- Email: [email protected]
Empowerment of patients with end-stage renal disease—a randomized controlled trial
ARTICLE IN PRESS
International Journal of Nursing Studies 41 (2004) 59–65
Empowerment of patients with end-stage renal disease— a randomized controlled trial Shiow-Luan Tsaya,*, Li-Oer Hungb a
Graduate Institute of Nursing, National Taipei College of Nursing, 365 Ming Te Road, Pei-Tou, Taipei, Taiwan b Yuhing Nursing School, Kao-Shung, Taiwan Received 21 September 2002; received in revised form 23 May 2003; accepted 29 May 2003
Abstract The purpose of the study is to investigate the effectiveness of an empowerment program on empowerment level, selfcare self-efficacy and depression in patients with end-stage renal disease. The study was a randomized controlled trial; qualified patients in two dialysis centers of major hospitals in southern Taiwan were randomly assigned into an empowerment group (n ¼ 25) and a control group (n ¼ 25). The empowerment program included identification of problem areas for self-management; exploration of emotions associated with these problems; development of a set of goals and strategies to overcome these problems to achieve these goals; creation and implementation of behavioral change plans; and stress management. The outcomes measured were the Empowerment Scale, the Strategies Used by People to Promote Health and the Beck Depression Inventory. Data were collected at baseline and 6 weeks following intervention. Primary statistical analysis was by means of t-test and analysis of covariance. The results indicated that scores of the empowerment (t(48)=6.54, po0:001), self-care self-efficacy (F (1,47)=10.82, p ¼ 0:002) and depression (t(48)=2.49, p ¼ 0:03) in the empowerment group have a significantly greater improvement than the control group. r 2003 Elsevier Ltd. All rights reserved. Keywords: Empowerment; Self-care self-efficacy; Depression; ESRD
1. Introduction and literature review End-stage renal disease (ESRD) is a chronic illness. Ninety-five percent of those patients in Taiwan currently receive hemodialysis as a routine treatment of choice by health care professionals (Renal club, 2001). Patients with ESRD who receive complicated hemodialysis treatment also experience a wide range of multiple and radical lifestyle changes that affect individual’s social and psychological well-being. The treatment is a longterm process; patients have to manage their chronic illness in order to survive. These patients must frequently make daily decisions involving fluid intake, nutrition, physical activity, symptom management and *Corresponding author. Tel.: +886-2-2822-7101; fax: +8862-2828-0219. E-mail address: [email protected] (S.-L. Tsay).
dealing with stress. For many years, patient education has been focused on providing ESRD patients with the knowledge and skills to follow and comply with the treatment recommendations of health care professionals (Funnell and Anderson, 2000). However, there is a strong consensus that knowing what one should do for their illness does not necessary means that self-management behaviors will follow (Tsay and Healstead, 2002). Although successful self-management is the most important need for these ESRD patients, there are few documented interventional studies that have addressed this important question in an effort to facilitate patient’s self-care. Thus, there is a need to develop effective methods to assist patients in the self-management of ESRD. An empowerment program has been studied and offered as a valuable intervention in improving self-management of the diabetes population (Anderson et al., 1995). ESRD patients are also in great need for
0020-7489/03/$ - see front matter r 2003 Elsevier Ltd. All rights reserved. doi:10.1016/S0020-7489(03)00095-6
ARTICLE IN PRESS 60
S.-L. Tsay, L.-O. Hung / International Journal of Nursing Studies 41 (2004) 59–65
self-management of long-term illnesses. Therefore, the purpose of this study is to investigate the differences in empowerment, self-care self-efficacy and depression among those ESRD patients receiving usual care plus empowerment intervention and those receiving usual care. Traditional education for ESRD patients is designed and focused on providing the knowledge and skills to adhere to the treatment recommendations of health care professionals (Anderson and Funnell, 2000; Glasgow and Anderson, 1999). This approach assumes that education influences behavior, which subsequently influences self-management of patients. Extensive research has documented the ineffectiveness of this type of patient educational program in contributing significantly to lifestyle change or self-care behavior (Anderson and Funnell, 2000; Tsay and Healstead, 2002; Whittmore, 2000). Thus, patient education has gradually shifted from imparting knowledge to an interactive approach in ESRD care. This approach has changed from passive learning on the part of the patient to active participation in self-care and decision-making (Whittmore, 2000). Patient empowerment is one of those approaches to promote patients’ well-being in decision-making and self-management. The concept of empowerment begins with power. Power refers to the ability to influence what will happen to oneself. The exercise of empowerment is regarded as series of conscious acts within a therapy to help patients develop skills for independent problem solving, foster a sense of control and cultivate rational decision-making procedures during the process of selfcare (Anderson et al, 2000; Ellis-Stoll et al., 1998; Glasgow et al., 2001). A qualitative study of multiple sclerosis (MS) patients also supported that the elements for successful self-management of MS patients is the empowerment of patients (Luoto and Katajisto, 1998). Although empowerment related research in the ESRD population is limited, empowerment programs have been applied and with results which supported its effectiveness in the chronic illness populations. Anderson et al. (1995) utilized empowerment techniques for teaching diabetes patients self-management. They supported the use and effectiveness of the six 2-h weekly group sections of empowerment training in improving attitude, self-efficacy and a significant reduction in glycated hemoglobin levels in diabetes patients. Davison and Degner (1997) studied the effectiveness of an empowerment program for 60 men who were newly diagnosed with prostate cancer and found that the men in the intervention group assumed a significantly more active role in treatment decision making, had lower state anxiety levels at 6 weeks and with levels of depression not significantly changed. Pellino et al. (1998) conducted a study of empowerment education for a group of 74 orthopedic patients, and found that patients in the
intervention group significantly improved their selfefficacy in self-care. When patient empowerment programs strengthen their level of self-efficacy, patients are more confident in being able to perform relevant self-care behavior in the self-management of ESRD (Anderson, 1995). Selfcare self-efficacy is defined as a person’s confidence in being able to perform relevant self-care behaviors in a particular situation (Bandura, 1997; Lev and Owen, 1996). Increased self-efficacy is associated with increased compliance to treatment and changed behavior perceived as promoting physical and psychological wellbeing (Lev and Owen, 1998; Tsay and Healstead, 2002). In summary, ESRD affects the physical, social, emotional and cognitive aspects of a person’s life. Patient education requires a more comprehensive approach to encourage patients actively participate in their own self-management of long-term illness. Patient empowerment provides a model for intervention to facilitate in decision-making and self-care. Therefore, the goal of this study is to investigate the effects of a patient educational program in perceived empowerment, self-care self-efficacy and depression in a group of ESRD patients.
2. Methods 2.1. Subjects This prospective, randomized controlled trial with a pre-test, post-test design was carried out over a 9-month period. Eligible patients included those diagnosed with ESRD and treated with hemodialysis for at least 3 months, ages 18 and above, living in a home setting, able to read and write, and willing to participate. Subjects with an acute illness or hospitalized, and those who reported of psychiatric or cognitive disorders, or physical limitations in self-care were excluded. Fifty patients participated in the experiment (n ¼ 25) and control group (n ¼ 25). Power was estimated using Cohen’s table (Lipsey, 1990); significance level at 0.05, a large effect size, the power reached up to nearly 80%, which indicated adequacy of sample size for this study. 2.2. Experimental design and procedures The protocol received an institutional review board approval. The researcher and her assistant approached potential participants about the study in two dialysis centers affiliated with major hospitals. Potential subjects were screened first. After appropriate screening and consent to participate, subjects were assigned to either the experimental or control group based upon the SPSS statistical randomization software. Subjects in the experimental group received an information package
ARTICLE IN PRESS S.-L. Tsay, L.-O. Hung / International Journal of Nursing Studies 41 (2004) 59–65
with individual consulting sessions during the empowerment program three times a week for 4 weeks. A master’s degree holding nephrology clinical nurse specialist (CNS) conducted the individual consulting sessions. Subjects in the control group were given the information package and shown what it contained. Only the researcher and the CNS were aware of which treatment the patients were receiving. The patients’ usual caregivers (physicians, nurses, dieticians, and/or social workers) were uninformed as to the participants’ treatment group. The data was collected at baseline and 6 weeks following the intervention. The data collector was a trained research assistant who was left purposely unaware of a patient’s experimental or control group status to maintain double-blind accuracy. 2.3. Empowerment program The empowerment program for ESRD patients was developed based on the guidelines for facilitating a patient empowerment program (Arnold et al., 1995). The program is focused on helping patients develop skills and self-awareness in goal setting, problem solving, stress management, coping, social support and motivation. This behavioral change program included patient identification of problem areas for self-management of ESRD, the exploration of emotions associated with these problems, the development of a set of goals and strategies to overcome these problems to achieving these goals, and making behavioral change plan following by initiating self-care behaviors; and stress management. 2.4. Measures Empowerment was measured with the Empowerment Scale (ES) (Anderson et al., 2000). The scale was originally developed for measuring empowerment of diabetes patients. The ES is comprised of 28-items with 3 subscales and charts the management of the psychosocial aspects of the disease, assessment of dissatisfaction and readiness to change, and the setting and the achievement of goals. The internal consistency alpha ranged from 0.81 to 0.93. Validity of the scale was supported by factor analysis and concurrent correlation of the scale with attitude scales (Anderson et al., 2000). The scale items can also be applied to ESRD population. Therefore, the scale was modified by changing the word of diabetes to end-stage renal disease with dialysis treatment. The modified scale was assessed and demonstrated adequate content validity and internal consistency reliability (a ¼ 0:93) in this study. The strategies used by people to promote health (SUPPH) (Lev and Owen, 1996) was used to measure self-care self-efficacy. The scale contains 29 five-point adjective ratings and includes dimensions of coping,
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stress reduction, making decisions, and enjoyment of life. Subjects were asked to give responses ranging from little confidence (1) to quite a lot of confidence (5). The internal consistency reliability of the scale was 0.93. Construct validity and concurrent validity was reported to support the psychometric properties of the SUPPH created by the developers (Lev and Owen, 1996). In this study, the internal consistency alpha was 0.91. Depression is operationalized with the Beck Depression Inventory (BDI). The BDI (Beck et al., 1988) is a 21-item, four-point Likert-type scale on which participants note how much they have been bothered or distressed by problems and complaints during the past week, on scale from not at all (0) to extremely (4). Scores can range between normal (0–9) to severely depressed (30–63). Internal consistency alpha ranged from 0.79 to 0.93 across various samples. In the current study, the internal consistency was acceptable (standardized alpha 0.88). 2.5. Data analysis The data was analyzed with descriptive and inferential statistics using the SPSS statistical package. Statistics included frequency, percentage, mean, standard deviation, Pearson’s correlations, t-test and analysis of covariance.
3. Results 3.1. Patient characteristics The sample consisted of 50 hemodialysis patients (Table 1). The typical participants were 51.18 years old (SD=9.75), female (60%), married (90%), and employed (64%). Many had graduated from elementary school (36%) and high school (28%); and were religious (60%). The mean perceived renal disease severity was moderately severe (mean =6.74, SD=2.97, range=0–10), and the mean length of dialysis was 52.56 months (SD=36.51). There were no differences in clinical and demographic characteristics of the patients between the groups (p > 0:05). The data indicates homogeneity of subjects across the groups. 3.2. Description of studied variables The descriptive of studied variables at baseline and post-test are presented in Table 2. At baseline, subject reported moderate levels of empowerment, self-care selfefficacy and depression. The mean item ratings for empowerment (mean=3.49, SD=0.32, range=1–5) indicated that subjects were perceived to be moderately empowered in self-management of the ESRD. The item rating for self-care self-efficacy (mean=3.26, SD=0.50,
ARTICLE IN PRESS S.-L. Tsay, L.-O. Hung / International Journal of Nursing Studies 41 (2004) 59–65
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range=1–5) suggested that subjects were moderately confident of being able to perform self-care behavior related to the illness. The mean scores for depressive symptoms was a moderate 12.20 (SD=10.88). Continuing to the cutoff scores of BDI, 52% of the subjects were within normal range scores (scores 9 or below), 26% experienced mild depression, 14% moderate depression, and 8% severe depression. The correlations between outcome variables at baseline were investigated. Results demonstrated that Table 1 Demographic variables by group Variables
Empowerment (n ¼ 25)
Control (n ¼ 25)
n
%
n
%
9 16
36 64
11 14
44 56
6 6 8 5
24 24 32 20
12 4 6 3
48 16 24 12
Marital status Married 23 Single/divorced 2
92 8
22 3
88 12
Religious belief Yes No
13 12
52 48
15 10
60 40
Working Yes No
17 8
68 32
15 10
60 40
Gender Male Female Education Elementary Middle school High school College
a
w2
p
0.32
0.56
empowerment levels correlated positively with self-care self-efficacy (r ¼ 0:38; p ¼ 0:006) and negatively correlated with depression (r ¼ 0:30; p ¼ 0:03). Self-care self-efficacy was negatively correlated with depression (r ¼ 0:62; po0:001). Using a one-way ANOVA statistical method to compare mean differences on baseline data revealed no significant differences on the scores of empowerment, self-care self-efficacy and/or depression between groups (p > 0:05). These results further supported the homogeneity of the subjects between groups. The relationship between demographic and disease related variables and outcome variables of empowerment, self-care self-efficacy and depression were explored to identify covariates that might influence the effect of the empowerment intervention. Results demonstrated that there were no significant correlations identified (p > 0:05). Therefore, no demographic or disease-related variables were used as control variables in the following analyses for testing the effectiveness of empowerment intervention.
2.42a 0.12
3.3. Effect of intervention on empowerment scores
0.21a 0.64
0.32
0.57
0.34
0.56
Fisher’s exact test.
Prior to analysis of the effect of the empowerment intervention on empowerment scores using ANCOVA statistics, a preliminary analyses evaluation of the homogeneity-of-slopes assumption (F(1,46)=16.22, MSE=89.85, p0.002) demonstrated that the assumption was not be met. Therefore, change scores on empowerment between intervention and control groups were compared using a t-test. There was a significantly higher gain score in the intervention group using empowerment strategies than in the control group (t (48)=6.54, po0:001). The t-test was further applied to evaluate differences between groups on change scores in the subscales of empowerment. The t-tests were significant on all three subscales of the management of
Table 2 Description of studied variables in baseline and post-test between groups Variables
Experiment (n ¼ 25) Mean
Empowerment Baseline Post-test
Control (n ¼ 25) SD
Mean
Total (n ¼ 50) SD
Mean
SD
98.40 105.04
9.19 7.28
97.08 97.12
8.99 8.73
97.74 101.08
9.02 8.91
Self-care self-efficacy Baseline Post-test
89.56 96.00
14.88 13.55
93.00 91.40
13.62 10.55
91.28 93.70
14.02 12.24
Depression Baseline Post-test
14.00 13.36
11.31 10.55
10.40 10.40
10.34 10.34
12.20 11.88
10.88 10.45
ARTICLE IN PRESS S.-L. Tsay, L.-O. Hung / International Journal of Nursing Studies 41 (2004) 59–65 Table 3 Comparison of empowerment change scores between groups (N ¼ 50) Variable
Experiment group
Control group
t
p
Empowerment Psychosocial aspect Readiness to change Achieving goals
+6.64 +1.96 +2.88 +1.80
0.04 0.00 0.00 0.04
6.54 4.69 5.37 5.82
o001 o001 o001 o001
Change scores=post-test at 6 weeksbaseline.
the psychosocial aspects of the disease, assessment of dissatisfaction and readiness to change, and the setting and the achievement of goals as indicated in Table 3. 3.4. Effect of intervention on self-care self-efficacy The ANCOVA statistical method was applied to test for the effectiveness of the empowerment program on self-care self-efficacy. The pretest scores of the self-care self-efficacy were used as the covariance, and the posttest scores of the self-care self-efficacy were used as the dependent variable. An evaluation of the homogeneityof-slopes assumption indicated that the relationship between the covariance and the dependent variable did not differ significantly as a function of the independent variable, (F(1,46)=2.29, MSE=18.90, p0.25). The ANCOVA result was significant, F(1,47)=10.82, MSE=10.08, p ¼ 0:002; Z2 ¼ 0:19: The strength of relationship between the empowerment intervention and dependent variable of self-care self-efficacy was strong, as assessed by a partial Z2 : The means of the selfcare self-efficacy, which had been adjusted for initial differences, were ordered as expected across the groups. The intervention group had a larger adjusted mean (M ¼ 97:18), while the control group had a smaller adjusted mean (M ¼ 90:22). Higher scores indicated higher levels of self-care self-efficacy. 3.5. Effect of intervention on depression A t-test using change scores was conducted to test the effectiveness of the empowerment program on depression. The change scores for the experiment group was 0.64 and for the control group was 0.00. Result of the t-test was significant (t(48)=2.49, p ¼ 0:02) and indicated that subjects in the empowerment group were less depressed than the subjects in the control group.
4. Discussion This study found that there were significant differences in improvement of empowerment, self-care self-
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efficacy and depression in patients who were in the intervention group using empowerment strategies than with the control group patients. This difference in improvement may be mainly due to the effect of the individual empowerment consulting sessions. The results from this study suggest that empowerment techniques might have an important role for patients in selfmanagement of ESRD. These findings were similar to those reported in studies of diabetes patients (Anderson et al., 1995), prostate cancer patients (Davison and Degner, 1997) and orthopedic patients (Pellino et al., 1998). The empowerment education program in this study provided patients with the opportunity to reflect on their lives with ESRD and showed to be willing and able to set up appropriate goals and make decisions to care for their ESRD. Thus, patients in the program experienced feelings of a high level of empowerment for self-care selfefficacy. Additionally, patients were encouraged to explore their emotional responses, explore alternative ways of coping with stress and repeatedly practiced stress management skills during individual consulting sessions. As a result, patients were more able to deal with their illness related stress, thus suppressing their levels of depression to significantly lower levels than those patients in the control group. Patients who participated in the program significantly improved their level of self-care self-efficacy. When patients felt empowered, their self-efficacy was strengthened and thus, felt more confident in being able to perform relevant self-care behavior in the self-management regime needed for ESRD. Conger and Kanungo (1988) stated that the idea of empowerment was meant to enable, and implied a raised level of confidence to successfully execute desired behavior. This conceptual framing of empowerment strategies was also supported by a high correlation between perceived empowerment and self-care self-efficacy in this study (r ¼ 0:38; p ¼ 0:001). Thus, patients with high, positive attitudes toward self-care self-efficacy were more likely to carry out self-care regime that related to coping with illness, stress reduction, making decisions for their own care, and be able to enjoy life (Bandura, 1997; Clark and Dodge, 1999; Lev and Owen, 1996). The results of the study demonstrated that patients in the intervention group were significantly less depressed than patients in the control group. Previous research has also found that patients who are given the opportunity to participate in the healthcare decision-making process have a lower level of anxiety and depression compared patients who are not given a choice (Fallowfield et al., 1990). Patients in the empowerment group were encouraged to discuss their feelings and concerns with others and gain support from them. These patients may have then been able to obtain needed resources or support to manage ESRD related stress and confidence
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they needed to assume an active role in making ESRD care-related decisions. This statement is further supported by a significant negative correlation between empowerment and depression in this study (r ¼ 0:30; p ¼ 0:02). This study used a convenience sample of ESRD patients, but whose demographic characteristics were comparable with another study (Tsay and Healstead, 2002); nevertheless, these patients were willing to participate and able to engage in the empowerment program that emphasized a high degree of personal responsibility. The result of this study suggests that the empowerment program would benefit patients who are willing and able to engage in the program designed to change attitudes, self-care self-efficacy, and taking control in management of their ESRD. In summary, this study suggests that patient empowerment program is an effective intervention model to boost perceived levels of empowerment and self-care self-efficacy and to decrease level of depression that related to patients who have to live with ESRD. The major challenge in both research and clinical practice is to translate the short-term effects into long-term improvement in the self-management of illnesses and an improvement in the quality of life for ESRD patients who are routinely receiving hemodialysis treatment.
plications for ESRD patients who are on dialysis treatment. The findings suggest that assessment of ESRD patients’ empowerment quotient should be an essential part of nursing practice. Clinicians should consider providing empowerment therapies as an alternative method to improving dialysis patients’ self-care self-efficacy and mood. Nurses could be trained to consult with those who have a low empowerment level in the self-management of ESRD. This study provides a foundation for future studies of empowerment intervention for self-managing of ESRD patients. Others should replicate and expand the current study to address the research question using empowerment strategies to mitigate chronic maladies common to ESRD patients. This approach should be expanded to include a longitudinal design allow future researchers to state with more confidence that an empowerment program was responsible for improving self-care selfefficacy and depression management of ESRD patients.
Acknowledgements The authors would like to thank the National Science Counsel of Taiwan provided funding, NSC 91-2314-B227-004.
5. Limitations and implications The strengths of this study were (a) providing healthcare professionals with a research-based, noninvasive intervention program, and (b) demonstrating the efficiency an empowerment program to facilitate self-management of patients with ESRD. This study did not include a placebo group in the design to test the effectiveness of the empowerment program. Therefore, future researchers may opt to include a support group or a schedule of potential remedies in the design to control for possible placebo effects. The sample was drawn from the southern part of Taiwan. The generalizability of this finding to other samples of dialysis patients from other geographical areas cannot be ensured; however, our study was a randomized trial. The results also strongly supported the efficacy of the empowerment program as applied to self-care self-efficacy and depression. We feel that the findings from this study have potential for broad application outside of these two dialysis centers. One limitation of this study was the short follow up period after treatment. Therefore, the long-term effects of this empowerment have not been observed. Future research should include longitudinal studies with a cross over design to document the long time effects of the empowerment program for ESRD patients. The application of these research findings to promote patients’ self-management might have important im-
References Anderson, R.M., Funnell, M.M., 2000. Compliance and adherence are dysfunctional concepts in diabetes care. The Diabetes Educator 26 (4), 597–604. Anderson, R.M., Arnold, M.S., Funnell, M.M., Fitzgerald, J.T., Butler, P.M., Feste, C.C., 1995. The diabetes empowerment scale. Diabetes Care 23 (6), 739–743. Anderson, R.M., Fitzgerald, J.T., Funnell, M.M., Marrero, D.G., 2000. The diabetes empowerment scale. Diabetes Care 23 (6), 739–743. Arnold, M.S., Butler, P.M., Anderson, R.M., Funnell, M.M., 1995. Guidelines for facilitating a patient empowerment program. The Diabetes Educator 21 (4), 308–312. Bandura, A., 1997. Self-Efficacy: The Exercise of Control. Freeman, New York. Beck, A.T., Steer, R.A., Garbin, M.G., 1988. Psychometric properties of the beck depression inventory: twenty-five years of evaluation. Clinical Psychological Review 6, 77–100. Clark, N.M., Dodge, J.A., 1999. Exploring self-efficacy as a predictor of disease management. Health Education Behavior 26 (1), 72–89. Conger, J.A., Kanungo, R.N., 1988. The empowerment process: integrating theory and process. Academy of Management Review 13, 471–482. Davison, B.J., Degner, L.F., 1997. Empowerment of men newly diagnosed with prostate cancer. Cancer Nursing 20 (3), 187–196.
ARTICLE IN PRESS S.-L. Tsay, L.-O. Hung / International Journal of Nursing Studies 41 (2004) 59–65 Ellis-Stoll, C., Cynthia, C., Popkess-Vawter, S., 1998. A concept analysis on the process empowerment. Advances in Nursing Sciences 21 (2), 62–68. Fallowfield, L.J., Hall, A., Macgure, G.P., 1990. Psychological indicators of different treatment policies in women with early breast cancer outside a clinical trial. British Medical Journal 301, 575–580. Funnell, M.M., Anderson, R.M., 2000. The problem with compliance in diabetes. The Journal of the American Medical Association 284, 1709. Glasgow, R., Anderson, R.M., 1999. In diabetes care, moving from compliance to adherence is not enough: something entirely new is needed. Diabetes Care 22, 2090–2092. Glasgow, R.E., Hiss, R.G., Anderson, R.M., Friedman, N.M., Hayward, R.A., Marrero, D.G., 2001. Report of the health care delivery work group: behavioral research related to the establishment of a chronic disease model of diabetes care. Diabetes Care 24 (1), 124–130. Lev, E.L., Owen, S.V., 1996. A measurement of self-care selfefficacy. Research in Nursing & Health 19, 421–429.
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Lev, E.L., Owen, S.V., 1998. A prospective study of adjustment to hemodialysis. American Nephrology Nurses’ Association 25 (5), 495–503. Lipsey, M., 1990. Design Sensitivity: Statistical Power for Experimental Research. Sage, Newbury Park, CA. Luoto, E., Katajisto, J., 1998. Elements of empowerment and ms patients. Journal of Neuroscience Nursing 30 (2), 116–123. Pellino, T., Tluczek, A., Collins, M., Trimborn, S., Norwick, H., Engelke, Z.K., Broad, J., 1998. Increasing self-efficacy through empowerment: preoperative education for orthopedic patient. Orthopedic Nursing 17 (4), 54–59. Renal club 2001. Renal Club Statistics. Renal Club, Taipei. Tsay, S.L., Healstead, M., 2002. Self-care self-efficacy, depression, and quality of life among patients receiving hemodialysis in Taiwan. International Journal of Nursing Studies 39, 245–251. Whittmore, R., 2000. Strategies to facilitate lifestyle change associated with diabetes mellitus. Journal of Nursing Scholarship 32 (3), 225–232.
International Journal of Nursing Studies 41 (2004) 59–65
Empowerment of patients with end-stage renal disease— a randomized controlled trial Shiow-Luan Tsaya,*, Li-Oer Hungb a
Graduate Institute of Nursing, National Taipei College of Nursing, 365 Ming Te Road, Pei-Tou, Taipei, Taiwan b Yuhing Nursing School, Kao-Shung, Taiwan Received 21 September 2002; received in revised form 23 May 2003; accepted 29 May 2003
Abstract The purpose of the study is to investigate the effectiveness of an empowerment program on empowerment level, selfcare self-efficacy and depression in patients with end-stage renal disease. The study was a randomized controlled trial; qualified patients in two dialysis centers of major hospitals in southern Taiwan were randomly assigned into an empowerment group (n ¼ 25) and a control group (n ¼ 25). The empowerment program included identification of problem areas for self-management; exploration of emotions associated with these problems; development of a set of goals and strategies to overcome these problems to achieve these goals; creation and implementation of behavioral change plans; and stress management. The outcomes measured were the Empowerment Scale, the Strategies Used by People to Promote Health and the Beck Depression Inventory. Data were collected at baseline and 6 weeks following intervention. Primary statistical analysis was by means of t-test and analysis of covariance. The results indicated that scores of the empowerment (t(48)=6.54, po0:001), self-care self-efficacy (F (1,47)=10.82, p ¼ 0:002) and depression (t(48)=2.49, p ¼ 0:03) in the empowerment group have a significantly greater improvement than the control group. r 2003 Elsevier Ltd. All rights reserved. Keywords: Empowerment; Self-care self-efficacy; Depression; ESRD
1. Introduction and literature review End-stage renal disease (ESRD) is a chronic illness. Ninety-five percent of those patients in Taiwan currently receive hemodialysis as a routine treatment of choice by health care professionals (Renal club, 2001). Patients with ESRD who receive complicated hemodialysis treatment also experience a wide range of multiple and radical lifestyle changes that affect individual’s social and psychological well-being. The treatment is a longterm process; patients have to manage their chronic illness in order to survive. These patients must frequently make daily decisions involving fluid intake, nutrition, physical activity, symptom management and *Corresponding author. Tel.: +886-2-2822-7101; fax: +8862-2828-0219. E-mail address: [email protected] (S.-L. Tsay).
dealing with stress. For many years, patient education has been focused on providing ESRD patients with the knowledge and skills to follow and comply with the treatment recommendations of health care professionals (Funnell and Anderson, 2000). However, there is a strong consensus that knowing what one should do for their illness does not necessary means that self-management behaviors will follow (Tsay and Healstead, 2002). Although successful self-management is the most important need for these ESRD patients, there are few documented interventional studies that have addressed this important question in an effort to facilitate patient’s self-care. Thus, there is a need to develop effective methods to assist patients in the self-management of ESRD. An empowerment program has been studied and offered as a valuable intervention in improving self-management of the diabetes population (Anderson et al., 1995). ESRD patients are also in great need for
0020-7489/03/$ - see front matter r 2003 Elsevier Ltd. All rights reserved. doi:10.1016/S0020-7489(03)00095-6
ARTICLE IN PRESS 60
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self-management of long-term illnesses. Therefore, the purpose of this study is to investigate the differences in empowerment, self-care self-efficacy and depression among those ESRD patients receiving usual care plus empowerment intervention and those receiving usual care. Traditional education for ESRD patients is designed and focused on providing the knowledge and skills to adhere to the treatment recommendations of health care professionals (Anderson and Funnell, 2000; Glasgow and Anderson, 1999). This approach assumes that education influences behavior, which subsequently influences self-management of patients. Extensive research has documented the ineffectiveness of this type of patient educational program in contributing significantly to lifestyle change or self-care behavior (Anderson and Funnell, 2000; Tsay and Healstead, 2002; Whittmore, 2000). Thus, patient education has gradually shifted from imparting knowledge to an interactive approach in ESRD care. This approach has changed from passive learning on the part of the patient to active participation in self-care and decision-making (Whittmore, 2000). Patient empowerment is one of those approaches to promote patients’ well-being in decision-making and self-management. The concept of empowerment begins with power. Power refers to the ability to influence what will happen to oneself. The exercise of empowerment is regarded as series of conscious acts within a therapy to help patients develop skills for independent problem solving, foster a sense of control and cultivate rational decision-making procedures during the process of selfcare (Anderson et al, 2000; Ellis-Stoll et al., 1998; Glasgow et al., 2001). A qualitative study of multiple sclerosis (MS) patients also supported that the elements for successful self-management of MS patients is the empowerment of patients (Luoto and Katajisto, 1998). Although empowerment related research in the ESRD population is limited, empowerment programs have been applied and with results which supported its effectiveness in the chronic illness populations. Anderson et al. (1995) utilized empowerment techniques for teaching diabetes patients self-management. They supported the use and effectiveness of the six 2-h weekly group sections of empowerment training in improving attitude, self-efficacy and a significant reduction in glycated hemoglobin levels in diabetes patients. Davison and Degner (1997) studied the effectiveness of an empowerment program for 60 men who were newly diagnosed with prostate cancer and found that the men in the intervention group assumed a significantly more active role in treatment decision making, had lower state anxiety levels at 6 weeks and with levels of depression not significantly changed. Pellino et al. (1998) conducted a study of empowerment education for a group of 74 orthopedic patients, and found that patients in the
intervention group significantly improved their selfefficacy in self-care. When patient empowerment programs strengthen their level of self-efficacy, patients are more confident in being able to perform relevant self-care behavior in the self-management of ESRD (Anderson, 1995). Selfcare self-efficacy is defined as a person’s confidence in being able to perform relevant self-care behaviors in a particular situation (Bandura, 1997; Lev and Owen, 1996). Increased self-efficacy is associated with increased compliance to treatment and changed behavior perceived as promoting physical and psychological wellbeing (Lev and Owen, 1998; Tsay and Healstead, 2002). In summary, ESRD affects the physical, social, emotional and cognitive aspects of a person’s life. Patient education requires a more comprehensive approach to encourage patients actively participate in their own self-management of long-term illness. Patient empowerment provides a model for intervention to facilitate in decision-making and self-care. Therefore, the goal of this study is to investigate the effects of a patient educational program in perceived empowerment, self-care self-efficacy and depression in a group of ESRD patients.
2. Methods 2.1. Subjects This prospective, randomized controlled trial with a pre-test, post-test design was carried out over a 9-month period. Eligible patients included those diagnosed with ESRD and treated with hemodialysis for at least 3 months, ages 18 and above, living in a home setting, able to read and write, and willing to participate. Subjects with an acute illness or hospitalized, and those who reported of psychiatric or cognitive disorders, or physical limitations in self-care were excluded. Fifty patients participated in the experiment (n ¼ 25) and control group (n ¼ 25). Power was estimated using Cohen’s table (Lipsey, 1990); significance level at 0.05, a large effect size, the power reached up to nearly 80%, which indicated adequacy of sample size for this study. 2.2. Experimental design and procedures The protocol received an institutional review board approval. The researcher and her assistant approached potential participants about the study in two dialysis centers affiliated with major hospitals. Potential subjects were screened first. After appropriate screening and consent to participate, subjects were assigned to either the experimental or control group based upon the SPSS statistical randomization software. Subjects in the experimental group received an information package
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with individual consulting sessions during the empowerment program three times a week for 4 weeks. A master’s degree holding nephrology clinical nurse specialist (CNS) conducted the individual consulting sessions. Subjects in the control group were given the information package and shown what it contained. Only the researcher and the CNS were aware of which treatment the patients were receiving. The patients’ usual caregivers (physicians, nurses, dieticians, and/or social workers) were uninformed as to the participants’ treatment group. The data was collected at baseline and 6 weeks following the intervention. The data collector was a trained research assistant who was left purposely unaware of a patient’s experimental or control group status to maintain double-blind accuracy. 2.3. Empowerment program The empowerment program for ESRD patients was developed based on the guidelines for facilitating a patient empowerment program (Arnold et al., 1995). The program is focused on helping patients develop skills and self-awareness in goal setting, problem solving, stress management, coping, social support and motivation. This behavioral change program included patient identification of problem areas for self-management of ESRD, the exploration of emotions associated with these problems, the development of a set of goals and strategies to overcome these problems to achieving these goals, and making behavioral change plan following by initiating self-care behaviors; and stress management. 2.4. Measures Empowerment was measured with the Empowerment Scale (ES) (Anderson et al., 2000). The scale was originally developed for measuring empowerment of diabetes patients. The ES is comprised of 28-items with 3 subscales and charts the management of the psychosocial aspects of the disease, assessment of dissatisfaction and readiness to change, and the setting and the achievement of goals. The internal consistency alpha ranged from 0.81 to 0.93. Validity of the scale was supported by factor analysis and concurrent correlation of the scale with attitude scales (Anderson et al., 2000). The scale items can also be applied to ESRD population. Therefore, the scale was modified by changing the word of diabetes to end-stage renal disease with dialysis treatment. The modified scale was assessed and demonstrated adequate content validity and internal consistency reliability (a ¼ 0:93) in this study. The strategies used by people to promote health (SUPPH) (Lev and Owen, 1996) was used to measure self-care self-efficacy. The scale contains 29 five-point adjective ratings and includes dimensions of coping,
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stress reduction, making decisions, and enjoyment of life. Subjects were asked to give responses ranging from little confidence (1) to quite a lot of confidence (5). The internal consistency reliability of the scale was 0.93. Construct validity and concurrent validity was reported to support the psychometric properties of the SUPPH created by the developers (Lev and Owen, 1996). In this study, the internal consistency alpha was 0.91. Depression is operationalized with the Beck Depression Inventory (BDI). The BDI (Beck et al., 1988) is a 21-item, four-point Likert-type scale on which participants note how much they have been bothered or distressed by problems and complaints during the past week, on scale from not at all (0) to extremely (4). Scores can range between normal (0–9) to severely depressed (30–63). Internal consistency alpha ranged from 0.79 to 0.93 across various samples. In the current study, the internal consistency was acceptable (standardized alpha 0.88). 2.5. Data analysis The data was analyzed with descriptive and inferential statistics using the SPSS statistical package. Statistics included frequency, percentage, mean, standard deviation, Pearson’s correlations, t-test and analysis of covariance.
3. Results 3.1. Patient characteristics The sample consisted of 50 hemodialysis patients (Table 1). The typical participants were 51.18 years old (SD=9.75), female (60%), married (90%), and employed (64%). Many had graduated from elementary school (36%) and high school (28%); and were religious (60%). The mean perceived renal disease severity was moderately severe (mean =6.74, SD=2.97, range=0–10), and the mean length of dialysis was 52.56 months (SD=36.51). There were no differences in clinical and demographic characteristics of the patients between the groups (p > 0:05). The data indicates homogeneity of subjects across the groups. 3.2. Description of studied variables The descriptive of studied variables at baseline and post-test are presented in Table 2. At baseline, subject reported moderate levels of empowerment, self-care selfefficacy and depression. The mean item ratings for empowerment (mean=3.49, SD=0.32, range=1–5) indicated that subjects were perceived to be moderately empowered in self-management of the ESRD. The item rating for self-care self-efficacy (mean=3.26, SD=0.50,
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range=1–5) suggested that subjects were moderately confident of being able to perform self-care behavior related to the illness. The mean scores for depressive symptoms was a moderate 12.20 (SD=10.88). Continuing to the cutoff scores of BDI, 52% of the subjects were within normal range scores (scores 9 or below), 26% experienced mild depression, 14% moderate depression, and 8% severe depression. The correlations between outcome variables at baseline were investigated. Results demonstrated that Table 1 Demographic variables by group Variables
Empowerment (n ¼ 25)
Control (n ¼ 25)
n
%
n
%
9 16
36 64
11 14
44 56
6 6 8 5
24 24 32 20
12 4 6 3
48 16 24 12
Marital status Married 23 Single/divorced 2
92 8
22 3
88 12
Religious belief Yes No
13 12
52 48
15 10
60 40
Working Yes No
17 8
68 32
15 10
60 40
Gender Male Female Education Elementary Middle school High school College
a
w2
p
0.32
0.56
empowerment levels correlated positively with self-care self-efficacy (r ¼ 0:38; p ¼ 0:006) and negatively correlated with depression (r ¼ 0:30; p ¼ 0:03). Self-care self-efficacy was negatively correlated with depression (r ¼ 0:62; po0:001). Using a one-way ANOVA statistical method to compare mean differences on baseline data revealed no significant differences on the scores of empowerment, self-care self-efficacy and/or depression between groups (p > 0:05). These results further supported the homogeneity of the subjects between groups. The relationship between demographic and disease related variables and outcome variables of empowerment, self-care self-efficacy and depression were explored to identify covariates that might influence the effect of the empowerment intervention. Results demonstrated that there were no significant correlations identified (p > 0:05). Therefore, no demographic or disease-related variables were used as control variables in the following analyses for testing the effectiveness of empowerment intervention.
2.42a 0.12
3.3. Effect of intervention on empowerment scores
0.21a 0.64
0.32
0.57
0.34
0.56
Fisher’s exact test.
Prior to analysis of the effect of the empowerment intervention on empowerment scores using ANCOVA statistics, a preliminary analyses evaluation of the homogeneity-of-slopes assumption (F(1,46)=16.22, MSE=89.85, p0.002) demonstrated that the assumption was not be met. Therefore, change scores on empowerment between intervention and control groups were compared using a t-test. There was a significantly higher gain score in the intervention group using empowerment strategies than in the control group (t (48)=6.54, po0:001). The t-test was further applied to evaluate differences between groups on change scores in the subscales of empowerment. The t-tests were significant on all three subscales of the management of
Table 2 Description of studied variables in baseline and post-test between groups Variables
Experiment (n ¼ 25) Mean
Empowerment Baseline Post-test
Control (n ¼ 25) SD
Mean
Total (n ¼ 50) SD
Mean
SD
98.40 105.04
9.19 7.28
97.08 97.12
8.99 8.73
97.74 101.08
9.02 8.91
Self-care self-efficacy Baseline Post-test
89.56 96.00
14.88 13.55
93.00 91.40
13.62 10.55
91.28 93.70
14.02 12.24
Depression Baseline Post-test
14.00 13.36
11.31 10.55
10.40 10.40
10.34 10.34
12.20 11.88
10.88 10.45
ARTICLE IN PRESS S.-L. Tsay, L.-O. Hung / International Journal of Nursing Studies 41 (2004) 59–65 Table 3 Comparison of empowerment change scores between groups (N ¼ 50) Variable
Experiment group
Control group
t
p
Empowerment Psychosocial aspect Readiness to change Achieving goals
+6.64 +1.96 +2.88 +1.80
0.04 0.00 0.00 0.04
6.54 4.69 5.37 5.82
o001 o001 o001 o001
Change scores=post-test at 6 weeksbaseline.
the psychosocial aspects of the disease, assessment of dissatisfaction and readiness to change, and the setting and the achievement of goals as indicated in Table 3. 3.4. Effect of intervention on self-care self-efficacy The ANCOVA statistical method was applied to test for the effectiveness of the empowerment program on self-care self-efficacy. The pretest scores of the self-care self-efficacy were used as the covariance, and the posttest scores of the self-care self-efficacy were used as the dependent variable. An evaluation of the homogeneityof-slopes assumption indicated that the relationship between the covariance and the dependent variable did not differ significantly as a function of the independent variable, (F(1,46)=2.29, MSE=18.90, p0.25). The ANCOVA result was significant, F(1,47)=10.82, MSE=10.08, p ¼ 0:002; Z2 ¼ 0:19: The strength of relationship between the empowerment intervention and dependent variable of self-care self-efficacy was strong, as assessed by a partial Z2 : The means of the selfcare self-efficacy, which had been adjusted for initial differences, were ordered as expected across the groups. The intervention group had a larger adjusted mean (M ¼ 97:18), while the control group had a smaller adjusted mean (M ¼ 90:22). Higher scores indicated higher levels of self-care self-efficacy. 3.5. Effect of intervention on depression A t-test using change scores was conducted to test the effectiveness of the empowerment program on depression. The change scores for the experiment group was 0.64 and for the control group was 0.00. Result of the t-test was significant (t(48)=2.49, p ¼ 0:02) and indicated that subjects in the empowerment group were less depressed than the subjects in the control group.
4. Discussion This study found that there were significant differences in improvement of empowerment, self-care self-
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efficacy and depression in patients who were in the intervention group using empowerment strategies than with the control group patients. This difference in improvement may be mainly due to the effect of the individual empowerment consulting sessions. The results from this study suggest that empowerment techniques might have an important role for patients in selfmanagement of ESRD. These findings were similar to those reported in studies of diabetes patients (Anderson et al., 1995), prostate cancer patients (Davison and Degner, 1997) and orthopedic patients (Pellino et al., 1998). The empowerment education program in this study provided patients with the opportunity to reflect on their lives with ESRD and showed to be willing and able to set up appropriate goals and make decisions to care for their ESRD. Thus, patients in the program experienced feelings of a high level of empowerment for self-care selfefficacy. Additionally, patients were encouraged to explore their emotional responses, explore alternative ways of coping with stress and repeatedly practiced stress management skills during individual consulting sessions. As a result, patients were more able to deal with their illness related stress, thus suppressing their levels of depression to significantly lower levels than those patients in the control group. Patients who participated in the program significantly improved their level of self-care self-efficacy. When patients felt empowered, their self-efficacy was strengthened and thus, felt more confident in being able to perform relevant self-care behavior in the self-management regime needed for ESRD. Conger and Kanungo (1988) stated that the idea of empowerment was meant to enable, and implied a raised level of confidence to successfully execute desired behavior. This conceptual framing of empowerment strategies was also supported by a high correlation between perceived empowerment and self-care self-efficacy in this study (r ¼ 0:38; p ¼ 0:001). Thus, patients with high, positive attitudes toward self-care self-efficacy were more likely to carry out self-care regime that related to coping with illness, stress reduction, making decisions for their own care, and be able to enjoy life (Bandura, 1997; Clark and Dodge, 1999; Lev and Owen, 1996). The results of the study demonstrated that patients in the intervention group were significantly less depressed than patients in the control group. Previous research has also found that patients who are given the opportunity to participate in the healthcare decision-making process have a lower level of anxiety and depression compared patients who are not given a choice (Fallowfield et al., 1990). Patients in the empowerment group were encouraged to discuss their feelings and concerns with others and gain support from them. These patients may have then been able to obtain needed resources or support to manage ESRD related stress and confidence
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they needed to assume an active role in making ESRD care-related decisions. This statement is further supported by a significant negative correlation between empowerment and depression in this study (r ¼ 0:30; p ¼ 0:02). This study used a convenience sample of ESRD patients, but whose demographic characteristics were comparable with another study (Tsay and Healstead, 2002); nevertheless, these patients were willing to participate and able to engage in the empowerment program that emphasized a high degree of personal responsibility. The result of this study suggests that the empowerment program would benefit patients who are willing and able to engage in the program designed to change attitudes, self-care self-efficacy, and taking control in management of their ESRD. In summary, this study suggests that patient empowerment program is an effective intervention model to boost perceived levels of empowerment and self-care self-efficacy and to decrease level of depression that related to patients who have to live with ESRD. The major challenge in both research and clinical practice is to translate the short-term effects into long-term improvement in the self-management of illnesses and an improvement in the quality of life for ESRD patients who are routinely receiving hemodialysis treatment.
plications for ESRD patients who are on dialysis treatment. The findings suggest that assessment of ESRD patients’ empowerment quotient should be an essential part of nursing practice. Clinicians should consider providing empowerment therapies as an alternative method to improving dialysis patients’ self-care self-efficacy and mood. Nurses could be trained to consult with those who have a low empowerment level in the self-management of ESRD. This study provides a foundation for future studies of empowerment intervention for self-managing of ESRD patients. Others should replicate and expand the current study to address the research question using empowerment strategies to mitigate chronic maladies common to ESRD patients. This approach should be expanded to include a longitudinal design allow future researchers to state with more confidence that an empowerment program was responsible for improving self-care selfefficacy and depression management of ESRD patients.
Acknowledgements The authors would like to thank the National Science Counsel of Taiwan provided funding, NSC 91-2314-B227-004.
5. Limitations and implications The strengths of this study were (a) providing healthcare professionals with a research-based, noninvasive intervention program, and (b) demonstrating the efficiency an empowerment program to facilitate self-management of patients with ESRD. This study did not include a placebo group in the design to test the effectiveness of the empowerment program. Therefore, future researchers may opt to include a support group or a schedule of potential remedies in the design to control for possible placebo effects. The sample was drawn from the southern part of Taiwan. The generalizability of this finding to other samples of dialysis patients from other geographical areas cannot be ensured; however, our study was a randomized trial. The results also strongly supported the efficacy of the empowerment program as applied to self-care self-efficacy and depression. We feel that the findings from this study have potential for broad application outside of these two dialysis centers. One limitation of this study was the short follow up period after treatment. Therefore, the long-term effects of this empowerment have not been observed. Future research should include longitudinal studies with a cross over design to document the long time effects of the empowerment program for ESRD patients. The application of these research findings to promote patients’ self-management might have important im-
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