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Building skill in heart failure self-care among community dwelling older adults: Results of a pilot study
Accepted Manuscript Title: Building Skill in Heart Failure Self-Care among Community Dwelling Older Adults: Results of a Pilot Study Author: Victoria Vaughan Dickson Gail D’Eramo Melkus Stuart Katz Alissa Levine-Wong Judy Dillworth Charles M. Cleland Barbara Riegel PII: DOI: Reference:
S0738-3991(14)00179-7 http://dx.doi.org/doi:10.1016/j.pec.2014.04.018 PEC 4780
To appear in:
Patient Education and Counseling
Received date: Revised date: Accepted date:
11-1-2014 19-4-2014 28-4-2014
Please cite this article as: Dickson VV, Melkus GDE, Katz S, Levine-Wong A, Dillworth J, Cleland CM, Riegel B, Building Skill in Heart Failure Self-Care among Community Dwelling Older Adults: Results of a Pilot Study, Patient Education and Counseling (2014), http://dx.doi.org/10.1016/j.pec.2014.04.018 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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Building Skill in Heart Failure Self-Care among Community Dwelling Older Adults:
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Victoria Vaughan Dickson, PhD College of Nursing, New York University New York, USA
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Results of a Pilot Study
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Gail D’Eramo Melkus, EdD College of Nursing, New York University New York, USA
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Stuart Katz, MD School of Medicine, New York University New York, USA
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Alissa Levine-Wong, BS, BA, RN College of Nursing, New York University New York, USA
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Judy Dillworth, MS, BS, RN College of Nursing, New York University New York, USA
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Charles M. Cleland, PhD College of Nursing, New York University New York, USA
Barbara Riegel, DNSc School of Nursing, University of Pennsylvania Philadelphia, USA
Corresponding Author at Victoria Vaughan Dickson, PhD, CRNP College of Nursing New York University 726 Broadway,10th Floor New York, NY, USA 10003 Phone: 212-992-9426 Fax: 212-995-4564 Email: [email protected]
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Abstract Objective: Most of the day-to-day care for heart failure (HF) is done by the patient at home and
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requires skill in self-care. In this randomized controlled trial (RCT) we tested the efficacy of a community-based skill-building intervention on HF self-care, knowledge and health-related
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quality of life (HRQL) at 1-and 3-months.
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Methods: An ethnically diverse sample (n=75) of patients with HF (53% female; 32% Hispanic, 27% Black; mean age 69.9±10 years) was randomized to the intervention group (IG) or a wait-
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list control group (CG). The protocol intervention focused on tactical and situational HF self-care skill development delivered by lay health educators in community senior centers. Data were
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analyzed using mixed (between-within subjects) ANOVA.
Results: There was a significant improvement in self-care maintenance [F(2,47) =3.42, p=.04,
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(Cohen’s f =.38)], self-care management [F(2,41) =4.10, p=.02, (Cohen’s f =.45) and HF
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knowledge [F (2,53) =8.00, p=.001 (Cohen’s f =.54)] in the IG compared to the CG.
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Conclusions: The skill-building intervention improved self-care and knowledge but not HRQL in this community-dwelling sample.
Practice implications: Delivering an intervention in a community setting using lay health educators provides an alternative to clinic- or home-based teaching that may be useful across diverse populations and geographically varied settings.
Key Words: Heart failure, Self-care, treatment adherence, symptom monitoring decision-making, health educators Acknowledgements: This study was funded by the American Heart Association Clinical Research Program Grant: 10CRP4140049, PI: VV Dickson.
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Introduction
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Heart failure (HF) is a global epidemic affecting over 23 million people worldwide[1]with an associated economic burden estimated at more than $108 billion per
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year.[2] Despite advances in HF treatment, outcomes remain dismal with significant symptom
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burden, low functional capacity, poor health-related quality of life (HRQL),[3, 4] frequent hospitalizations,[5] and early mortality.[6]
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Even with innovations in technology, most of the day-to-day care for HF is done by the patient at home[7] and involves self-care. Self-care is defined as a naturalistic decision-making
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process that includes self-care maintenance, those behaviors performed to maintain physiological stability (e.g., treatment adherence, symptom monitoring) and self-care management, which is
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the response to HF symptoms when they occur.[8] Patients who engage in self-care have fewer
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symptoms, better functional capabilities and better HRQL.[5] Conversely, as many as 50% of HF
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patients are readmitted within three to six months of a hospital discharge due to poor self-care.[9,
International HF practice guidelines[11, 12] specify the need for HF self-care education. Despite more than a decade of self-care intervention research, self-care in the HF population remains very poor.[13, 14] One promising approach is disease management, a system of coordinated healthcare interventions and services often incorporating telemonitoring.[15] Yet, even these intense interventions have a significant rate of failure, with many patients readmitted for acute shortness of breath or large weight gains attributed to poor HF self-care.[16, 17]
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Other traditional methods of self-care education usually involve a didactic process focused primarily on improving knowledge about HF and self-care practices. This education usually
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takes place in a clinical setting with limited consideration of the sociocultural factors that influence self-care.[18] Studies have shown that knowledge, which refers to learning concepts or
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information[19] is necessary for effective self-care, but not sufficient to improve behavior.[20]
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Adequate self-care requires skill in performing routine behaviors as well as skill in making decisions about signs and symptoms.[21] Skill refers to the ability to use information and apply it
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in a context,[19] i.e., carry out a task with a pre-determined result. In HF, self-care skill evolves over time and with practice as patients learn how to make self-care practices fit into their daily
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lives and as they gain experience in successfully managing symptoms. 1.1 Conceptual Model
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This study is guided by the situation-specific theory of HF self-care.[22] Accordingly, self-
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care is a naturalistic decision-making process in which persons engage for the purpose of
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maintaining health and managing their illness. This framework explains that in real world settings people make decisions that are meaningful and familiar to them.[23] Real life decisions are influenced by the interaction between the individual, the problem, and the current setting or environment.[22] Self-care decisions, for example, on whether to take medication or act early on symptoms, are situation and context specific, influenced by a person’s knowledge about and experience with decision making in the particular context, skill, and the compatibility of the decision and action with their values (figure 1). Guided by this theoretical framework, an intervention to improve self-care must not only increase knowledge about HF self-care, but also build skill in all aspects of self-care including unique situations. An intervention that is not consistent with one’s values, which are shaped by
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sociocultural factors, will not be used consistently over time.[22] Individuals who have the requisite knowledge, skills and experience are more likely to make an effective self-care decision.
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In turn, the outcomes of that self-care decision, (e.g., medication adherence, effective management of symptoms) will manifest as fewer symptoms, increased functional capacity and
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improved quality of life. These successful outcomes serve to reinforce future decision-making
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about self-care. 1.2 Objectives
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The primary purpose of this study was to pilot test an innovative skill-building intervention to improve HF self-care among community-dwelling older adults. Specifically, the aims of this
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randomized controlled trial (RCT) were to test efficacy of this theoretically-derived intervention at 1 and 3 months. We tested three hypotheses comparing 75 older adults with HF randomly
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assigned to an intervention (IG) or a wait-list control group (CG):
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Hypothesis 1. Participants in the IG will have significantly improved HF self-care than CG.
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Hypothesis 2. Participants in the IG will have significantly improved knowledge about HF and HF self-care than CG
Hypothesis 3. Participants in the IG will have significantly better HRQL than CG. 2. Methods
2.1 Study Design
The complete methods of this study have been described elsewhere.[24] Briefly, to achieve the aims of the study, we employed a staggered randomized controlled design in which individuals were randomized to the intervention (IG) or to a wait-list control group (CG) that was offered the intervention after 3 months. Individuals randomized to the intervention arm participated in a group-based self-care intervention focused on building skill in essential self-care
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maintenance behaviors (e.g., following a low salt diet) and effective self-care management (e.g., symptom recognition).[21] The intervention was delivered by a trained health educator and was
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held in 3 community senior centers serving an urban, diverse, ethnic minority and low socioeconomic (SES) population.[24]
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2.2 Participants
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A convenience sample of older adults with HF was recruited from cardiology clinics and community settings in the northeastern US geographical area surrounding the clinical sites.
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Recruitment strategies included informational fliers posted in community settings (e.g., senior centers) and referrals by clinical providers familiar with the study. Individuals were
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eligible to participate if they had a diagnosis of chronic HF for at least 3 months,[25] were able to read and speak English or Spanish, were over age 55, and were living in a setting where they
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were able to engage in self-care (e.g., not in a long term care setting). Individuals were excluded
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if they had a cognitive impairment significant enough to interfere with study participation, as
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screened by administration of the Clock Drawing Test[26]. All participants provided written informed consent. The study protocol was approved by the appropriate university and clinical Institutional Review Boards.
The study was designed to have at least 80% power (alpha =.05) to detect a significant difference between the intervention and control group[27] assuming a 20% attrition rate. Thus, 75 participants were required to result in a final sample size of 60 (30 per group). A total of 250 individuals with HF were assessed for eligibility; 144 met the inclusion criteria and were approached for participation. Of those, 75 individuals were subsequently enrolled and randomized in the trial to the IG (n=38) or to the CG (n=37) (figure 2). Fifty-six individuals provided data for analysis in this study. The major reason for attrition across both the IG
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(n=5) and the CG (n=8) was inability to contact individuals for follow up. Other reasons included changes in personal status (e.g., transportation issues, non-HF related health
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issues) that prevented individuals from participating. In this study covariate adaptive randomization was used to achieve balance for
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treatment assignment within specific strata (i.e., gender, race, financial status). The PI used
and control for extraneous sources of variation.[29]
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2.3 Intervention
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Minim,[28] a software program to randomly assign participants to either the IG or the CG
The essential elements of the self-care skill building intervention are based on our prior work
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that adequate self-care requires skill in the daily behaviors related to self-care maintenance (e.g., adherence to a low salt diet, complex medication regimens, symptom monitoring) and skill in
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making decisions about signs and symptoms (e.g., diuretic titration).[21] The theoretically-
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based intervention[24] was designed to be delivered in a group setting by a lay health educator.
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This model leveraged the unique role of health educators who have a baccalaureate degree and credentialing in health education,[30] to promote skill-building in self-care using a well-defined protocol, provide reinforcement of the clinical plan of care and additional lifestyle coaching related to HF self-care, and facilitate problem solving including access to care.[31] Briefly, the skill building self-care intervention began with an assessment of each individual’s current knowledge of HF, level of tactical skill (e.g., low salt meal preparation), and any specific situations (e.g., cultural and social norms) that needed to be considered in building these skills. Skill-building exercises focused on skill deficits (e.g., how to read food labels) and managing common as well as unique situations (e.g., ordering food when eating out, managing diuretics while traveling) through practice and role-playing exercises.
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The intervention was delivered in a group setting of 4-8 participants and held in a community senior center. Twice weekly 60 minute sessions were provided over the course of 4
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weeks, led by a health educator who had received training in the protocol from the Principal Investigator. Content of the sessions focused on 4 major areas of the self-care process: 1)
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medication adherence, 2) low-salt diet, 3) symptom monitoring, and 4) symptom management.
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The intervention was offered in English and Spanish, the latter by a bilingual health educator. To ensure treatment fidelity, all intervention sessions were audiotaped and transcribed
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verbatim. Each transcription was reviewed using a performance criteria checklist to score the health educator’s adherence to the study protocol. In addition, the health educator kept notes for
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each session and debriefed weekly with the research team. Using this treatment fidelity method we ensured that the intervention was delivered as intended. Indeed, there was 94% adherence to
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the protocol by the health educators during the study period.[32]
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Individuals who were randomized to the wait-list CG received usual care that included any
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standard patient education information provided by their healthcare providers. After the last data collection point, they were offered enrollment into the intervention. Of the 37 who were initially randomized to the CG, 15 (40%) voluntarily went on to attend the intervention sessions. 2.4 Procedures
Data collection took place at baseline, 1 month and 3 months. At baseline, sociodemographic characteristics (e.g., age, gender, ethnicity, education), length of HF diagnosis, and medications were obtained by self-report. Valid and reliable instruments, described further below, were used to collect data on New York Heart Association (NYHA) class, co-morbid conditions and physical functioning in order to describe the sample. The major outcomes of self-care, knowledge and HRQL were collected at baseline and at 1- and 3-months.
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2.5 Outcome Variables Self-Care was measured using the Self-Care of Heart Failure Index (SCHFIV6.2)[27], 22
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items evaluated on a 4-point response scale. The SCHFI self-care maintenance scale, which reflects treatment adherence and monitoring and the self-care management scale, which
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measures response to symptoms when they occur, were used in this study. The SCHFI has been
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shown to be sensitive to subtle behavioral changes in a variety of HF samples. In this study the alpha coefficients were .60 and .65 respectively, values consistent with other studies.[33]
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Knowledge of HF was assessed using the Dutch HF Knowledge Scale (DHFKS).[34] The scale consists of items concerning HF knowledge in general, knowledge of HF treatment and HF
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symptoms. The content of the items is based on established patient education guidelines. In this study the alpha coefficient was .64, similar to reliability reported by the test developers.
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Health-related quality of life (HRQL), defined as a subjective sense of well-being
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encompassing physical, psychological, social, and spiritual dimensions related to health and
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healthcare[35] was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ).[36] The KCCQ is a 23-item questionnaire that quantifies disease-specific physical limitation, symptom frequency, severity, and change over time, overall quality of life, social interference, and self-efficacy—those dimensions shown to be key aspects of HRQL in persons with HF. In this study the alpha coefficients were adequate (range .72 to .92) and similar to the internal consistencies reported in another sample of people with HF.[36] The analysis in this study used the clinical summary scale score, which is comprised of the physical limitations and symptomrelated domains and the overall summary score. In addition to the outcome variables, clinical characteristics pertinent to HF self-care were collected using valid and reliable instruments. NYHA classification was assigned by a single
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cardiovascular nurse blinded to study participant status using a standardized questionnaire.[37] Comorbidity was measured using the interview format of the Charlson Comorbidity Index
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(CCI)[38] and responses were categorized into low, moderate, or high according to published methods.[39] Physical functioning was assessed by the Duke Activity Status Index (DASI). The
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DASI measures the individual’s ability to perform a range of specific daily activities and has
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adequate correlation with functional capacity measures.[40] In this study the Cronbach’s alpha was .78.
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2.6 Data Analysis
Descriptive statistics were used to describe baseline sociodemographic and clinical
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characteristics and outcomes (self-care, knowledge and HRQL). Chi-square and independent samples t-tests were used to examine differences at baseline based on group assignment.
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Changes in self-care, knowledge and HRQL were analyzed at 1-month and at 3-months. To test
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the three hypotheses regarding the effect of the intervention on improving HF self-care,
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knowledge and HRQL at 1-month and 3-months, a mixed model (between and within subject) analysis of variance (ANOVA) was conducted. Participant scores on the SCHFI (self-care maintenance and self-care management scales), DHFKS (knowledge) and the KCCQ (HRQL clinical summary and overall summary scores), were assessed across three time periods (baseline, 1-month and 3-months). In addition, the interaction between treatment (between-subjects factor) and time (within-subjects factor) on measures of self-care, knowledge and HRQL was assessed. Finally, Cohen’s f was calculated as a standardized index of effect sizes. Analyses were conducted using IBM SPSS v. 21.0 (Chicago, IL). An intention-to-treat analysis was performed. 3. Results 3.1 Participant Characteristics
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Table 1 presents the sociodemographic and clinical characteristics of the sample. The sample (53% female, mean age 69.9±10 years) was comprised mostly of ethnic minority adults (32%
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Hispanic, 27% Black, 14% other non-white). Most in this sample lived alone (58%) and 44% reported insufficient financial income. Seventy percent were in NYHA class II (mildly
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symptomatic) with at least 3 chronic conditions. The IG was slightly older than the CG (72±10.4
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years vs. 67± 9.4years, p=.05) but the CG reported more comorbid conditions (p=.001) and overall poorer perceived health status (p=.02). The CG also reported poorer physical functioning
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as measured by the DASI than the IG (13.8±10 compared to 20.6±14, p=.04). At baseline, there were no significant differences in self-care maintenance, self-care
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management or knowledge scores between the two groups. However, HRQL was significantly higher in the IG than the CG (KCCQ clinical summary score: 82.9±17 vs. 69.1±23, p = .01;
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KCCQ overall summary score: 80.1±17 vs. 66.2±24, p = .01) (shown in Table 2).
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Seventy-five percent (n=56) completed the 3-month assessment with no differences between
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completers and noncompleters in baseline sociodemographic or clinical characteristics. A total of 34 (90%) of individuals randomly assigned to the IG completed the first class with the health educator and a mean of 5.7± 0.5 classes of the 8 sessions offered. 3.2 Outcomes
As shown in table 2, two of our hypotheses were supported. Participants in the IG had improved self-care (hypothesis 1) and knowledge (hypothesis 2) but not HRQL (hypothesis 3). Figure 3 shows the estimated marginal means for self-care maintenance (3A), self-care management (3B) and knowledge (3C) for each group at each point in time. 3.2.1 Self-Care Maintenance
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Self-care maintenance improved in the IG compared to the CG. There was a significant interaction between the group and time, F(2, 47)=3.42, p=.041, (partial eta squared =.13)
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(figure 3A) suggesting effectiveness of the intervention in improving self-care maintenance. The interaction effect size was moderate (Cohen’s f = .38).
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3.2.2 Self-Care Management
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There was also significant improvement in self-care management in the IG but not the CG over the 3 month study period, with a significant interaction effect, F (2,41) =4.10,
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p= .024, (partial eta squared = .17) (figure 3B). The interaction effect size was large (Cohen’s f = .45).
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3.2.3 Knowledge
Similar results were seen in the third outcome of knowledge and suggest the
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effectiveness of the intervention in improving knowledge. There was a significant
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interaction effect, F (2, 53) =8.00, p= .001, (partial eta squared = .23) (figure 3C). The
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interaction effect size was large (Cohen’s f = .54). 3.2.4 HRQL
There was no significant difference in HRQL between the IG and the CG. There was a significant main effect of group in the KCCQ clinical summary score, F (1,36)=4.11, p=.05 and the overall summary score F(1,36) =4.66, p=.04 but no interaction effect in either measure of HRQL. That is, both groups improved over time suggesting no significant effect of the intervention on HRQL. 3.2.5 Adjustments for Baseline Differences in Participant Characteristics Additional analysis was conducted to take into account baseline differences in age, perceived health, comorbidity and physical functioning. Age, comorbidity and physical
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functioning were weakly and not significantly correlated with the dependent variables. Perceived health was significantly correlated with self-care maintenance (r=.328, p<.05)
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and HRQL (r=.451, p<.01). When perceived health was added as a covariate to an adjusted model described in Sections 3.2.1-3.2.4 above, conclusions drawn were no different than for
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the unadjusted analysis.
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4. Discussion and Conclusions
To our knowledge, this is the first study to describe the effects of a community-based skill
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building intervention in community dwelling ethnically diverse patients with HF. The intervention improved the essential behaviors of self-care maintenance and management as well
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as knowledge about HF. These results are consistent with prior reports of community-based interventions in non-HF chronic disease populations.[41-43] For example, Glazer et al’s
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systematic review reported that utilizing a community-based group setting for diabetes self-care
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resulted in improved meal planning, symptom monitoring and symptom management and
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promoted lasting changes in lifestyle behaviors,[41] which are similar to the self-care requirements of HF. Sustainability of behavior change in patients with diabetes was attributed to the social support network that evolved over time during the intervention. Similarly, our results of improved self-care at 1-month suggest the effectiveness of the group environment that allowed for ongoing support and dialogue with experts and peers. Therefore, we are optimistic that the significantly better self-care results at 3-months in the intervention group reflect the potential for sustainability of the intervention, but a longer follow up period is necessary to capture the lasting effects. Our study also showed an improvement in knowledge that has been frequently reported.[4446] However, our findings of improved self-care in addition to knowledge are noteworthy and
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strengthen the evidence for effectiveness of the intervention overall. Recently, Davis et al. reported improved knowledge but not self-care in their intervention trial, which reinforced
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that knowledge alone is not sufficient to improve self-care.[46] They concluded that individuals may not have been able to translate knowledge into self-care behaviors and offered
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the explanation that their intervention did not address the confidence or self-efficacy that is
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necessary for self-care. Our intervention that specifically focused on skill-building addresses the gap between knowledge and self-care. Intervention components like role-playing and
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reinforcement through practice exercises as used in our intervention[24] help people translate the content into practice. These methods are also known to promote self-efficacy,[47] and thus may
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have contributed to the positive results in self-care maintenance and management compared to others.
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Our intervention did not appear to have any effect on HRQL as measured by the clinical
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summary and overall summary score of the KCCQ. The current literature is equivocal on the
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effect of self-care interventions on HRQL. Many interventions are tested on patients after a clinical event such as a hospitalization.[48, 49] Literature reviews describing short term effects of various interventions on HRQL have suggested that the initial uptick in HRQL is related to the post discharge transition rather than the self-care intervention. It may be that since our sample was a clinically stable, community-dwelling population and recruited from the community and outpatient settings, rather than after a clinical event, we did not see an improvement in HRQL. Others have suggested that self-care is burdensome.[50] So it may be that the lack of any significant change in HRQL reflects the work of engaging in self-care more routinely.[51] A longer intervention may be needed to reinforce the self-care behaviors and demonstrate an improvement in HRQL[52] in those who may feel otherwise burdened over time.
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Another novel aspect of our intervention is the use of the health educator. Previous studies have demonstrated efficacy of chronic disease interventions implemented by health educators or
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community health workers (CHW),[53] but not in HF, to date. Notably, in the COACH trial, a comprehensive management intervention that tested a nurse practitioner/CHW collaboration
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compared to enhanced usual care, Allen et al (2011) reported significant results in cardiac risk
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reduction in the intervention group.[54] Others also have reported effective use of health educators to deliver health programs especially in underserved, low-socioeconomic, minority
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populations with chronic diseases such as hypertension, diabetes, HIV, and asthma.[53, 55-57] The role of the health educator in our study was similar in that health educators were trained in
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the use of a well-developed intervention protocol and focused on self-care, provided reinforcement of the self-care components of the clinical plan of care and facilitated problem
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solving with program participants. Our results, therefore, suggest that the health educator model
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may be an alternative to clinician-based approaches, especially when the focus of the
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intervention is on promoting self-care. 4.1 Limitations
The small sample size limited the ability to conduct subgroup analysis, for example, by NYHA class or race. The randomization procedure in this study was deterministic[58] and achieved covariate balance as intended, but the sample size was insufficient to achieve balance in age, comorbidity, physical functioning and perceived health. In the future, a larger RCT using randomization procedures that balance the group assignment is warranted. The study is also limited by the attrition rate. Several substantial weather events in the geographical region (e.g. superstorm Sandy) that occurred during the period of the study (2010-2012) made contacting participants difficult, thereby interrupting the
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enrollment process and data collection, and resulting in missing data for the 3-month follow-up. We also acknowledge that the urban community settings used in this study may be
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unique and may not reflect the ethnic minority and low SES population at large. Another limitation is the lack of a cost-effectiveness analysis.[59] Since patients with HF experience
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high symptom burden and exorbitant healthcare costs, understanding how this
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intervention might decrease health care costs is needed.
Despite these limitations, the study had numerous strengths including the ethnically
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diverse sample and strong treatment fidelity monitoring that support the results. This study provides important preliminary evidence of effectiveness of a community-based program for HF
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self-care and is a necessary step in the clinical translation of the intervention for use in other
4.2 Conclusions
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geographically diverse populations..
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To date, most HF self-care interventions have focused on reacting to an adverse event such as
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a hospitalization or emergency room visit and providing educational content to improve knowledge about HF and self-care. Disease management programs highlight clinical management during transition periods. The results of these approaches have been mixed and often not sustained,[49, 60] perhaps because they fall short in preparing patients to engage in self-care within the context of their daily lives and community resources. Improving self-care among ethnic minority patients with HF has been notoriously challenging. This study provides preliminary evidence of the efficacy of a community-based skill building self-care intervention delivered by health educators. The promising results suggest that focusing on the development of essential tactical and situational skills in self-care maintenance and management may help sustain effective self-care.
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4.3 Practice implications The results of this RCT suggest a shift in the paradigm of HF self-care interventions from
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reactive (e.g., to a clinical event) to the proactive engagement of community-dwelling adults in an intervention that will improve and sustain self-care among diverse populations with HF. The
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skill-building approach was effective in improving self-care maintenance and self-care
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management as well as knowledge. This study has important implications for the growing population of community-dwelling adults with HF because it leverages community resources.
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Providing the intervention in the community setting using trained health educators provides a practical solution that can be implemented across diverse populations and geographically varied
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settings.
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I confirm all patient/personal identifiers have been removed or disguised so the
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of the story.
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patient/person(s) described are not identifiable and cannot be identified through the details
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Legends
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Figure 1: Conceptual model of self-care as a naturalistic decision making process. Decisions are made about behaviors in which to engage and how to respond to symptoms when they occur.
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Self-care decisions are situation and context specific, influenced by a person’s knowledge about
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and experience with decision making in the particular context, skill to act on the decision made, and the compatibility of the decision and action with their values. Self-care decisions that lead to
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successful outcomes reinforce future decision-making about self-care.
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Figure 2: Consolidated Standards of Reporting Trials (CONSORT) diagram of the pilot study.
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Figure 3: Estimated Marginal Means for outcomes of self-care maintenance (3A), self-care
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management (3B) and knowledge (3C) by group and each time period.
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.
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Table 1: Sociodemographic and clinical characteristics of sample Intervention
Control
(n=75)
(n=38)
(n=37)
69.9(10)
72(10.4)
35 (47%)
Female
40 (53%)
22 (58%)
an
Ethnicity
16 (42%)
us
Male
67(9.4)
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Gender
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Age, years
Total
.75 11 (30%)
Hispanic
24 (32%)
12 (32%)
12 (32%)
White
20 (27%)
12 (32%)
8 (22%)
Other
11 (14%)
5 (12%)
6 (16%)
13(3)
13.2(3.3)
12.7(3.4)
te
d
M
9 (24%)
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.49
18 (48%)
20 (27%)
Marital Status
.05*
19 (52%)
Black
Education, years
P
.59 .26
Married
14(22%)
7 (19%)
7 (25%)
Widowed
15 (23%)
8 (22%)
7 (25%)
Divorced, separated, never
35(45%)
21 (58%)
14 (50%)
married
Living arrangements
.41
Lives alone
37 (58%)
23(62%)
14 (52%)
Lives with others
27 (42%)
14 (38%)
13 (48%)
Financial status Comfortable, more than enough
.62 14(19%)
8 (21%)
6 (16%)
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Enough to make ends meet 28 (37%)
14 (37%)
14 (37%)
33 (44%)
16 (42%)
17 (47%)
Over perceived health
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Not enough to make ends meet
Very good
13 (21%)
12 (32%)
Good
17 (27%)
9 (24%)
8 (29%)
Fair
28 (44%)
15 (41%)
15 (54%)
Poor
5 (8%)
1 (3%)
4 (14%)
7.5(7.1)
M
NYHA Class
1 (4%)
cr
us
an
Length of HF diagnosis, years
7.4(7.4)
7.4(6.8)
27(66%)
18 (67%)
III
19 (30%)
10 (34%)
9 (33%)
2.8(1.5)
4.3(1.8)
Low
te
Comorbidity category
d
45(70%)
3.4(1.8)
15 (41%)
6 (22%)
Med
25 (39%)
16 (43%)
9 (33%)
High
18 (28%)
6 (16%)
12 (44%)
17.5(13)
21.0(14)
13.3(11)
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.001** .06
21 (33%)
Physical functioning (DASI)
.98 .59
II
Comorbidity score
.02*
.02*
Data are presented as Mean( SD) or N (%) Abbreviations: ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotnesn receptor blocker; DASI, Duke Activity Status Index; HF, Heart Failure, ; NYHA, New York Heart Association;
Page 28 of 35
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an
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Table 2: Changes in Outcomes by Group and Over Time
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IG
CG M(SD)
Cohen’s f
P
M(SD)
30
SCHFI Self-Care Maintenance
. 63.9(15
1-month
)
3-months
75 (12)
58.5(18)
0
64.4(17)
4
64.5(16)
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Baseline
80.6(9)
.
45.8(24)
65.7(18
48.3(24)
)
0 2
49.4(21)
an
3-months
us
1-month
43(21)
.45*
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SCHFI Self-Care Management Baseline
.38*
66.8(18
M
) DHFKS Knowledge
10(3)
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3-months
te
1-month
9.6(3)
0
13(2)
10(3)
0
12.7(1)
10.1(3)
1
d
Baseline
.
KCCQ Clinical Summary
.
Score
Baseline
80.3(17 )
1-month
3-months
84.5(14
65.7(29)
9
69.8(31)
8
.54**
.03
70.3(30)
) 84.5(13 )
KCCQ Clinical Summary
.
Score Baseline 1-month 3-months
76(18)
63.6(28)
2
83.4(13
64.3(24)
2
)
66.5(23) 79.1(16
.20
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Data presented as Mean(standard deviation) P values are for the interaction effect (group x time)
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Key: CG: Control Group; DHFKS: Dutch Heart Failure Knowledge Scale, IG: Intervention
us
Group; KCCQ: Kansas City Cardiomyopathy Questionnaire; SCHFI; Self-Care of Heart Failure Index
Ac ce p
te
d
M
an
Cohen’s f * = moderate effect size; **= large effect size
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te
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an
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Figure 1
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Figure 2 Excluded n= 106 Age n=43 NYHA Class 4 = 36 Other exclusion criteria n=27 • Language n=10 • Living in nursing home n=6 • Comorbidity n=4
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Assessed for eligibility n=250
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Eligible n=144
an
us
Declined n=69 Reason: location of classes n=46 Unable to contact n=18
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Randomized n=75
te
d
Assigned to Intervention group
Ac ce p
1Month N=35 Completed intervention (n=35) Attrition n=3 Reasons: transportation
3Month N=29 Attrition: N=6 Reason: Unable to contact n=5
Analyzed n=29
Assigned to control group
1Month N=34 Attrition: N=3 Reason: Unable to contact n=1
3Month N=27 Attrition: N=7 Reason: Unable to contact
Analyzed n=27
Figure 2. Consolidated Standards of Reporting Trials (CONSORT) diagram of the pilot study.
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Figure 3
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an
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34
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S0738-3991(14)00179-7 http://dx.doi.org/doi:10.1016/j.pec.2014.04.018 PEC 4780
To appear in:
Patient Education and Counseling
Received date: Revised date: Accepted date:
11-1-2014 19-4-2014 28-4-2014
Please cite this article as: Dickson VV, Melkus GDE, Katz S, Levine-Wong A, Dillworth J, Cleland CM, Riegel B, Building Skill in Heart Failure Self-Care among Community Dwelling Older Adults: Results of a Pilot Study, Patient Education and Counseling (2014), http://dx.doi.org/10.1016/j.pec.2014.04.018 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.
1
Building Skill in Heart Failure Self-Care among Community Dwelling Older Adults:
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Victoria Vaughan Dickson, PhD College of Nursing, New York University New York, USA
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Results of a Pilot Study
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Gail D’Eramo Melkus, EdD College of Nursing, New York University New York, USA
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Stuart Katz, MD School of Medicine, New York University New York, USA
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Alissa Levine-Wong, BS, BA, RN College of Nursing, New York University New York, USA
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d
Judy Dillworth, MS, BS, RN College of Nursing, New York University New York, USA
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Charles M. Cleland, PhD College of Nursing, New York University New York, USA
Barbara Riegel, DNSc School of Nursing, University of Pennsylvania Philadelphia, USA
Corresponding Author at Victoria Vaughan Dickson, PhD, CRNP College of Nursing New York University 726 Broadway,10th Floor New York, NY, USA 10003 Phone: 212-992-9426 Fax: 212-995-4564 Email: [email protected]
Page 1 of 35
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Abstract Objective: Most of the day-to-day care for heart failure (HF) is done by the patient at home and
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requires skill in self-care. In this randomized controlled trial (RCT) we tested the efficacy of a community-based skill-building intervention on HF self-care, knowledge and health-related
cr
quality of life (HRQL) at 1-and 3-months.
us
Methods: An ethnically diverse sample (n=75) of patients with HF (53% female; 32% Hispanic, 27% Black; mean age 69.9±10 years) was randomized to the intervention group (IG) or a wait-
an
list control group (CG). The protocol intervention focused on tactical and situational HF self-care skill development delivered by lay health educators in community senior centers. Data were
M
analyzed using mixed (between-within subjects) ANOVA.
Results: There was a significant improvement in self-care maintenance [F(2,47) =3.42, p=.04,
d
(Cohen’s f =.38)], self-care management [F(2,41) =4.10, p=.02, (Cohen’s f =.45) and HF
te
knowledge [F (2,53) =8.00, p=.001 (Cohen’s f =.54)] in the IG compared to the CG.
Ac ce p
Conclusions: The skill-building intervention improved self-care and knowledge but not HRQL in this community-dwelling sample.
Practice implications: Delivering an intervention in a community setting using lay health educators provides an alternative to clinic- or home-based teaching that may be useful across diverse populations and geographically varied settings.
Key Words: Heart failure, Self-care, treatment adherence, symptom monitoring decision-making, health educators Acknowledgements: This study was funded by the American Heart Association Clinical Research Program Grant: 10CRP4140049, PI: VV Dickson.
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Introduction
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Heart failure (HF) is a global epidemic affecting over 23 million people worldwide[1]with an associated economic burden estimated at more than $108 billion per
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year.[2] Despite advances in HF treatment, outcomes remain dismal with significant symptom
us
burden, low functional capacity, poor health-related quality of life (HRQL),[3, 4] frequent hospitalizations,[5] and early mortality.[6]
an
Even with innovations in technology, most of the day-to-day care for HF is done by the patient at home[7] and involves self-care. Self-care is defined as a naturalistic decision-making
M
process that includes self-care maintenance, those behaviors performed to maintain physiological stability (e.g., treatment adherence, symptom monitoring) and self-care management, which is
d
the response to HF symptoms when they occur.[8] Patients who engage in self-care have fewer
te
symptoms, better functional capabilities and better HRQL.[5] Conversely, as many as 50% of HF
10]
Ac ce p
patients are readmitted within three to six months of a hospital discharge due to poor self-care.[9,
International HF practice guidelines[11, 12] specify the need for HF self-care education. Despite more than a decade of self-care intervention research, self-care in the HF population remains very poor.[13, 14] One promising approach is disease management, a system of coordinated healthcare interventions and services often incorporating telemonitoring.[15] Yet, even these intense interventions have a significant rate of failure, with many patients readmitted for acute shortness of breath or large weight gains attributed to poor HF self-care.[16, 17]
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Other traditional methods of self-care education usually involve a didactic process focused primarily on improving knowledge about HF and self-care practices. This education usually
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takes place in a clinical setting with limited consideration of the sociocultural factors that influence self-care.[18] Studies have shown that knowledge, which refers to learning concepts or
cr
information[19] is necessary for effective self-care, but not sufficient to improve behavior.[20]
us
Adequate self-care requires skill in performing routine behaviors as well as skill in making decisions about signs and symptoms.[21] Skill refers to the ability to use information and apply it
an
in a context,[19] i.e., carry out a task with a pre-determined result. In HF, self-care skill evolves over time and with practice as patients learn how to make self-care practices fit into their daily
M
lives and as they gain experience in successfully managing symptoms. 1.1 Conceptual Model
d
This study is guided by the situation-specific theory of HF self-care.[22] Accordingly, self-
te
care is a naturalistic decision-making process in which persons engage for the purpose of
Ac ce p
maintaining health and managing their illness. This framework explains that in real world settings people make decisions that are meaningful and familiar to them.[23] Real life decisions are influenced by the interaction between the individual, the problem, and the current setting or environment.[22] Self-care decisions, for example, on whether to take medication or act early on symptoms, are situation and context specific, influenced by a person’s knowledge about and experience with decision making in the particular context, skill, and the compatibility of the decision and action with their values (figure 1). Guided by this theoretical framework, an intervention to improve self-care must not only increase knowledge about HF self-care, but also build skill in all aspects of self-care including unique situations. An intervention that is not consistent with one’s values, which are shaped by
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sociocultural factors, will not be used consistently over time.[22] Individuals who have the requisite knowledge, skills and experience are more likely to make an effective self-care decision.
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In turn, the outcomes of that self-care decision, (e.g., medication adherence, effective management of symptoms) will manifest as fewer symptoms, increased functional capacity and
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improved quality of life. These successful outcomes serve to reinforce future decision-making
us
about self-care. 1.2 Objectives
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The primary purpose of this study was to pilot test an innovative skill-building intervention to improve HF self-care among community-dwelling older adults. Specifically, the aims of this
M
randomized controlled trial (RCT) were to test efficacy of this theoretically-derived intervention at 1 and 3 months. We tested three hypotheses comparing 75 older adults with HF randomly
d
assigned to an intervention (IG) or a wait-list control group (CG):
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Hypothesis 1. Participants in the IG will have significantly improved HF self-care than CG.
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Hypothesis 2. Participants in the IG will have significantly improved knowledge about HF and HF self-care than CG
Hypothesis 3. Participants in the IG will have significantly better HRQL than CG. 2. Methods
2.1 Study Design
The complete methods of this study have been described elsewhere.[24] Briefly, to achieve the aims of the study, we employed a staggered randomized controlled design in which individuals were randomized to the intervention (IG) or to a wait-list control group (CG) that was offered the intervention after 3 months. Individuals randomized to the intervention arm participated in a group-based self-care intervention focused on building skill in essential self-care
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maintenance behaviors (e.g., following a low salt diet) and effective self-care management (e.g., symptom recognition).[21] The intervention was delivered by a trained health educator and was
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held in 3 community senior centers serving an urban, diverse, ethnic minority and low socioeconomic (SES) population.[24]
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2.2 Participants
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A convenience sample of older adults with HF was recruited from cardiology clinics and community settings in the northeastern US geographical area surrounding the clinical sites.
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Recruitment strategies included informational fliers posted in community settings (e.g., senior centers) and referrals by clinical providers familiar with the study. Individuals were
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eligible to participate if they had a diagnosis of chronic HF for at least 3 months,[25] were able to read and speak English or Spanish, were over age 55, and were living in a setting where they
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were able to engage in self-care (e.g., not in a long term care setting). Individuals were excluded
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if they had a cognitive impairment significant enough to interfere with study participation, as
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screened by administration of the Clock Drawing Test[26]. All participants provided written informed consent. The study protocol was approved by the appropriate university and clinical Institutional Review Boards.
The study was designed to have at least 80% power (alpha =.05) to detect a significant difference between the intervention and control group[27] assuming a 20% attrition rate. Thus, 75 participants were required to result in a final sample size of 60 (30 per group). A total of 250 individuals with HF were assessed for eligibility; 144 met the inclusion criteria and were approached for participation. Of those, 75 individuals were subsequently enrolled and randomized in the trial to the IG (n=38) or to the CG (n=37) (figure 2). Fifty-six individuals provided data for analysis in this study. The major reason for attrition across both the IG
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(n=5) and the CG (n=8) was inability to contact individuals for follow up. Other reasons included changes in personal status (e.g., transportation issues, non-HF related health
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issues) that prevented individuals from participating. In this study covariate adaptive randomization was used to achieve balance for
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treatment assignment within specific strata (i.e., gender, race, financial status). The PI used
and control for extraneous sources of variation.[29]
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2.3 Intervention
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Minim,[28] a software program to randomly assign participants to either the IG or the CG
The essential elements of the self-care skill building intervention are based on our prior work
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that adequate self-care requires skill in the daily behaviors related to self-care maintenance (e.g., adherence to a low salt diet, complex medication regimens, symptom monitoring) and skill in
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making decisions about signs and symptoms (e.g., diuretic titration).[21] The theoretically-
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based intervention[24] was designed to be delivered in a group setting by a lay health educator.
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This model leveraged the unique role of health educators who have a baccalaureate degree and credentialing in health education,[30] to promote skill-building in self-care using a well-defined protocol, provide reinforcement of the clinical plan of care and additional lifestyle coaching related to HF self-care, and facilitate problem solving including access to care.[31] Briefly, the skill building self-care intervention began with an assessment of each individual’s current knowledge of HF, level of tactical skill (e.g., low salt meal preparation), and any specific situations (e.g., cultural and social norms) that needed to be considered in building these skills. Skill-building exercises focused on skill deficits (e.g., how to read food labels) and managing common as well as unique situations (e.g., ordering food when eating out, managing diuretics while traveling) through practice and role-playing exercises.
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The intervention was delivered in a group setting of 4-8 participants and held in a community senior center. Twice weekly 60 minute sessions were provided over the course of 4
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weeks, led by a health educator who had received training in the protocol from the Principal Investigator. Content of the sessions focused on 4 major areas of the self-care process: 1)
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medication adherence, 2) low-salt diet, 3) symptom monitoring, and 4) symptom management.
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The intervention was offered in English and Spanish, the latter by a bilingual health educator. To ensure treatment fidelity, all intervention sessions were audiotaped and transcribed
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verbatim. Each transcription was reviewed using a performance criteria checklist to score the health educator’s adherence to the study protocol. In addition, the health educator kept notes for
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each session and debriefed weekly with the research team. Using this treatment fidelity method we ensured that the intervention was delivered as intended. Indeed, there was 94% adherence to
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the protocol by the health educators during the study period.[32]
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Individuals who were randomized to the wait-list CG received usual care that included any
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standard patient education information provided by their healthcare providers. After the last data collection point, they were offered enrollment into the intervention. Of the 37 who were initially randomized to the CG, 15 (40%) voluntarily went on to attend the intervention sessions. 2.4 Procedures
Data collection took place at baseline, 1 month and 3 months. At baseline, sociodemographic characteristics (e.g., age, gender, ethnicity, education), length of HF diagnosis, and medications were obtained by self-report. Valid and reliable instruments, described further below, were used to collect data on New York Heart Association (NYHA) class, co-morbid conditions and physical functioning in order to describe the sample. The major outcomes of self-care, knowledge and HRQL were collected at baseline and at 1- and 3-months.
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2.5 Outcome Variables Self-Care was measured using the Self-Care of Heart Failure Index (SCHFIV6.2)[27], 22
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items evaluated on a 4-point response scale. The SCHFI self-care maintenance scale, which reflects treatment adherence and monitoring and the self-care management scale, which
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measures response to symptoms when they occur, were used in this study. The SCHFI has been
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shown to be sensitive to subtle behavioral changes in a variety of HF samples. In this study the alpha coefficients were .60 and .65 respectively, values consistent with other studies.[33]
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Knowledge of HF was assessed using the Dutch HF Knowledge Scale (DHFKS).[34] The scale consists of items concerning HF knowledge in general, knowledge of HF treatment and HF
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symptoms. The content of the items is based on established patient education guidelines. In this study the alpha coefficient was .64, similar to reliability reported by the test developers.
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Health-related quality of life (HRQL), defined as a subjective sense of well-being
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encompassing physical, psychological, social, and spiritual dimensions related to health and
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healthcare[35] was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ).[36] The KCCQ is a 23-item questionnaire that quantifies disease-specific physical limitation, symptom frequency, severity, and change over time, overall quality of life, social interference, and self-efficacy—those dimensions shown to be key aspects of HRQL in persons with HF. In this study the alpha coefficients were adequate (range .72 to .92) and similar to the internal consistencies reported in another sample of people with HF.[36] The analysis in this study used the clinical summary scale score, which is comprised of the physical limitations and symptomrelated domains and the overall summary score. In addition to the outcome variables, clinical characteristics pertinent to HF self-care were collected using valid and reliable instruments. NYHA classification was assigned by a single
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cardiovascular nurse blinded to study participant status using a standardized questionnaire.[37] Comorbidity was measured using the interview format of the Charlson Comorbidity Index
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(CCI)[38] and responses were categorized into low, moderate, or high according to published methods.[39] Physical functioning was assessed by the Duke Activity Status Index (DASI). The
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DASI measures the individual’s ability to perform a range of specific daily activities and has
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adequate correlation with functional capacity measures.[40] In this study the Cronbach’s alpha was .78.
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2.6 Data Analysis
Descriptive statistics were used to describe baseline sociodemographic and clinical
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characteristics and outcomes (self-care, knowledge and HRQL). Chi-square and independent samples t-tests were used to examine differences at baseline based on group assignment.
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Changes in self-care, knowledge and HRQL were analyzed at 1-month and at 3-months. To test
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the three hypotheses regarding the effect of the intervention on improving HF self-care,
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knowledge and HRQL at 1-month and 3-months, a mixed model (between and within subject) analysis of variance (ANOVA) was conducted. Participant scores on the SCHFI (self-care maintenance and self-care management scales), DHFKS (knowledge) and the KCCQ (HRQL clinical summary and overall summary scores), were assessed across three time periods (baseline, 1-month and 3-months). In addition, the interaction between treatment (between-subjects factor) and time (within-subjects factor) on measures of self-care, knowledge and HRQL was assessed. Finally, Cohen’s f was calculated as a standardized index of effect sizes. Analyses were conducted using IBM SPSS v. 21.0 (Chicago, IL). An intention-to-treat analysis was performed. 3. Results 3.1 Participant Characteristics
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Table 1 presents the sociodemographic and clinical characteristics of the sample. The sample (53% female, mean age 69.9±10 years) was comprised mostly of ethnic minority adults (32%
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Hispanic, 27% Black, 14% other non-white). Most in this sample lived alone (58%) and 44% reported insufficient financial income. Seventy percent were in NYHA class II (mildly
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symptomatic) with at least 3 chronic conditions. The IG was slightly older than the CG (72±10.4
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years vs. 67± 9.4years, p=.05) but the CG reported more comorbid conditions (p=.001) and overall poorer perceived health status (p=.02). The CG also reported poorer physical functioning
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as measured by the DASI than the IG (13.8±10 compared to 20.6±14, p=.04). At baseline, there were no significant differences in self-care maintenance, self-care
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management or knowledge scores between the two groups. However, HRQL was significantly higher in the IG than the CG (KCCQ clinical summary score: 82.9±17 vs. 69.1±23, p = .01;
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KCCQ overall summary score: 80.1±17 vs. 66.2±24, p = .01) (shown in Table 2).
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Seventy-five percent (n=56) completed the 3-month assessment with no differences between
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completers and noncompleters in baseline sociodemographic or clinical characteristics. A total of 34 (90%) of individuals randomly assigned to the IG completed the first class with the health educator and a mean of 5.7± 0.5 classes of the 8 sessions offered. 3.2 Outcomes
As shown in table 2, two of our hypotheses were supported. Participants in the IG had improved self-care (hypothesis 1) and knowledge (hypothesis 2) but not HRQL (hypothesis 3). Figure 3 shows the estimated marginal means for self-care maintenance (3A), self-care management (3B) and knowledge (3C) for each group at each point in time. 3.2.1 Self-Care Maintenance
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Self-care maintenance improved in the IG compared to the CG. There was a significant interaction between the group and time, F(2, 47)=3.42, p=.041, (partial eta squared =.13)
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(figure 3A) suggesting effectiveness of the intervention in improving self-care maintenance. The interaction effect size was moderate (Cohen’s f = .38).
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3.2.2 Self-Care Management
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There was also significant improvement in self-care management in the IG but not the CG over the 3 month study period, with a significant interaction effect, F (2,41) =4.10,
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p= .024, (partial eta squared = .17) (figure 3B). The interaction effect size was large (Cohen’s f = .45).
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3.2.3 Knowledge
Similar results were seen in the third outcome of knowledge and suggest the
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effectiveness of the intervention in improving knowledge. There was a significant
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interaction effect, F (2, 53) =8.00, p= .001, (partial eta squared = .23) (figure 3C). The
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interaction effect size was large (Cohen’s f = .54). 3.2.4 HRQL
There was no significant difference in HRQL between the IG and the CG. There was a significant main effect of group in the KCCQ clinical summary score, F (1,36)=4.11, p=.05 and the overall summary score F(1,36) =4.66, p=.04 but no interaction effect in either measure of HRQL. That is, both groups improved over time suggesting no significant effect of the intervention on HRQL. 3.2.5 Adjustments for Baseline Differences in Participant Characteristics Additional analysis was conducted to take into account baseline differences in age, perceived health, comorbidity and physical functioning. Age, comorbidity and physical
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functioning were weakly and not significantly correlated with the dependent variables. Perceived health was significantly correlated with self-care maintenance (r=.328, p<.05)
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and HRQL (r=.451, p<.01). When perceived health was added as a covariate to an adjusted model described in Sections 3.2.1-3.2.4 above, conclusions drawn were no different than for
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the unadjusted analysis.
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4. Discussion and Conclusions
To our knowledge, this is the first study to describe the effects of a community-based skill
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building intervention in community dwelling ethnically diverse patients with HF. The intervention improved the essential behaviors of self-care maintenance and management as well
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as knowledge about HF. These results are consistent with prior reports of community-based interventions in non-HF chronic disease populations.[41-43] For example, Glazer et al’s
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systematic review reported that utilizing a community-based group setting for diabetes self-care
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resulted in improved meal planning, symptom monitoring and symptom management and
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promoted lasting changes in lifestyle behaviors,[41] which are similar to the self-care requirements of HF. Sustainability of behavior change in patients with diabetes was attributed to the social support network that evolved over time during the intervention. Similarly, our results of improved self-care at 1-month suggest the effectiveness of the group environment that allowed for ongoing support and dialogue with experts and peers. Therefore, we are optimistic that the significantly better self-care results at 3-months in the intervention group reflect the potential for sustainability of the intervention, but a longer follow up period is necessary to capture the lasting effects. Our study also showed an improvement in knowledge that has been frequently reported.[4446] However, our findings of improved self-care in addition to knowledge are noteworthy and
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strengthen the evidence for effectiveness of the intervention overall. Recently, Davis et al. reported improved knowledge but not self-care in their intervention trial, which reinforced
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that knowledge alone is not sufficient to improve self-care.[46] They concluded that individuals may not have been able to translate knowledge into self-care behaviors and offered
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the explanation that their intervention did not address the confidence or self-efficacy that is
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necessary for self-care. Our intervention that specifically focused on skill-building addresses the gap between knowledge and self-care. Intervention components like role-playing and
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reinforcement through practice exercises as used in our intervention[24] help people translate the content into practice. These methods are also known to promote self-efficacy,[47] and thus may
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have contributed to the positive results in self-care maintenance and management compared to others.
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Our intervention did not appear to have any effect on HRQL as measured by the clinical
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summary and overall summary score of the KCCQ. The current literature is equivocal on the
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effect of self-care interventions on HRQL. Many interventions are tested on patients after a clinical event such as a hospitalization.[48, 49] Literature reviews describing short term effects of various interventions on HRQL have suggested that the initial uptick in HRQL is related to the post discharge transition rather than the self-care intervention. It may be that since our sample was a clinically stable, community-dwelling population and recruited from the community and outpatient settings, rather than after a clinical event, we did not see an improvement in HRQL. Others have suggested that self-care is burdensome.[50] So it may be that the lack of any significant change in HRQL reflects the work of engaging in self-care more routinely.[51] A longer intervention may be needed to reinforce the self-care behaviors and demonstrate an improvement in HRQL[52] in those who may feel otherwise burdened over time.
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Another novel aspect of our intervention is the use of the health educator. Previous studies have demonstrated efficacy of chronic disease interventions implemented by health educators or
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community health workers (CHW),[53] but not in HF, to date. Notably, in the COACH trial, a comprehensive management intervention that tested a nurse practitioner/CHW collaboration
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compared to enhanced usual care, Allen et al (2011) reported significant results in cardiac risk
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reduction in the intervention group.[54] Others also have reported effective use of health educators to deliver health programs especially in underserved, low-socioeconomic, minority
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populations with chronic diseases such as hypertension, diabetes, HIV, and asthma.[53, 55-57] The role of the health educator in our study was similar in that health educators were trained in
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the use of a well-developed intervention protocol and focused on self-care, provided reinforcement of the self-care components of the clinical plan of care and facilitated problem
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solving with program participants. Our results, therefore, suggest that the health educator model
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may be an alternative to clinician-based approaches, especially when the focus of the
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intervention is on promoting self-care. 4.1 Limitations
The small sample size limited the ability to conduct subgroup analysis, for example, by NYHA class or race. The randomization procedure in this study was deterministic[58] and achieved covariate balance as intended, but the sample size was insufficient to achieve balance in age, comorbidity, physical functioning and perceived health. In the future, a larger RCT using randomization procedures that balance the group assignment is warranted. The study is also limited by the attrition rate. Several substantial weather events in the geographical region (e.g. superstorm Sandy) that occurred during the period of the study (2010-2012) made contacting participants difficult, thereby interrupting the
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enrollment process and data collection, and resulting in missing data for the 3-month follow-up. We also acknowledge that the urban community settings used in this study may be
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unique and may not reflect the ethnic minority and low SES population at large. Another limitation is the lack of a cost-effectiveness analysis.[59] Since patients with HF experience
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high symptom burden and exorbitant healthcare costs, understanding how this
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intervention might decrease health care costs is needed.
Despite these limitations, the study had numerous strengths including the ethnically
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diverse sample and strong treatment fidelity monitoring that support the results. This study provides important preliminary evidence of effectiveness of a community-based program for HF
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self-care and is a necessary step in the clinical translation of the intervention for use in other
4.2 Conclusions
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geographically diverse populations..
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To date, most HF self-care interventions have focused on reacting to an adverse event such as
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a hospitalization or emergency room visit and providing educational content to improve knowledge about HF and self-care. Disease management programs highlight clinical management during transition periods. The results of these approaches have been mixed and often not sustained,[49, 60] perhaps because they fall short in preparing patients to engage in self-care within the context of their daily lives and community resources. Improving self-care among ethnic minority patients with HF has been notoriously challenging. This study provides preliminary evidence of the efficacy of a community-based skill building self-care intervention delivered by health educators. The promising results suggest that focusing on the development of essential tactical and situational skills in self-care maintenance and management may help sustain effective self-care.
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4.3 Practice implications The results of this RCT suggest a shift in the paradigm of HF self-care interventions from
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reactive (e.g., to a clinical event) to the proactive engagement of community-dwelling adults in an intervention that will improve and sustain self-care among diverse populations with HF. The
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skill-building approach was effective in improving self-care maintenance and self-care
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management as well as knowledge. This study has important implications for the growing population of community-dwelling adults with HF because it leverages community resources.
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Providing the intervention in the community setting using trained health educators provides a practical solution that can be implemented across diverse populations and geographically varied
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settings.
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I confirm all patient/personal identifiers have been removed or disguised so the
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of the story.
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patient/person(s) described are not identifiable and cannot be identified through the details
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Legends
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Figure 1: Conceptual model of self-care as a naturalistic decision making process. Decisions are made about behaviors in which to engage and how to respond to symptoms when they occur.
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Self-care decisions are situation and context specific, influenced by a person’s knowledge about
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and experience with decision making in the particular context, skill to act on the decision made, and the compatibility of the decision and action with their values. Self-care decisions that lead to
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successful outcomes reinforce future decision-making about self-care.
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Figure 2: Consolidated Standards of Reporting Trials (CONSORT) diagram of the pilot study.
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Figure 3: Estimated Marginal Means for outcomes of self-care maintenance (3A), self-care
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management (3B) and knowledge (3C) by group and each time period.
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Table 1: Sociodemographic and clinical characteristics of sample Intervention
Control
(n=75)
(n=38)
(n=37)
69.9(10)
72(10.4)
35 (47%)
Female
40 (53%)
22 (58%)
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Ethnicity
16 (42%)
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Male
67(9.4)
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Gender
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Age, years
Total
.75 11 (30%)
Hispanic
24 (32%)
12 (32%)
12 (32%)
White
20 (27%)
12 (32%)
8 (22%)
Other
11 (14%)
5 (12%)
6 (16%)
13(3)
13.2(3.3)
12.7(3.4)
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9 (24%)
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.49
18 (48%)
20 (27%)
Marital Status
.05*
19 (52%)
Black
Education, years
P
.59 .26
Married
14(22%)
7 (19%)
7 (25%)
Widowed
15 (23%)
8 (22%)
7 (25%)
Divorced, separated, never
35(45%)
21 (58%)
14 (50%)
married
Living arrangements
.41
Lives alone
37 (58%)
23(62%)
14 (52%)
Lives with others
27 (42%)
14 (38%)
13 (48%)
Financial status Comfortable, more than enough
.62 14(19%)
8 (21%)
6 (16%)
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Enough to make ends meet 28 (37%)
14 (37%)
14 (37%)
33 (44%)
16 (42%)
17 (47%)
Over perceived health
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Not enough to make ends meet
Very good
13 (21%)
12 (32%)
Good
17 (27%)
9 (24%)
8 (29%)
Fair
28 (44%)
15 (41%)
15 (54%)
Poor
5 (8%)
1 (3%)
4 (14%)
7.5(7.1)
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NYHA Class
1 (4%)
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Length of HF diagnosis, years
7.4(7.4)
7.4(6.8)
27(66%)
18 (67%)
III
19 (30%)
10 (34%)
9 (33%)
2.8(1.5)
4.3(1.8)
Low
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Comorbidity category
d
45(70%)
3.4(1.8)
15 (41%)
6 (22%)
Med
25 (39%)
16 (43%)
9 (33%)
High
18 (28%)
6 (16%)
12 (44%)
17.5(13)
21.0(14)
13.3(11)
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.001** .06
21 (33%)
Physical functioning (DASI)
.98 .59
II
Comorbidity score
.02*
.02*
Data are presented as Mean( SD) or N (%) Abbreviations: ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotnesn receptor blocker; DASI, Duke Activity Status Index; HF, Heart Failure, ; NYHA, New York Heart Association;
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Table 2: Changes in Outcomes by Group and Over Time
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IG
CG M(SD)
Cohen’s f
P
M(SD)
30
SCHFI Self-Care Maintenance
. 63.9(15
1-month
)
3-months
75 (12)
58.5(18)
0
64.4(17)
4
64.5(16)
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Baseline
80.6(9)
.
45.8(24)
65.7(18
48.3(24)
)
0 2
49.4(21)
an
3-months
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1-month
43(21)
.45*
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SCHFI Self-Care Management Baseline
.38*
66.8(18
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) DHFKS Knowledge
10(3)
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3-months
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1-month
9.6(3)
0
13(2)
10(3)
0
12.7(1)
10.1(3)
1
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Baseline
.
KCCQ Clinical Summary
.
Score
Baseline
80.3(17 )
1-month
3-months
84.5(14
65.7(29)
9
69.8(31)
8
.54**
.03
70.3(30)
) 84.5(13 )
KCCQ Clinical Summary
.
Score Baseline 1-month 3-months
76(18)
63.6(28)
2
83.4(13
64.3(24)
2
)
66.5(23) 79.1(16
.20
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Data presented as Mean(standard deviation) P values are for the interaction effect (group x time)
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Key: CG: Control Group; DHFKS: Dutch Heart Failure Knowledge Scale, IG: Intervention
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Group; KCCQ: Kansas City Cardiomyopathy Questionnaire; SCHFI; Self-Care of Heart Failure Index
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Cohen’s f * = moderate effect size; **= large effect size
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Figure 1
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Figure 2 Excluded n= 106 Age n=43 NYHA Class 4 = 36 Other exclusion criteria n=27 • Language n=10 • Living in nursing home n=6 • Comorbidity n=4
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Assessed for eligibility n=250
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Eligible n=144
an
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Declined n=69 Reason: location of classes n=46 Unable to contact n=18
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Randomized n=75
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Assigned to Intervention group
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1Month N=35 Completed intervention (n=35) Attrition n=3 Reasons: transportation
3Month N=29 Attrition: N=6 Reason: Unable to contact n=5
Analyzed n=29
Assigned to control group
1Month N=34 Attrition: N=3 Reason: Unable to contact n=1
3Month N=27 Attrition: N=7 Reason: Unable to contact
Analyzed n=27
Figure 2. Consolidated Standards of Reporting Trials (CONSORT) diagram of the pilot study.
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Figure 3
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34
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