinations, for a total of 49 items. Each item had three response options, "yes", "no", and "don't know". Correct answers were given a score of 1, and incorrect or "don't know" answers were given a score of 0. The total score ranged from 0 to 49, and a higher score indicated a higher level of disease knowledge. The Kuder-Richardson Formula 20, a measure for internal consistency reliability, was 0.877 in the study by Jeon and Kim (2015) and 0.849 in this study.
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3. Self-efficacy
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Self-efficacy is one's belief that he or she can successfully perform activities necessary to
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achieve a specific goal (Bandura, 1986). To measure self-efficacy, the 14-item instrument from Kang (2003) for cirrhosis patients, was modified in order to make the items suitable for the disease-related characteristics of the current participants. The modified instrument was reviewed by a total of 5 experts,
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including a nursing professor, 2 gastroenterologists, and 2 nurses more than 5 years’ experience working with patients with liver disease, to measure the content validity (CVI). The CVI values were 0.80 or
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higher for all 14 items. Of the 14 items, 3, 1, 2, 1, 3, and 4 were related to medical instructions and medication adherence, management of symptoms and complications, exercise and rest, diet management, health management and the prevention of infection transmission, and preferred foods and stress management, respectively. Each item was measured on a 5-point Likert scale where 5 indicated "I am
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very confident" and 1 indicated "I am not very confident." The total score ranged from 14 to 70, and a higher score meant a higher level of self-efficacy. The Cronbach’s alpha values for this instrument were
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4. Self-care performance
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0.845 in Kang’s study (2003) and 0.837 in this study.
Self-care performance includes the everyday activities an individual performs to maintain his or
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her health, life, integrated functioning, or well-being (Orem, 1985). To measure self-care performance, a 23-item instrument, which was developed by revising the 13-item instrument originally developed by Park (2002), was used. To measure CVI, the revised 23-item instrument was reviewed by the same 5 experts mentioned above. The CVI values were 0.80 or higher for all 23 items. The instrument included 4, 1, 4, 4, 6, and 4 items related to medical instructions and medication taking, management of symptoms and complications, exercise and rest, diet management, health management and the prevention of infection transmission, and preferred foods and stress management, respectively. The items were measured on a 5-point Likert scale where a score of 5 indicated "I am doing it very well" and 1 meant "I never do it". The total score ranged from 23 to 115, and a higher score meant a higher level of self-care performance. The Cronbach’s alpha values for this instrument were 0.850 in Park’s study (2002) and 0.876 in this study.
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Statistical Analysis Data were analyzed using SPSS 21.0 (SPSS Inc., Chicago, IL). For analysis of the participants'
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general characteristics, the frequencies, percentiles, means, and standard deviations were computed. Chi-
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squared and Fisher's exact tests were used to test the homogeneity between the experimental and control groups with respect to the general characteristics and pre-intervention dependent variables. Descriptive
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statistics were used to analyze the smartphone app utilization rate in the experimental group. To test the between-group differences in disease knowledge, self-efficacy, and self-care performance before and after
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the use of the smartphone app, t-tests were used after normality was confirmed by the KolmogorovSmirnov normality test. The significance level for all tests was set at 5%.
Results
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1. General Participant Characteristics and Homogeneity Testing
Data from 53 participants (experimental group: n=27; control group: n=26) were analyzed
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(Figure 2). In the homogeneity tests, there were no significant differences between the groups in any of the general participant characteristics, confirming homogeneity of the dependent variables between the
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groups (Table 1).
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2. Homogeneity Testing on Pre-intervention Dependent Variables As determined by t-tests, the experimental and control groups were not significantly different
with respect to any of the pre-intervention dependent variables, confirming between-group homogeneity (Table 2).
3. Smartphone App Utilization Rate The utilization rate of the "Self-Care" menu was examined 12 weeks after initiation of the experiment. The utilization rates of the experimental group were 69.3%, 74.6%, 74.6%, and 82.0% at weeks 3, 6, 9, and 12, respectively, with a mean monthly utilization rate of 75.1%.
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4. Testing Effects of the Smartphone App (Table 3)
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The mean disease knowledge score increased between pre-intervention and post-intervention
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for both the experimental (33.15 vs. 37.93 points; mean change: 4.78 points) and control groups (32.00, vs. 33.11 points; mean change: 1.11 points). However, the score change for the experimental group was significantly higher than that for the control group (t=2.530, p=.015).
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The self-efficacy score of the experimental group increased by 1.59 points, from 56.56 points pre-intervention to 58.15 points post-intervention. On the other hand, the control group score decreased
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by 0.73 points, from 58.15 points pre-intervention to 57.42 points post-intervention. The change in the self-efficacy score was significantly different between the groups (t=2.867, p=.006). The self-care performance score of the experimental group increased by 5.22 points, from 85.89 points pre-intervention to 91.11 points post-intervention, while the score of the control group decreased
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by 3.19 points, from 89.77 points pre-intervention to 86.58 points post-intervention. The change in the
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self-care performance score was significantly different between groups (t=3.597, p=.001).
Discussion
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The present study used a randomized controlled trial design to evaluate the effects and utility of a smartphone app developed to facilitate self-care for patients with CHB. The results showed that the
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disease knowledge, self-efficacy, and self-care performance increased significantly in the experimental group compared to in the control group, suggesting that the smartphone app was useful for patients with CHB performing self-care. The pre-intervention mean disease knowledge scores were 33.15 and 32.00 points (out of 49 points) for the experimental and control groups, respectively. The mean score reported by Jeon and Kim (2015), in which the same instrument was used, was 31.15 points, and the score in Yang’s study (2012) was 17.44 points out of a maximum score of 28 points, although the instrument used was not identical to that used herein and in the study by Jeon and Kim (2015). However, when all scores were converted to a 100-point scale, they were similar (experimental: 67 points, control: 65 points; Jeon and Kim: 63 points; and Yang: 62 points). Disease knowledge in various areas, including etiology, vaccination, prevention of infection transmission, and everyday activities, is necessary for patients with CHB to perform self-care
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(Jeon & Kim, 2015). Thus, these relatively low knowledge scores may indicate poor self-care performance. However, in the present study, there was a statistically significant difference in the change
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in knowledge scores between the control and experimental groups post-intervention, indicating that the
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smartphone app may be effective in partially improving the disease knowledge and thereby the self-care of the patients.
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Significant differences were also noted in the changes in the self-efficacy scores between the experimental and control groups. There are numerous ways to increase self-efficacy, including by past
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experiences of achievement, vicarious experience, verbal persuasion, and support from others (Bandura, 1986). In this study, a Role Practices board was used as one of the app menus to improve self-efficacy; this board is believed to have actively contributed to improved participant self-efficacy through understanding of other patients’ experiences of achievement. In addition, once or twice a week, the research assistant used the manager app to send encouraging messages to those registered with the self-care app. Thus, it can be
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speculated that verbal persuasion from specialists and knowledge gained through vicarious experiences contributed to the improvement of self-efficacy in self-care performance in the experimental group. In
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previous studies, the disease knowledge and self-efficacy of the subjects were found to relate to the
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hepatitis virus infection rate, with a high infection rate associated with poor disease knowledge and selfefficacy of the patients (Soto-Salgado et al., 2011; Ha et al., 2013; Kuwabara, & Ching, 2014). Therefore,
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improving the disease knowledge and self-efficacy is important to improve the self-care of CHB patients. There was also a significant difference in the self-care performance score between the
experimental and control groups in this study. The pre-intervention scores of self-care performance were 85.89 and 89.77 out of a maximum score of 115 points for the experimental and control groups, respectively. Using a similar instrument to measure self-care performance, Yang (2012) reported a score of 59.75 out of a maximum score of 75 points, which are in the range of 75–80 points when converted to a 100-point scale. In these two previous studies, as well as in the present study, many participants were recruited from a clinical setting, such as a hospital. Most of these CHB patients receive regular follow-up from the hospital, as well as information and education from the medical staff regarding the disease prognosis and management (Yang, 2012). Therefore, the level of self-care is expected to be relatively high. Previous studies have reported that the degree of self-care and management in patients with hepatitis B infection affects the chronicity of the disease (Mohamed et al., 2012; Nkonge et al., 2012), 12
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further confirming the importance of self-care. However, in Korea, only about 25% of patients with CHB are aware that they are infected, and less than 20% of those who are aware reportedly care for their health
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and consistently receive follow-up and disease management from a hospital (Korean Association for the
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Study of the Liver, 2011). Accordingly, a smartphone app that anyone can easily use may be an effective medium to improve self-care performance in patients with CHB. Indeed, in a variety of other diseases such
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as chronic heart disease, diabetes mellitus, obesity and stroke, smartphone apps have been reported to improve the self-care of the subjects (Miller et al., 2014; Jo & Park, 2016; Sureshkumar et al., 2016),
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supporting the results of the present study.
The smartphone app developed in this study had an effect similar to that reported in a previous study of a self-management program for patients with CHB (Yang, 2012). In that previous study, the experimental group, who underwent the self-management program, showed greater improvements in disease knowledge, self-efficacy, coping behavior, and self-management performance than the control
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group, and the effects persisted over time. However, a large proportion of patients with CHB are at an economically active age, and may not have time to attend a program outside of their home on a
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predetermined schedule (Che et al., 2013). Thus, since there are no specified time or location
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requirements, a smartphone app is expected to have a stronger effect, because it can effectively deliver an intervention to a high number of patients (Cuenca et al., 2014).
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As the number of patients with chronic diseases is rapidly increasing worldwide, demands for a healthcare system centered around hospital-provided disease management, prevention, and patientcustomized services are increasing (Sureshkumar et al., 2016). In particular, the u-Health Service is a healthcare service in a ubiquitous computing environment that enables patient-customized services by combining healthcare and information technology. For patients with chronic diseases, the u-Health Service should be based on medical services and guidelines provided by hospitals and aim to improve patient health through self-management (Miller et al., 2014). If the smartphone app developed in this study can be linked to hospitals and be used to provide patient-customized services, it would represent a cost-effective mechanism for improving the self-care performance of patients with CHB and could potentially improve their overall health. Evaluation and discussion about the continuity and interaction feedback of the self-regulation process is necessary. In a survey conducted during the analytic phase of the development of this 13
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smartphone app, positive values for attitudes, beliefs, outcome expectations, and expected values of a smartphone app for the target population were identified (Jeon, 2015). The outcome expectation with the
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highest response rate for use of the app was, "I am curious about how to manage CHB" (Jeon, 2015).
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Consistent with this expectation, the participant utilization rate of the "Self-Care" menu gradually increased over time. This behavior was also reflected in the analyses of the effects of the smartphone app
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in the present study. In the experimental group, the disease knowledge, self-efficacy, and self-care performance significantly increased from the pre-intervention levels, indicating that the use of the
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smartphone app, for as little as 12 weeks, positively affected the users through interactions with intrapersonal and external factors, and, to a certain degree, helped them achieve step-wise responses and purpose through continuous observations and judgments (Clark et al., 2001). However, managing a chronic disease requires both short-term and continuous self-management (Sureshkumar et al., 2016). Therefore, a long-term study is needed in the future to evaluate the interaction feedback and continuity in
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patients with CHB who use this smartphone app and to identify factors impeding the interaction feedback and continuity.
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There were some limitations to this study. The psychological aspects and quality of life of patients with
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CHB were not considered in the smartphone app. Patients with CHB commonly complain of fatigue, reduced work ability, depression, and anxiety, and these symptoms have negative impacts on their quality
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of life, as well as mental and physical well-being (Che et al., 2013). For patients with CHB, the quality of life is often negatively affected early in the disease course, not only because the patients may be withdrawn from interpersonal relationships due to anxiety accompanied with the possibility of transmitting the disease to others, but also because the disease could ultimately progress to cirrhosis or hepatocellular carcinoma, for which curative treatment approaches are limited (Park et al., 2003). Nonetheless, the medical providers focus mainly on the treatment of the symptoms, and often do not consider the psychological aspects and quality of life while treating the patients (Che et al., 2013). In addition, little research has been conducted on the quality of life of patients with CHB (Park et al., 2003). Hence, when the app used in this study is updated in the future, functions related to psychological aspects and quality of life should be added.
Conclusions 14
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Herein, it was confirmed that a recently developed smartphone app for patients with CHB had positive effects on self-care performance. The results of this randomized controlled trial demonstrated
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that the disease knowledge, self-efficacy, and self-care performance improved in the experimental group
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compared to in the control group, indicating the effectiveness of the app for CHB patients.
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Acknowledgments
This article is based on the first author’s doctoral dissertation from Chung-Ang University in Korea
commercial, or not-for-profit sectors.
Conflicts of interest
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None
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(unpublished). This research did not receive any specific grant from funding agencies in the public,
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Table 1. Baseline Characteristics of the Experimental and Control Groups
(n=27) n (%)
(n=26) n (%)
Categories
Male
24 (88.9)
Female
3 (11.1)
20-39
15 (55.6)
≥40
12 (44.4)
17 (65.4)
39.44±10.15
44.69±9.57
21 (77.8)
23 (88.5)
Age (years)
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Mean ± SD
Married and living together Marital status Other Yes Working
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No ≤ High school Education level
≥ University
6 (22.2)
3 (11.5)
26 (96.3)
24 (92.3)
1 (3.7)
2 (7.7)
3 (11.1)
4 (15.3)
3 (11.1)
4 (15.4)
Moderate
20 (74.1)
18 (69.2)
Poor
4 (14.8)
4 (15.4)
Seoul/Gyeonggi/Incheon
10 (37.0)
12 (46.2)
Gangwon/Chungcheong
5 (18.5)
2 (7.7)
Jeolla/Gyeongsang
9 (33.3)
10 (38.5)
Jeju/Country other than Korea
3 (11.1)
2 (7.7)
≤10
4 (14.8)
5 (19.2)
11-20
17 (63.0)
12 (46.7)
≥21
6 (22.2)
9 (34.6)
Yes (once)
6 (22.2)
8 (30.8)
admission due to CHB
Yes (> 1 time)
1 (3.7)
1 (3.8)
No
20 (74.1)
17 (65.4)
Remembers last
Yes
23 (85.2)
20 (76.9)
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Good
Area of residence
(years)
Hospital
19
1.000
2.344
.126
1.072*
.467
0.395*
.610
1.795*
.719
0.347*
.911
1.729*
.701
1.581*
.493
1.922*
1.000
0.593*
.501
9 (34.6)
22 (84.6)
Duration of CHB
0.670*
2 (7.7)
24 (88.9)
Economic status
p
24 (92.3)
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Sex
χ2
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Control
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Experimental
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Control
(n=27)
(n=26)
n (%)
n (%)
No
4 (14.8)
6 (23.1)
Other hepatitis
Yes
1 (3.7)
treatment besides HME
No
26 (96.3)
23 (88.5)
Once a month
4 (14.8)
4 (15.4)
Every three months
19 (70.4)
15 (57.7)
4 (14.8)
7 (26.9)
23 (85.2)
19 (73.1)
4 (14.8)
7 (26.9)
Characteristics
Categories
for HME
Every six months Treated with AVHD
Yes No
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Regular follow-up
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(GOT, GPT)
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blood test result
p
2.977*
.430
-0.438
.663
1.277*
.503
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liver
χ2
2 (7.7)
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*= Fisher’s exact test; SD = standard deviation; CHB = chronic hepatitis B; GOT = glutamic oxaloacetic transaminase; GPT = glutamic pyruvic transaminase; HME = hospital medical examination; AVHD = anti-viral hepatitis drugs.
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Table 2. Homogeneity of Dependent Variables Pre-intervention Control (n=26) M ± SD
Disease knowledge
33.15 ± 7.15
32.00 ± 8.58
Self-efficacy
56.56 ± 4.92
Self-care performance
85.89 ± 7.00
t
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Experimental (n=27) M ± SD
.598
58.15 ± 5.08
-1.142
.259
89.77 ± 8.96
-1.760
.084
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M ± SD = Mean ± Standard Deviation.
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p
0.530
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Variables
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Table 3. Comparison of Disease Knowledge, Self-Efficacy, and Self-Care Performance Pre- and PostIntervention Post-test
Difference
M ± SD
M ± SD
Experimental (n=27)
33.15 ± 7.15
37.93 ± 6.99
4.78 ± 4.23
Control (n=26)
32.00 ± 8.58
33.11 ± 8.62
1.11 ± 6.16
Experimental (n=27)
56.56 ± 4.92
58.15 ± 5.08
1.59 ± 2.80
Control (n=26)
58.15 ± 5.27
57.42 ± 4.44
-0.73 ± 3.09
Experimental (n=27)
85.89 ± 7.00
91.11 ± 8.27
5.22 ± 10.42
Control (n=26)
89.77 ± 8.96
Self-care performance
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M ± SD = Mean ± Standard Deviation.
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Self-efficacy
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knowledge
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Disease
Group
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Pre-test M ± SD
Variables
86.58 ± 7.06
-3.19 ± 5.92
t
p
2.530
.015
2.867
.006
3.597
.001
Figure 1. Study Conceptual Framework
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Figure 2. Participant CONSORT flow diagram
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(b)
(c)
(d)
(e)
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(a)
Figure 3. Intervention smartphone application screens for users: (a) Main screen; (b) Self-care screen; c) Knowledge of disease screen; (d) Lab data record screen; (e) Statistics screen.
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Highlights - Disease knowledge has a significant effect on the performance of self-care of chronic hepatitis B.
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- Self-efficacy has a significant effect on the performance of self-care of chronic hepatitis B.
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- Smartphone applications can help facilitate disease knowledge and self-care of chronic hepatitis B.
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