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The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation
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The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation Karin Menga,* ,1, Gunda Musekampa,1, Michael Schulera , Bettina Seekatza , Johannes Glatzb , Gabriele Kargerc , Ulrich Kiwusd , Ernst Knoglingere , Rainer Schubmannf , Ronja Westphalg , Hermann Fallera a
Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Wuerzburg, Würzburg, Germany Rehabilitation Center Seehof, Teltow, Berlin, Germany c Rehabilitation Hospital Heidelberg-Königstuhl, Heidelberg, Germany d Rehabilitation Center Bad Nauheim—Rehabilitation Hospital Wetterau, Bad Nauheim, Germany e Rehabilitation Hospital Kirchberg-Klinik, Bad Lauterberg, Germany f Rehabilitation Hospital Möhnesee, Möhnesee, Germany g Segeberger Kliniken GmbH, Rehabilitation Hospital, Bad Segeberg, Germany b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 20 November 2015 Received in revised form 27 January 2016 Accepted 13 February 2016
Objective: To evaluate a patient-centred self-management educational group program for patients with chronic systolic heart failure as compared to usual care education during inpatient cardiac rehabilitation. Methods: A multicentre cluster randomized controlled trial of 475 patients was conducted. In the intervention condition, patients received the new self-management educational group program whereas in the control condition, patients received a short lecture-based educational program (usual care). The primary outcome was patients‘ self-reported self-management competence. Secondary outcomes included self-management health behaviour, health-related quality of life, and treatment satisfaction. Patients completed self-reported outcome measures at admission, discharge, and after 6 and 12 months. Results: There was a significant small between-group intervention effect on certain dimension of patients’ self-management competence (self-monitoring and insight) in short term (p < 0.05). Furthermore, significant small effects were observed for treatment satisfaction at discharge as well as symptom monitoring after 6 months (p < 0.05) and by trend on symptom monitoring and physical activity after 12 months. Conclusions: The patient-centred self-management program might be more effective in certain selfmanagement outcomes than a usual care education in both short-term and long-term periods. Practice implications: Therefore, such programs may be considered for dissemination within cardiac rehabilitation. ã 2016 Elsevier Ireland Ltd. All rights reserved.
Keywords: Chronic heart failure Patient education Self-management Evaluation Cluster-RCT Cardiac rehabilitation
1. Introduction Chronic heart failure (HF) is a disease that requires a complex treatment regimen over a life-long period. Therefore, self-care/ self-management is an essential part of successful treatment in patients with HF [1,2]. There is evidence for the effectiveness of
* Corresponding author at: University of Wuerzburg, Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences Klinikstr. 3, D-97070 Würzburg, Germany. Fax: +49 931 31827130. E-mail address: [email protected] (K. Meng). 1 Both authors contributed equally to this work.
self-management interventions and patient education for HF patients regarding knowledge, self-efficacy, self-management behaviours, health-related quality of life, hospitalization and mortality [e.g., [3–5]]. However, studies show methodological shortcomings and further research is needed to determine independent effects of specific self-management interventions as well as different combinations of interventions [4]. For HF patients, essential educational topics that should be covered include pathophysiology and aetiology, symptoms and signs, pharmacological treatment, risk factor modification, diet and exercise, sexual activity, immunization, sleep and breathing disorders, adherence, psychosocial aspects and prognosis, each
http://dx.doi.org/10.1016/j.pec.2016.02.010 0738-3991/ ã 2016 Elsevier Ireland Ltd. All rights reserved.
Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010
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associated with certain skills or self-management behaviours [2]. Thus, the focus on knowledge and providing information only may not be sufficient, and guidelines recommend comprehensive HF education and counselling targeting skills and behaviour [1,2]. Effective means for delivery may include individualization of content, use of combined mediums, provision of education on a one-on-one basis, and in multiple sessions, but studies that describe group delivery are missing [6]. Thus, studies need to explore the effects of patient education programs provided in a group format, as well as effects of specific educational techniques and identify subgroups of patients who benefit most. Patient education is an essential part of cardiac rehabilitation [7] for HF in Germany. Nevertheless, at the time of the conception of our study no evaluated educational group programs for HFpatients had been available for routine use so far. Moreover, many German patient education programs still lack certain quality requirements, such as the use of manuals, patient-oriented didactics, small-group format and evaluation of effectiveness [8]. In addition, few studies have compared different educational approaches applied within a multidisciplinary rehabilitation program in an inpatient setting [e.g., [9,10]]. Therefore, this study evaluated the short-, intermediate- and long-term effects of a patient-centred self-management educational group program as compared with a usual care program for HF patients receiving inpatient cardiac rehabilitation. We hypothesized that the self-management education group program is superior to usual care regarding self-reported self-management competence (primary outcome). In addition, we expected superior
effectiveness of the new program regarding several self-management behaviours, as well as health-related quality of life (HRQL), and treatment satisfaction (secondary outcomes). 2. Methods 2.1. Design and procedure This study was a multicentre cluster randomized controlled trial (RCT; WHO International Clinical Trials: DRKS00004841) in four cardiac rehabilitation clinics in Germany. Clusters were patient education groups that comprise HF patients recruited within two weeks after commencement of inpatient rehabilitation. Clusters were randomly assigned to the two treatment groups using a computer-generated list of random numbers. Randomization was performed by a scientific assistant at the research institute (central randomization per phone or e-mail) guarantying allocation concealment until a complete cluster had been recruited. Eligibility criteria for participants were a diagnosis of chronic systolic heart failure (ICD-10: I50), left ventricular ejection fraction (LVEF) of 40, and New York Heart Association (NYHA) functional classification II or III. Exclusion criteria were acute events of decompensation, cognitive impairment, inadequate German language ability, and severe visual or hearing impairment. In the intervention group (IG), patients received the new patientcentred self-management educational program, whereas in the control group (CG), patients received a short lecture program (usual care). Data were assessed at admission (t1) and three
Enrolment
Assessed for eligibility/ contacted for participation (n = 580) Excluded Not eligible (n = 9) Refused to participate (n = 58)
Follow-Up
Allocation
Agreed to participate/allocated to cluster (n = 513) Cluster randomization
Control group (n = 245 patients; n = 43 clusters)
Intervention group (n = 268 patients; n = 45 clusters)
Did not complete questionnaire (n = 14); Attended no intervention (n = 4)
Did not complete questionnaire (n = 7); Attended no intervention (n = 12); Met exclusion criterion (n = 1)
Received allocated intervention/ completed assessment t1 (n = 227)
Received allocated intervention/ completed assessment t1 (n = 248)
Follow-up assessment t2 (n = 201)
Follow-up assessment t2 (n = 221)
Lost/reason: withdrew consent (n = 5), no reply (n = 21)
Lost/reason: withdrew consent (n = 7), no reply (n = 20)
Follow-up assessment t3 (n = 193)
Follow-up assessment t3 (n = 207)
Lost/reason: withdrew consent t2 (n = 5), no reply/empty questionnaire (n = 24), moved/dead (n = 5)
Follow-up assessment t4 (n = 185)
Lost/reason: withdrew consent t2 (n = 7), no reply/empty questionnaire (n = 24), moved/dead (n = 10)
Follow-up assessment t4 (n = 194)
Analysis
Lost/reason: withdrew consent t2 (n = 5), no reply/empty questionnaire (n = 27), moved/dead (n = 10)
Lost/reason: withdrew consent t2 (n = 7), no reply/empty questionnaire (n = 32), moved/dead (n = 15)
Analyzed (n = 216)
Analyzed (n = 233)
Data at t1 and at least at one of t2-t4
Data at t1 and at least at one of t2-t4
Excluded (n = 11)
Excluded (n = 15)
Only data at t1
Only data at t1 Fig. 1. Patient flow diagram.
Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010
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follow-up occasions, i.e., discharge (t2) and after 6 (t3) and 12 months (t4) using self-report questionnaires. Outcomes were HF self-management as well as HRQL and treatment satisfaction. Sample size was powered to detect small to medium effects in the primary outcome in short-, intermediate- and long-term (d = 0.3, 2-sided a = 0.05, 1-b = 0.8). Thus, 352 persons were required. Furthermore, a design effect of 1.18 was assumed, resulting in a necessary sample size of 416 patients. Power to detect smaller between-group effects on the secondary outcomes may be too low; thus, effect sizes were reported throughout. Details regarding methods according to CONSORT [11] have been previously described [12]. The trial conformed with the principles outlined by the Declaration of Helsinki and was approved by the Ethics Committee of the Faculty of Medicine, University of Würzburg on 19 April 2011 (reference number: 60/11).
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of the participants. Furthermore, the program focused on selfmanagement behaviours and medication adherence. To promote physical activity, theory-based intervention techniques [13] were applied. Additionally, illness related problems in everyday life and signs of emotional distress with regard to HF and coping strategies were discussed. Both program topics and didactics incorporated research evidence, guidelines, and quality criteria for patient-centred educational programs. Further details have been illustrated in the study protocol [12]. Control group (CG). Control condition was one lecture of basic illness related education given by a physician with a duration of about 60 min. Information was mostly presented in a vertical manner. Contents included basic medical HF disease information and self-management recommendations. Patients received three handouts, which comprised main information on HF, and worksheets.
2.2. Participants 2.4. Outcomes and measurements Patients were consecutively recruited between January 2012 and September 2013; one-year follow-up was finished in October 2014. Fig. 1 shows the study flow. A physician evaluated the inclusion criteria at admission for 580 patients based on initial interview, examination, patient record and latest diagnostic data. 571 patients eligible were asked to participate in the study, 513 signed the informed consent form (90%) and were allocated to a cluster and randomly assigned to a study group. 38 persons had to be excluded (e.g., withdrew consent, did not complete the questionnaire at baseline), finally 475 persons comprised the initial study sample. Follow-up rates exceeded 80% at all time points. Analyses were performed for all persons who participated in at least one follow-up assessment. Non-responder analyses revealed no differences between participants and non-participants for study group and gender, but older patients and rehabilitants admitted directly after an acute cardiac index event were less willing to participate (p < 0.001). Drop-out analyses for follow-up points were performed for study group, socio-demographic variables, type of rehabilitation, and main outcome variables. Results indicated no systematic sample bias because of patient drop-out over time. However, drop-outs at discharge were older, had a lower educational level and were less employed than completers. Drop-outs at the 6-months follow-up were less satisfied with their rehabilitation. The proportions of drop-outs were similar for both study groups and there were no systematic baseline differences between the follow-up samples (data not shown). 2.3. Intervention German inpatient multidisciplinary rehabilitation [7] includes medical treatment, exercise therapy/physical training, health education, psychological support, relaxation, and social counselling and comprises 21 days on average. In this trial, a selfmanagement group program was compared to a basic medical lecture (usual care). Intervention group (IG). Patients in the intervention condition received a self-management educational program that consisted of five patient-centred, interactive sessions of either 60 or 75 min each, which were provided in small groups of a closed format. The program was manual-based and interdisciplinary with sessions led by a physician, a nurse, a psychologist and a physiotherapist, respectively. In each session, patients were actively involved in the educational process using a combination of didactic methods. Didactic materials included presentations, flipcharts, and two patient booklets. Contents of the lessons included HF disease and treatment knowledge with regard to individual information needs
The primary outcome was patients’ subjective self-management competence (self-monitoring and insight, skill and technique acquisition, self-efficacy). Secondary outcomes included selfmanagement health behaviour (symptom control, physical activity, medication adherence), HRQL, and treatment satisfaction. Outcomes were generally assessed by validated measures. To assess symptom control a new measure was developed. 2.4.1. Self-monitoring and insight, skill and technique acquisition Two scales of the German version of the Health Education Impact Questionnaire (heiQ) were administered [14]. Six items capture individuals’ ability to monitor their condition, as well as their physical and/or emotional responses that leads to insight and appropriate actions to self-manage (e.g., “As well as seeing my doctor, I regularly monitor changes in my health”, “When I have health problems, I have a clear understanding of what I need to do to control them”). Four items measure the patients’ subjective knowledge-based skills and techniques to cope with diseaserelated symptoms and health problems (e.g., “When I have symptoms, I have skills that help me cope”, “I have a very good idea of how to manage my health problems”). Items were rated on a 4-point response scale (1 = “strongly disagree” to 4 = “strongly agree”) and averaged to the two heiQ-scales (range: 0 to 4), with higher values indicating better status, respectively. The scales had good reliability (Cronbach’s a 0.84 and 0.85). 2.4.2. Self-efficacy The Self-efficacy sub-scale of the Kansas City Cardiomyopathy Questionnaire (KCCQ) [15] comprises two items assessing whether a patient feels knowledgeable about how to manage his disease (manage symptoms, find answers and help). Higher scores indicate higher self-efficacy. 2.4.3. Symptom control A new measure was developed based on existing instruments [16] and program-content consisting of 10 items. Items were divided into 3 subscales—symptom monitoring (3 items; e.g., “I weight myself every day”), response to symptoms (3 items; e.g., “If my medical condition deteriorates I contact my doctor”), and prevention/diet (4 items; e.g., “I mind eating a low salt diet”). Items were answered on 4-point response scales (1 = “strongly disagree” to 4 = “strongly agree”) and were summed up into sum scores, with higher scores corresponding to stronger endorsement of the respective self-management strategy. Cronbach’s a for the subscales was between 0.73 and 0.74.
Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010
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2.4.4. Physical activity Participants reported how often per week and how long per session they performed strenuous, moderate, and light physical exercise (modified version of the Godin Leisure-Time Exercise Questionnaire [17]) outside of work duties. A total physical activity score (in minutes per week) was calculated by total number of sessions per week in each domain multiplied by minutes per session in each domain. 2.4.5. Medication adherence Patients completed the German version of the Medication Adherence Report Scale (MARS-D, [18]). The MARS-D is a 5-item measure with a 1 (“always”) to 5 (“never”) response format that assesses patients’ non-adherence behaviour (e.g., forgetting to take a dose or altering the dose). Items were summed up to form a sum score ranging from 5 to 25 points, with higher scores indicating greater medication adherence. The reliability score is 0.68. 2.4.6. HRQL (disease specific) Patients completed the German version of the KCCQ [15]. 23 items are used to quantify physical function, symptoms (frequency, severity and recent change), social function, selfefficacy, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency, severity), social function, and quality of life domains (Cronbach’s a 0.92). Scores are transformed to a range of 0–100, in which higher scores reflect better health status.
2.4.7. Treatment satisfaction Patients were asked to judge the educational program using 11 items [19]. Each item comprised patient-centred educational criteria on a 6-point scale (1 = “very good”, 6 = “very poor”). Items were averaged into 3 subscores—content (topic selection, comprehensibility, alignment, usefulness, delivery), group/interaction (opportunity to make comments, exchange of experience, group atmosphere, size), and materials (slides, handouts). Furthermore, one item inquired the satisfaction with the program in general. Scores showed good reliability (Cronbach’s a 0.77–0.85). 2.5. Statistical methods Statistical analyses were performed using SPSS 21.0 [20], R statistics [21], and Mplus 7.2 [22]. For missing data in accordance with missing at random, five imputed data sets were created using the multiple imputation procedure implemented in SPSS. Pooled estimates were computed using the BaBooN package and the Zelig package in R. Missing values due to drop-out were analysed by pair-wise deletion. Non-response and drop-out analyses were done by independent group comparisons using t tests for continuous variables and chi-square test for categorical variables. Due to hierarchical data, we explored the ICCs for primary and secondary outcomes. ICCs were generally low (< 0.05), so we decided to analyse data on level 1. Treatment effects (betweengroup effects) were evaluated separately for each follow-up time point using analysis of covariance (ANCOVA) adjusting for baseline values [23]. Statistical significance (p < 0.05, 2-sided) and effect sizes (d) were reported for all between-group differences. For two
Table 1 Baseline characteristics of the sample.
Male, n (%) Age in years, mean (SD) Marital status, n (%) Single Married/partner Divorced/separated Widowed Education, n (%)a Less than junior (<10 y; basic secondary school) Junior (10 y; middle-level secondary school) Senior (high-school graduate)b Other Working status, n (%)c Employed Retirement Unemployed Other LVEF, mean (SD)d NYHA II, n (%)a Cardiovascular implantable electronic devices, n (%)e Risk factorse Arterial hypertension, n (%) Cholesterol, n (%) Smokers, n (%) Diabetes mellitus, n (%) Positive family history, n (%) PHQ-4 depression, n (%) PHQ-4 anxiety, n (%) Cardiac rehabilitation within 14 days after an acute cardiac index event, n (%)
Control group (n = 227)
Intervention group (n = 248)
182 (80.2) 61.9 (11.2)
186 (75.0) 61.2 (11.7)
40 (17.6) 140 (61.7) 23 (10.1) 24 (10.6)
25 (10.1) 159 (64.1) 34 (13.7) 30 (12.1)
123 (54.7) 52 (23.1) 45 (20.0) 5 (2.2)
115 (47.9) 61 (25.4) 58 (24.2) 6 (2.5)
91 (40.4) 98 (43.6) 17 (7.6) 19 (8.4) 32.3 (6.7) 130 (59.1) 81 (35.7)
97 (39.3) 113 (45.7) 21 (8.5) 16 (6.5) 31.7 (7.0) 134 (54.7) 79 (32.1)
178 (78.9) 126 (55.5) 76 (33.3) 58 (25.6) 57 (25.1) 53 (23.3) 68 (27.4) 168 (75.3)
190 (77.2) 146 (59.3) 72 (29.3) 76 (30.9) 51 (20.7) 57 (25.1) 54 (21.8) 192 (78.4)
LVEF, left ventricular ejection fraction; NYHA, New York Heart Association class; PHQ-4, Patient Health Questionnaire-4. a Missing: n = 10. b Qualification for university or university of applied sciences entrance. c Missing: n = 3. d Missing: n = 4. e Missing: n = 2.
Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010
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primary outcomes (heiQ scales “self-monitoring and insight” and “skill and technique acquisition”), ANCOVAs with latent variables were computed additionally [24]. The third primary outcome (self efficacy) is measured by only two items. Therefore, latent variables could not be identified without additional constraints and we did not perform latent variable analysis with this outcome. For secondary outcomes, no adjustment for multiple tests was planned. In addition, within-group effects, including standardized effect sizes (SES) and accompanying 95% confidence intervals (CIs) were reported for both study groups. 3. Results 3.1. Patient characteristics The initial sample comprised 475 rehabilitants with HF (CG: n = 227; IG: n = 248). Table 1 presents the sociodemographic and clinical characteristics of participants by study group. 78% of the participants were male and the mean age was 62 years (SD = 11.1). About 57% had NYHA class II and 43% had NYHA class III symptoms. As shown, there were no systematic differences between participants in the CG and IG. 3.2. Primary outcome We found a significant, albeit small between-group intervention effect on certain dimension of patients’ self-management competence at discharge from inpatient rehabilitation. Participants of the IG, as compared to the CG, showed superior selfmonitoring and insight (latent analyses: p = 0.039, diff = 0.15;
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SESCG = 0.39, SESIG = 0.55) and by trend on skill and technique acquisition (latent analyses: p = 0.069, diff = 0.13; SESCG = 0.37, SESIG = 0.50) but not on self-efficacy (p = 0.424, d = 0.08; SESCG = 0.62, SESIG = 0.68). There were no significant between-group treatment effects 6 and 12 months after rehabilitation. Table 2 and Table 3 present the intermediate- and long-term results on primary and secondary outcomes. 3.3. Short-term effects on treatment satisfaction At discharge, rehabilitants of the IG indicated significant higher treatment satisfaction with the educational program they attended as compared to the CG. They showed higher satisfaction in general (p = 0.001; d = 0.31) as well as with regard of “content” (p = 0.039, d = 0.20), “group/interaction” (p < 0.001, d = 0.36). The small effect on “materials” failed significance (p = 0.051; d = 0.19). 3.4. Intermediate- and long-term effects on behavioural outcomes At 6-months follow-up, both IG and CG showed significant, small improvements in symptom control, that is symptom monitoring, response to symptoms and prevention/diet, and the amount of physical activity. SESs indicate that the IG improved more than the CG regarding physical activity. There was no significant increase for medication adherence in both groups, which may be due to high baseline-scores. ANCOVAs resulted in a significant, small effect in favour of the IG for symptom monitoring. No significant differences between the two groups were observed for further dimensions of symptom control, physical activity and medication adherence, though.
Table 2 Intermediate-term (6 months) within-group and between-group effects on primary and secondary outcomes. Pre-treatment
6-months follow-up
Within-group change
Between-group difference ANCOVA
mean (SD)
mean (SD)
SES (95% CI)
beta
p-value
d
0.02
0.685
0.04
0.04
0.392
0.09
0.71
0.666
0.04
0.49
0.031
0.22
Self-monitoring and insight Control group 3.22 (0.56) Intervention group 3.20 (0.54) Skill and technique acquisition Control group 2.97 (0.67) Intervention group 3.00 (0.62) Self-efficacy Control group 65.63 (23.64) Intervention group 64.03 (25.12) Symptom control symptom monitoring Control group 8.41 (2.49) Intervention group 8.69 (2.47) Symptom control response to symptoms Control group 9.95 (2.02) Intervention group 10.04 (1.65) Symptom control prevention/diet Control group 12.43 (2.52) Intervention group 12.07 (2.46) Physical activity (minutes per week) Control group 193.22 (195.51) Intervention group 155.07 (179.03) Medication adherence Control group 24.30 (1.38) Intervention group 23.99 (1.69) HRQL summary score Control group 58.79 (17.23) Intervention group 58.55 (21.52)
3.47 (0.47) 3.47 (0.47)
0.44 (0.29–0.58) 0.50 (0.36–0.65)
3.28 (0.58) 3.33 (0.55)
0.45 (0.30–0.60) 0.53 (0.38–0.68)
80.64 (17.03) 80.64 (16.94)
0.62 (0.43–0.80) 0.66 (0.49–0.83)
8.88 (2.51) 9.50 (2.47)
0.19 (0.06–0.32) 0.33 (0.16–0.49)
10.56 (1.62) 10.54 (1.60)
0.30 (0.15–0.45) 0.30 (0.15–0.46)
13.10 (2.39) 12.86 (2.32)
0.27 (0.12–0.41) 0.32 (0.18–0.47)
234.99 (218.41) 227.49 (201.12)
0.21 (0.05–0.37) 0.40 (0.24–0.57)
24.21 (1.52) 24.06 (1.18)
0.07 ( 0.22–0.08) 0.04 ( 0.12–0.20)
70.91 (18.95) 69.11 (22.03)
0.70 (0.54–0.87) 0.49 (0.36–0.62)
0.06
0.696
0.04
0.08
0.716
0.04
7.39
0.709
0.04
0.03
0.864
0.02
1.67
0.338
0.10
n = 400, control group: n = 193, intervention group: n = 207. ANCOVA indicates analysis of covariance; CI, confidence interval; SES, standardized effect size (positive SES represents improvement); beta, standardized regression coefficient; d, effect size. Effect size SES/d (small = 0.20, medium = 0.50, large = 0.80). Bold figures indicate: (a) regarding within-group effects: SES of the CG is outside the 95% CI of SES of the IG; or (b) regarding between-group effects: significant between-group effect (ANCOVA: p < 0.05).
Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010
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Table 3 Long-term (12 months) within-group and between-group effects on primary and secondary outcomes. Pre-treatment
12-months follow-up
Within-group change
Between-group difference ANCOVA
mean (SD)
mean (SD)
SES (95% CI)
beta
p-value
d
0.01
0.897
0.01
Self-monitoring and insight 3.27 (0.55) Control group Intervention group 3.20 (0.54) Skill and technique acquisition Control group 3.01 (0.66) Intervention group 2.99 (0.63) Self-efficacy Control group 67.46 (22.62) Intervention group 63.53 (25.41) Symptom control symptom monitoring Control group 8.44 (2.50) Intervention group 8.77 (2.35) Symptom control response to symptoms Control group 10.05 (1.96) Intervention group 10.04 (1.68) Symptom control prevention/diet 12.48 (2.50) Control group Intervention group 12.07 (2.42) Physical activity (minutes per week) Control group 193.17 (201.52) Intervention group 156.81 (181.33) Medication adherence Control group 24.29 (1.39) Intervention group 24.01 (1.66) HRQL summary score Control group 58.51 (17.36) Intervention group 59.06 (21.62)
3.49 (0.46) 3.47 (0.47)
0.41 (0.26–0.56) 0.49 (0.34–0.64)
3.35 (0.53) 3.33 (0.54)
0.51 (0.35–0.67) 0.54 (0.39–0.69)
82.64 (15.69) 81.19 (17.23)
0.67 (0.48–0.87) 0.69 (0.53–0.86)
8.69 (2.57) 9.21 (2.52)
0.10 ( 0.05–0.24) 0.18 (0.01–0.35)
10.45 (1.63) 10.48 (1.69)
0.21 (0.04–0.37) 0.26 (0.10–0.42)
12.96 (2.25) 12.99 (2.42)
0.19 (0.03–0.35) 0.38 (0.22–0.53)
225.57 (200.38) 239.06 (216.81)
0.16 (0.01–0.31) 0.45 (0.29–0.62)
24.15 (1.65) 24.18 (1.28)
0.10 ( 0.28–0.08) 0.10 ( 0.06–0.26)
72.80 (19.61) 71.33 (22.35)
0.82 (0.65–0.99) 0.57 (0.42–0.71)
0.01
0.766
0.03
0.58
0.721
0.04
0.38
0.113
0.16
0.03
0.863
0.02
0.19
0.394
0.09
29.70
0.132
0.16
0.10
0.477
0.07
1.78
0.330
0.10
n = 379, control group: n = 185, intervention group: n = 194. ANCOVA indicates analysis of covariance; CI, confidence interval; SES, standardized effect size (positive SES represents improvement); beta, standardized regression coefficient; d, effect size. Effect size SES/d (small = 0.20, medium = 0.50, large = 0.80). Bold figures indicate: (a) regarding within-group effects: SES of the CG is outside the 95% CI of SES of the IG; or (b) regarding between-group effects: significant between-group effect (ANCOVA: p < 0.05).
One year after rehabilitation, significant increases in symptom control and physical activity were maintained among patients of both groups. However, SESs indicated a rather small difference for symptom monitoring that failed significance in the CG. Again, medication adherence was unchanged at a high level. SESs indicated that the IG improved more than the CG with regard to prevention/diet, physical activity, and medication adherence. However, ANCOVAs showed no significant effects in favour of the IG for the behavioural outcomes. There were trends for intervention effects for symptom monitoring and physical activity, but the effects were small and failed significance (d = 0.16). After adjustment for baseline imbalance, estimated mean physical activity per week in the IG was about 30 min longer than in the CG. 3.5. Intermediate- and long-term effects on HRQL Both 6 and 12 months after rehabilitation significant improvements in terms of HRQL were evident in both groups, respectively. SESs indicated that the CG improved more than the IG. However, between-group analyses (ANCOVA) revealed no significant between-group intervention effects on HRQL. 4. Discussion and conclusion 4.1. Discussion In this cluster-RCT we evaluated the effectiveness of a patientcentred, self-management educational group program as compared to a short lecture program (usual care) within inpatient medical rehabilitation. Overall, we found a significant, but small intervention effect on certain dimension of our primary outcome patients’ self-management competence in short term.
Furthermore, significant, small effects were observed for treatment satisfaction at discharge as well as symptom monitoring after 6 months and by trend on symptom monitoring and physical activity after 12 months. However, there were no effects on further dimensions of symptom control, medication adherence, and HRQL. Thus, our primary and secondary hypotheses were only partially confirmed. Meanwhile, in a study testing an educational group program within inpatient rehabilitation followed by one aftercare telephone call, similar effects on proximal outcomes such as knowledge and self-monitoring, but no effects on self-efficacy or subjective health/HRQL have been shown [25]. Further studies in different settings provide evidence for effects of single HF education sessions with or without telephone follow-up on selfcare behaviours but not on HRQL [26]. The lack of additional effects may be explained by our active control condition and the high intensity of the whole rehabilitation package. The control condition in our study was also conducted in small groups and participants were able to ask questions within this session or during the further three-week treatment. Notably, the intervention comprised only a small amount of multidisciplinary rehabilitation treatments that all patients received. Thus, significant changes occurred in both groups and the incremental effect of the educational program may have been attenuated. Janssen et al. also reported in their systematic review that the effects of lifestyle modification programs on health behaviours of cardiac patients were smaller in trials using an active control condition [27]. Thus, the educational program was more likely to generate effects on special illness-related behaviours compared to general subjective competence (i.e., self-efficacy, and subjective behaviour-related knowledge or understanding) that strongly improved in both groups. Nevertheless, behavioral effects decreased over
Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010
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time and failed significance at 12-months follow-up. This might be due to motivational problems. Aftercare interventions as telephone follow up may be useful to sustaining results [25,26]. By contrast, neither study program resulted in differences across measurement occasions in medication adherence as measured by the MARS-D. However, as this measure produced ceiling effects [18] and may not have been sensitive to change. In addition, it remains unclear whether high scores were due to high adherence or over-reporting. Positive effects on treatment satisfaction have also been shown for other interactive patient education programs [28]. This might result from the high subjective information and communication needs of the population [29,30] as well as general demands of rehabilitants’ involvement [31]. The present study has certain limitations. First, all outcomes were measured by self-report, albeit with validated questionnaires. Objective measures would be preferable but could not be used in this context. However, direct measures each possess their own limitations [32]. Moreover, potential biases such as social desirability or inaccurate recall would apply in both study groups evaluated. Second, the outcome symptom control was assessed with a self-developed study-specific questionnaire. Factor structure and reliability was proven within the study, though. Third, the exclusion criteria cognitive impairment was not assessed by psychometric testing. Possible influences of cognitive performance were not examined. Fourth, the sample size calculation was powered to detect small-to-medium effects, as could be assumed for the primary outcome. Power to detect even smaller effects in the secondary outcomes may have been too low. Finally, the study did not focus on distal clinical outcomes, as this was not feasible in an inpatient setting. 4.2. Conclusion To our knowledge, this is the first RCT for a patient-centred selfmanagement group program for HF-patients in German rehabilitation centres. The study demonstrated that the program might be more effective regarding certain outcomes than a usual care education in both short-term and long-term periods. To further explore these results, subgroup-related treatment effects and analyses of treatment mechanisms will be conducted. 4.3. Practice implications For HF patients’ comprehensive patient education is warranted, but specific information on group program features and educational strategies is lacking. A patient-centred self-management group program might be more effective regarding certain selfmanagement outcomes than a lecture-based usual care education within inpatient cardiac rehabilitation. Therefore, such programs may be considered for dissemination within cardiac rehabilitation, but the expected additional benefits may be small. Conflict of interest The authors confirm that there is no conflict of interest. Acknowledgements This work was supported by the German Statutory Pension Insurance Scheme [grant number: 8011 - 106 - 31/31.93.1]. We thank the participating rehabilitation clinics (Rehabilitation Hospital Kirchberg-Klinik, Rehabilitation Hospital Möhnesee, Rehabilitation Hospital Wetterau, Segeberger Kliniken GmbH,
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Contents lists available at ScienceDirect
Patient Education and Counseling journal homepage: www.elsevier.com/locate/pateducou
The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation Karin Menga,* ,1, Gunda Musekampa,1, Michael Schulera , Bettina Seekatza , Johannes Glatzb , Gabriele Kargerc , Ulrich Kiwusd , Ernst Knoglingere , Rainer Schubmannf , Ronja Westphalg , Hermann Fallera a
Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Wuerzburg, Würzburg, Germany Rehabilitation Center Seehof, Teltow, Berlin, Germany c Rehabilitation Hospital Heidelberg-Königstuhl, Heidelberg, Germany d Rehabilitation Center Bad Nauheim—Rehabilitation Hospital Wetterau, Bad Nauheim, Germany e Rehabilitation Hospital Kirchberg-Klinik, Bad Lauterberg, Germany f Rehabilitation Hospital Möhnesee, Möhnesee, Germany g Segeberger Kliniken GmbH, Rehabilitation Hospital, Bad Segeberg, Germany b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 20 November 2015 Received in revised form 27 January 2016 Accepted 13 February 2016
Objective: To evaluate a patient-centred self-management educational group program for patients with chronic systolic heart failure as compared to usual care education during inpatient cardiac rehabilitation. Methods: A multicentre cluster randomized controlled trial of 475 patients was conducted. In the intervention condition, patients received the new self-management educational group program whereas in the control condition, patients received a short lecture-based educational program (usual care). The primary outcome was patients‘ self-reported self-management competence. Secondary outcomes included self-management health behaviour, health-related quality of life, and treatment satisfaction. Patients completed self-reported outcome measures at admission, discharge, and after 6 and 12 months. Results: There was a significant small between-group intervention effect on certain dimension of patients’ self-management competence (self-monitoring and insight) in short term (p < 0.05). Furthermore, significant small effects were observed for treatment satisfaction at discharge as well as symptom monitoring after 6 months (p < 0.05) and by trend on symptom monitoring and physical activity after 12 months. Conclusions: The patient-centred self-management program might be more effective in certain selfmanagement outcomes than a usual care education in both short-term and long-term periods. Practice implications: Therefore, such programs may be considered for dissemination within cardiac rehabilitation. ã 2016 Elsevier Ireland Ltd. All rights reserved.
Keywords: Chronic heart failure Patient education Self-management Evaluation Cluster-RCT Cardiac rehabilitation
1. Introduction Chronic heart failure (HF) is a disease that requires a complex treatment regimen over a life-long period. Therefore, self-care/ self-management is an essential part of successful treatment in patients with HF [1,2]. There is evidence for the effectiveness of
* Corresponding author at: University of Wuerzburg, Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences Klinikstr. 3, D-97070 Würzburg, Germany. Fax: +49 931 31827130. E-mail address: [email protected] (K. Meng). 1 Both authors contributed equally to this work.
self-management interventions and patient education for HF patients regarding knowledge, self-efficacy, self-management behaviours, health-related quality of life, hospitalization and mortality [e.g., [3–5]]. However, studies show methodological shortcomings and further research is needed to determine independent effects of specific self-management interventions as well as different combinations of interventions [4]. For HF patients, essential educational topics that should be covered include pathophysiology and aetiology, symptoms and signs, pharmacological treatment, risk factor modification, diet and exercise, sexual activity, immunization, sleep and breathing disorders, adherence, psychosocial aspects and prognosis, each
http://dx.doi.org/10.1016/j.pec.2016.02.010 0738-3991/ ã 2016 Elsevier Ireland Ltd. All rights reserved.
Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010
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associated with certain skills or self-management behaviours [2]. Thus, the focus on knowledge and providing information only may not be sufficient, and guidelines recommend comprehensive HF education and counselling targeting skills and behaviour [1,2]. Effective means for delivery may include individualization of content, use of combined mediums, provision of education on a one-on-one basis, and in multiple sessions, but studies that describe group delivery are missing [6]. Thus, studies need to explore the effects of patient education programs provided in a group format, as well as effects of specific educational techniques and identify subgroups of patients who benefit most. Patient education is an essential part of cardiac rehabilitation [7] for HF in Germany. Nevertheless, at the time of the conception of our study no evaluated educational group programs for HFpatients had been available for routine use so far. Moreover, many German patient education programs still lack certain quality requirements, such as the use of manuals, patient-oriented didactics, small-group format and evaluation of effectiveness [8]. In addition, few studies have compared different educational approaches applied within a multidisciplinary rehabilitation program in an inpatient setting [e.g., [9,10]]. Therefore, this study evaluated the short-, intermediate- and long-term effects of a patient-centred self-management educational group program as compared with a usual care program for HF patients receiving inpatient cardiac rehabilitation. We hypothesized that the self-management education group program is superior to usual care regarding self-reported self-management competence (primary outcome). In addition, we expected superior
effectiveness of the new program regarding several self-management behaviours, as well as health-related quality of life (HRQL), and treatment satisfaction (secondary outcomes). 2. Methods 2.1. Design and procedure This study was a multicentre cluster randomized controlled trial (RCT; WHO International Clinical Trials: DRKS00004841) in four cardiac rehabilitation clinics in Germany. Clusters were patient education groups that comprise HF patients recruited within two weeks after commencement of inpatient rehabilitation. Clusters were randomly assigned to the two treatment groups using a computer-generated list of random numbers. Randomization was performed by a scientific assistant at the research institute (central randomization per phone or e-mail) guarantying allocation concealment until a complete cluster had been recruited. Eligibility criteria for participants were a diagnosis of chronic systolic heart failure (ICD-10: I50), left ventricular ejection fraction (LVEF) of 40, and New York Heart Association (NYHA) functional classification II or III. Exclusion criteria were acute events of decompensation, cognitive impairment, inadequate German language ability, and severe visual or hearing impairment. In the intervention group (IG), patients received the new patientcentred self-management educational program, whereas in the control group (CG), patients received a short lecture program (usual care). Data were assessed at admission (t1) and three
Enrolment
Assessed for eligibility/ contacted for participation (n = 580) Excluded Not eligible (n = 9) Refused to participate (n = 58)
Follow-Up
Allocation
Agreed to participate/allocated to cluster (n = 513) Cluster randomization
Control group (n = 245 patients; n = 43 clusters)
Intervention group (n = 268 patients; n = 45 clusters)
Did not complete questionnaire (n = 14); Attended no intervention (n = 4)
Did not complete questionnaire (n = 7); Attended no intervention (n = 12); Met exclusion criterion (n = 1)
Received allocated intervention/ completed assessment t1 (n = 227)
Received allocated intervention/ completed assessment t1 (n = 248)
Follow-up assessment t2 (n = 201)
Follow-up assessment t2 (n = 221)
Lost/reason: withdrew consent (n = 5), no reply (n = 21)
Lost/reason: withdrew consent (n = 7), no reply (n = 20)
Follow-up assessment t3 (n = 193)
Follow-up assessment t3 (n = 207)
Lost/reason: withdrew consent t2 (n = 5), no reply/empty questionnaire (n = 24), moved/dead (n = 5)
Follow-up assessment t4 (n = 185)
Lost/reason: withdrew consent t2 (n = 7), no reply/empty questionnaire (n = 24), moved/dead (n = 10)
Follow-up assessment t4 (n = 194)
Analysis
Lost/reason: withdrew consent t2 (n = 5), no reply/empty questionnaire (n = 27), moved/dead (n = 10)
Lost/reason: withdrew consent t2 (n = 7), no reply/empty questionnaire (n = 32), moved/dead (n = 15)
Analyzed (n = 216)
Analyzed (n = 233)
Data at t1 and at least at one of t2-t4
Data at t1 and at least at one of t2-t4
Excluded (n = 11)
Excluded (n = 15)
Only data at t1
Only data at t1 Fig. 1. Patient flow diagram.
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follow-up occasions, i.e., discharge (t2) and after 6 (t3) and 12 months (t4) using self-report questionnaires. Outcomes were HF self-management as well as HRQL and treatment satisfaction. Sample size was powered to detect small to medium effects in the primary outcome in short-, intermediate- and long-term (d = 0.3, 2-sided a = 0.05, 1-b = 0.8). Thus, 352 persons were required. Furthermore, a design effect of 1.18 was assumed, resulting in a necessary sample size of 416 patients. Power to detect smaller between-group effects on the secondary outcomes may be too low; thus, effect sizes were reported throughout. Details regarding methods according to CONSORT [11] have been previously described [12]. The trial conformed with the principles outlined by the Declaration of Helsinki and was approved by the Ethics Committee of the Faculty of Medicine, University of Würzburg on 19 April 2011 (reference number: 60/11).
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of the participants. Furthermore, the program focused on selfmanagement behaviours and medication adherence. To promote physical activity, theory-based intervention techniques [13] were applied. Additionally, illness related problems in everyday life and signs of emotional distress with regard to HF and coping strategies were discussed. Both program topics and didactics incorporated research evidence, guidelines, and quality criteria for patient-centred educational programs. Further details have been illustrated in the study protocol [12]. Control group (CG). Control condition was one lecture of basic illness related education given by a physician with a duration of about 60 min. Information was mostly presented in a vertical manner. Contents included basic medical HF disease information and self-management recommendations. Patients received three handouts, which comprised main information on HF, and worksheets.
2.2. Participants 2.4. Outcomes and measurements Patients were consecutively recruited between January 2012 and September 2013; one-year follow-up was finished in October 2014. Fig. 1 shows the study flow. A physician evaluated the inclusion criteria at admission for 580 patients based on initial interview, examination, patient record and latest diagnostic data. 571 patients eligible were asked to participate in the study, 513 signed the informed consent form (90%) and were allocated to a cluster and randomly assigned to a study group. 38 persons had to be excluded (e.g., withdrew consent, did not complete the questionnaire at baseline), finally 475 persons comprised the initial study sample. Follow-up rates exceeded 80% at all time points. Analyses were performed for all persons who participated in at least one follow-up assessment. Non-responder analyses revealed no differences between participants and non-participants for study group and gender, but older patients and rehabilitants admitted directly after an acute cardiac index event were less willing to participate (p < 0.001). Drop-out analyses for follow-up points were performed for study group, socio-demographic variables, type of rehabilitation, and main outcome variables. Results indicated no systematic sample bias because of patient drop-out over time. However, drop-outs at discharge were older, had a lower educational level and were less employed than completers. Drop-outs at the 6-months follow-up were less satisfied with their rehabilitation. The proportions of drop-outs were similar for both study groups and there were no systematic baseline differences between the follow-up samples (data not shown). 2.3. Intervention German inpatient multidisciplinary rehabilitation [7] includes medical treatment, exercise therapy/physical training, health education, psychological support, relaxation, and social counselling and comprises 21 days on average. In this trial, a selfmanagement group program was compared to a basic medical lecture (usual care). Intervention group (IG). Patients in the intervention condition received a self-management educational program that consisted of five patient-centred, interactive sessions of either 60 or 75 min each, which were provided in small groups of a closed format. The program was manual-based and interdisciplinary with sessions led by a physician, a nurse, a psychologist and a physiotherapist, respectively. In each session, patients were actively involved in the educational process using a combination of didactic methods. Didactic materials included presentations, flipcharts, and two patient booklets. Contents of the lessons included HF disease and treatment knowledge with regard to individual information needs
The primary outcome was patients’ subjective self-management competence (self-monitoring and insight, skill and technique acquisition, self-efficacy). Secondary outcomes included selfmanagement health behaviour (symptom control, physical activity, medication adherence), HRQL, and treatment satisfaction. Outcomes were generally assessed by validated measures. To assess symptom control a new measure was developed. 2.4.1. Self-monitoring and insight, skill and technique acquisition Two scales of the German version of the Health Education Impact Questionnaire (heiQ) were administered [14]. Six items capture individuals’ ability to monitor their condition, as well as their physical and/or emotional responses that leads to insight and appropriate actions to self-manage (e.g., “As well as seeing my doctor, I regularly monitor changes in my health”, “When I have health problems, I have a clear understanding of what I need to do to control them”). Four items measure the patients’ subjective knowledge-based skills and techniques to cope with diseaserelated symptoms and health problems (e.g., “When I have symptoms, I have skills that help me cope”, “I have a very good idea of how to manage my health problems”). Items were rated on a 4-point response scale (1 = “strongly disagree” to 4 = “strongly agree”) and averaged to the two heiQ-scales (range: 0 to 4), with higher values indicating better status, respectively. The scales had good reliability (Cronbach’s a 0.84 and 0.85). 2.4.2. Self-efficacy The Self-efficacy sub-scale of the Kansas City Cardiomyopathy Questionnaire (KCCQ) [15] comprises two items assessing whether a patient feels knowledgeable about how to manage his disease (manage symptoms, find answers and help). Higher scores indicate higher self-efficacy. 2.4.3. Symptom control A new measure was developed based on existing instruments [16] and program-content consisting of 10 items. Items were divided into 3 subscales—symptom monitoring (3 items; e.g., “I weight myself every day”), response to symptoms (3 items; e.g., “If my medical condition deteriorates I contact my doctor”), and prevention/diet (4 items; e.g., “I mind eating a low salt diet”). Items were answered on 4-point response scales (1 = “strongly disagree” to 4 = “strongly agree”) and were summed up into sum scores, with higher scores corresponding to stronger endorsement of the respective self-management strategy. Cronbach’s a for the subscales was between 0.73 and 0.74.
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2.4.4. Physical activity Participants reported how often per week and how long per session they performed strenuous, moderate, and light physical exercise (modified version of the Godin Leisure-Time Exercise Questionnaire [17]) outside of work duties. A total physical activity score (in minutes per week) was calculated by total number of sessions per week in each domain multiplied by minutes per session in each domain. 2.4.5. Medication adherence Patients completed the German version of the Medication Adherence Report Scale (MARS-D, [18]). The MARS-D is a 5-item measure with a 1 (“always”) to 5 (“never”) response format that assesses patients’ non-adherence behaviour (e.g., forgetting to take a dose or altering the dose). Items were summed up to form a sum score ranging from 5 to 25 points, with higher scores indicating greater medication adherence. The reliability score is 0.68. 2.4.6. HRQL (disease specific) Patients completed the German version of the KCCQ [15]. 23 items are used to quantify physical function, symptoms (frequency, severity and recent change), social function, selfefficacy, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency, severity), social function, and quality of life domains (Cronbach’s a 0.92). Scores are transformed to a range of 0–100, in which higher scores reflect better health status.
2.4.7. Treatment satisfaction Patients were asked to judge the educational program using 11 items [19]. Each item comprised patient-centred educational criteria on a 6-point scale (1 = “very good”, 6 = “very poor”). Items were averaged into 3 subscores—content (topic selection, comprehensibility, alignment, usefulness, delivery), group/interaction (opportunity to make comments, exchange of experience, group atmosphere, size), and materials (slides, handouts). Furthermore, one item inquired the satisfaction with the program in general. Scores showed good reliability (Cronbach’s a 0.77–0.85). 2.5. Statistical methods Statistical analyses were performed using SPSS 21.0 [20], R statistics [21], and Mplus 7.2 [22]. For missing data in accordance with missing at random, five imputed data sets were created using the multiple imputation procedure implemented in SPSS. Pooled estimates were computed using the BaBooN package and the Zelig package in R. Missing values due to drop-out were analysed by pair-wise deletion. Non-response and drop-out analyses were done by independent group comparisons using t tests for continuous variables and chi-square test for categorical variables. Due to hierarchical data, we explored the ICCs for primary and secondary outcomes. ICCs were generally low (< 0.05), so we decided to analyse data on level 1. Treatment effects (betweengroup effects) were evaluated separately for each follow-up time point using analysis of covariance (ANCOVA) adjusting for baseline values [23]. Statistical significance (p < 0.05, 2-sided) and effect sizes (d) were reported for all between-group differences. For two
Table 1 Baseline characteristics of the sample.
Male, n (%) Age in years, mean (SD) Marital status, n (%) Single Married/partner Divorced/separated Widowed Education, n (%)a Less than junior (<10 y; basic secondary school) Junior (10 y; middle-level secondary school) Senior (high-school graduate)b Other Working status, n (%)c Employed Retirement Unemployed Other LVEF, mean (SD)d NYHA II, n (%)a Cardiovascular implantable electronic devices, n (%)e Risk factorse Arterial hypertension, n (%) Cholesterol, n (%) Smokers, n (%) Diabetes mellitus, n (%) Positive family history, n (%) PHQ-4 depression, n (%) PHQ-4 anxiety, n (%) Cardiac rehabilitation within 14 days after an acute cardiac index event, n (%)
Control group (n = 227)
Intervention group (n = 248)
182 (80.2) 61.9 (11.2)
186 (75.0) 61.2 (11.7)
40 (17.6) 140 (61.7) 23 (10.1) 24 (10.6)
25 (10.1) 159 (64.1) 34 (13.7) 30 (12.1)
123 (54.7) 52 (23.1) 45 (20.0) 5 (2.2)
115 (47.9) 61 (25.4) 58 (24.2) 6 (2.5)
91 (40.4) 98 (43.6) 17 (7.6) 19 (8.4) 32.3 (6.7) 130 (59.1) 81 (35.7)
97 (39.3) 113 (45.7) 21 (8.5) 16 (6.5) 31.7 (7.0) 134 (54.7) 79 (32.1)
178 (78.9) 126 (55.5) 76 (33.3) 58 (25.6) 57 (25.1) 53 (23.3) 68 (27.4) 168 (75.3)
190 (77.2) 146 (59.3) 72 (29.3) 76 (30.9) 51 (20.7) 57 (25.1) 54 (21.8) 192 (78.4)
LVEF, left ventricular ejection fraction; NYHA, New York Heart Association class; PHQ-4, Patient Health Questionnaire-4. a Missing: n = 10. b Qualification for university or university of applied sciences entrance. c Missing: n = 3. d Missing: n = 4. e Missing: n = 2.
Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010
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primary outcomes (heiQ scales “self-monitoring and insight” and “skill and technique acquisition”), ANCOVAs with latent variables were computed additionally [24]. The third primary outcome (self efficacy) is measured by only two items. Therefore, latent variables could not be identified without additional constraints and we did not perform latent variable analysis with this outcome. For secondary outcomes, no adjustment for multiple tests was planned. In addition, within-group effects, including standardized effect sizes (SES) and accompanying 95% confidence intervals (CIs) were reported for both study groups. 3. Results 3.1. Patient characteristics The initial sample comprised 475 rehabilitants with HF (CG: n = 227; IG: n = 248). Table 1 presents the sociodemographic and clinical characteristics of participants by study group. 78% of the participants were male and the mean age was 62 years (SD = 11.1). About 57% had NYHA class II and 43% had NYHA class III symptoms. As shown, there were no systematic differences between participants in the CG and IG. 3.2. Primary outcome We found a significant, albeit small between-group intervention effect on certain dimension of patients’ self-management competence at discharge from inpatient rehabilitation. Participants of the IG, as compared to the CG, showed superior selfmonitoring and insight (latent analyses: p = 0.039, diff = 0.15;
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SESCG = 0.39, SESIG = 0.55) and by trend on skill and technique acquisition (latent analyses: p = 0.069, diff = 0.13; SESCG = 0.37, SESIG = 0.50) but not on self-efficacy (p = 0.424, d = 0.08; SESCG = 0.62, SESIG = 0.68). There were no significant between-group treatment effects 6 and 12 months after rehabilitation. Table 2 and Table 3 present the intermediate- and long-term results on primary and secondary outcomes. 3.3. Short-term effects on treatment satisfaction At discharge, rehabilitants of the IG indicated significant higher treatment satisfaction with the educational program they attended as compared to the CG. They showed higher satisfaction in general (p = 0.001; d = 0.31) as well as with regard of “content” (p = 0.039, d = 0.20), “group/interaction” (p < 0.001, d = 0.36). The small effect on “materials” failed significance (p = 0.051; d = 0.19). 3.4. Intermediate- and long-term effects on behavioural outcomes At 6-months follow-up, both IG and CG showed significant, small improvements in symptom control, that is symptom monitoring, response to symptoms and prevention/diet, and the amount of physical activity. SESs indicate that the IG improved more than the CG regarding physical activity. There was no significant increase for medication adherence in both groups, which may be due to high baseline-scores. ANCOVAs resulted in a significant, small effect in favour of the IG for symptom monitoring. No significant differences between the two groups were observed for further dimensions of symptom control, physical activity and medication adherence, though.
Table 2 Intermediate-term (6 months) within-group and between-group effects on primary and secondary outcomes. Pre-treatment
6-months follow-up
Within-group change
Between-group difference ANCOVA
mean (SD)
mean (SD)
SES (95% CI)
beta
p-value
d
0.02
0.685
0.04
0.04
0.392
0.09
0.71
0.666
0.04
0.49
0.031
0.22
Self-monitoring and insight Control group 3.22 (0.56) Intervention group 3.20 (0.54) Skill and technique acquisition Control group 2.97 (0.67) Intervention group 3.00 (0.62) Self-efficacy Control group 65.63 (23.64) Intervention group 64.03 (25.12) Symptom control symptom monitoring Control group 8.41 (2.49) Intervention group 8.69 (2.47) Symptom control response to symptoms Control group 9.95 (2.02) Intervention group 10.04 (1.65) Symptom control prevention/diet Control group 12.43 (2.52) Intervention group 12.07 (2.46) Physical activity (minutes per week) Control group 193.22 (195.51) Intervention group 155.07 (179.03) Medication adherence Control group 24.30 (1.38) Intervention group 23.99 (1.69) HRQL summary score Control group 58.79 (17.23) Intervention group 58.55 (21.52)
3.47 (0.47) 3.47 (0.47)
0.44 (0.29–0.58) 0.50 (0.36–0.65)
3.28 (0.58) 3.33 (0.55)
0.45 (0.30–0.60) 0.53 (0.38–0.68)
80.64 (17.03) 80.64 (16.94)
0.62 (0.43–0.80) 0.66 (0.49–0.83)
8.88 (2.51) 9.50 (2.47)
0.19 (0.06–0.32) 0.33 (0.16–0.49)
10.56 (1.62) 10.54 (1.60)
0.30 (0.15–0.45) 0.30 (0.15–0.46)
13.10 (2.39) 12.86 (2.32)
0.27 (0.12–0.41) 0.32 (0.18–0.47)
234.99 (218.41) 227.49 (201.12)
0.21 (0.05–0.37) 0.40 (0.24–0.57)
24.21 (1.52) 24.06 (1.18)
0.07 ( 0.22–0.08) 0.04 ( 0.12–0.20)
70.91 (18.95) 69.11 (22.03)
0.70 (0.54–0.87) 0.49 (0.36–0.62)
0.06
0.696
0.04
0.08
0.716
0.04
7.39
0.709
0.04
0.03
0.864
0.02
1.67
0.338
0.10
n = 400, control group: n = 193, intervention group: n = 207. ANCOVA indicates analysis of covariance; CI, confidence interval; SES, standardized effect size (positive SES represents improvement); beta, standardized regression coefficient; d, effect size. Effect size SES/d (small = 0.20, medium = 0.50, large = 0.80). Bold figures indicate: (a) regarding within-group effects: SES of the CG is outside the 95% CI of SES of the IG; or (b) regarding between-group effects: significant between-group effect (ANCOVA: p < 0.05).
Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010
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Table 3 Long-term (12 months) within-group and between-group effects on primary and secondary outcomes. Pre-treatment
12-months follow-up
Within-group change
Between-group difference ANCOVA
mean (SD)
mean (SD)
SES (95% CI)
beta
p-value
d
0.01
0.897
0.01
Self-monitoring and insight 3.27 (0.55) Control group Intervention group 3.20 (0.54) Skill and technique acquisition Control group 3.01 (0.66) Intervention group 2.99 (0.63) Self-efficacy Control group 67.46 (22.62) Intervention group 63.53 (25.41) Symptom control symptom monitoring Control group 8.44 (2.50) Intervention group 8.77 (2.35) Symptom control response to symptoms Control group 10.05 (1.96) Intervention group 10.04 (1.68) Symptom control prevention/diet 12.48 (2.50) Control group Intervention group 12.07 (2.42) Physical activity (minutes per week) Control group 193.17 (201.52) Intervention group 156.81 (181.33) Medication adherence Control group 24.29 (1.39) Intervention group 24.01 (1.66) HRQL summary score Control group 58.51 (17.36) Intervention group 59.06 (21.62)
3.49 (0.46) 3.47 (0.47)
0.41 (0.26–0.56) 0.49 (0.34–0.64)
3.35 (0.53) 3.33 (0.54)
0.51 (0.35–0.67) 0.54 (0.39–0.69)
82.64 (15.69) 81.19 (17.23)
0.67 (0.48–0.87) 0.69 (0.53–0.86)
8.69 (2.57) 9.21 (2.52)
0.10 ( 0.05–0.24) 0.18 (0.01–0.35)
10.45 (1.63) 10.48 (1.69)
0.21 (0.04–0.37) 0.26 (0.10–0.42)
12.96 (2.25) 12.99 (2.42)
0.19 (0.03–0.35) 0.38 (0.22–0.53)
225.57 (200.38) 239.06 (216.81)
0.16 (0.01–0.31) 0.45 (0.29–0.62)
24.15 (1.65) 24.18 (1.28)
0.10 ( 0.28–0.08) 0.10 ( 0.06–0.26)
72.80 (19.61) 71.33 (22.35)
0.82 (0.65–0.99) 0.57 (0.42–0.71)
0.01
0.766
0.03
0.58
0.721
0.04
0.38
0.113
0.16
0.03
0.863
0.02
0.19
0.394
0.09
29.70
0.132
0.16
0.10
0.477
0.07
1.78
0.330
0.10
n = 379, control group: n = 185, intervention group: n = 194. ANCOVA indicates analysis of covariance; CI, confidence interval; SES, standardized effect size (positive SES represents improvement); beta, standardized regression coefficient; d, effect size. Effect size SES/d (small = 0.20, medium = 0.50, large = 0.80). Bold figures indicate: (a) regarding within-group effects: SES of the CG is outside the 95% CI of SES of the IG; or (b) regarding between-group effects: significant between-group effect (ANCOVA: p < 0.05).
One year after rehabilitation, significant increases in symptom control and physical activity were maintained among patients of both groups. However, SESs indicated a rather small difference for symptom monitoring that failed significance in the CG. Again, medication adherence was unchanged at a high level. SESs indicated that the IG improved more than the CG with regard to prevention/diet, physical activity, and medication adherence. However, ANCOVAs showed no significant effects in favour of the IG for the behavioural outcomes. There were trends for intervention effects for symptom monitoring and physical activity, but the effects were small and failed significance (d = 0.16). After adjustment for baseline imbalance, estimated mean physical activity per week in the IG was about 30 min longer than in the CG. 3.5. Intermediate- and long-term effects on HRQL Both 6 and 12 months after rehabilitation significant improvements in terms of HRQL were evident in both groups, respectively. SESs indicated that the CG improved more than the IG. However, between-group analyses (ANCOVA) revealed no significant between-group intervention effects on HRQL. 4. Discussion and conclusion 4.1. Discussion In this cluster-RCT we evaluated the effectiveness of a patientcentred, self-management educational group program as compared to a short lecture program (usual care) within inpatient medical rehabilitation. Overall, we found a significant, but small intervention effect on certain dimension of our primary outcome patients’ self-management competence in short term.
Furthermore, significant, small effects were observed for treatment satisfaction at discharge as well as symptom monitoring after 6 months and by trend on symptom monitoring and physical activity after 12 months. However, there were no effects on further dimensions of symptom control, medication adherence, and HRQL. Thus, our primary and secondary hypotheses were only partially confirmed. Meanwhile, in a study testing an educational group program within inpatient rehabilitation followed by one aftercare telephone call, similar effects on proximal outcomes such as knowledge and self-monitoring, but no effects on self-efficacy or subjective health/HRQL have been shown [25]. Further studies in different settings provide evidence for effects of single HF education sessions with or without telephone follow-up on selfcare behaviours but not on HRQL [26]. The lack of additional effects may be explained by our active control condition and the high intensity of the whole rehabilitation package. The control condition in our study was also conducted in small groups and participants were able to ask questions within this session or during the further three-week treatment. Notably, the intervention comprised only a small amount of multidisciplinary rehabilitation treatments that all patients received. Thus, significant changes occurred in both groups and the incremental effect of the educational program may have been attenuated. Janssen et al. also reported in their systematic review that the effects of lifestyle modification programs on health behaviours of cardiac patients were smaller in trials using an active control condition [27]. Thus, the educational program was more likely to generate effects on special illness-related behaviours compared to general subjective competence (i.e., self-efficacy, and subjective behaviour-related knowledge or understanding) that strongly improved in both groups. Nevertheless, behavioral effects decreased over
Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010
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time and failed significance at 12-months follow-up. This might be due to motivational problems. Aftercare interventions as telephone follow up may be useful to sustaining results [25,26]. By contrast, neither study program resulted in differences across measurement occasions in medication adherence as measured by the MARS-D. However, as this measure produced ceiling effects [18] and may not have been sensitive to change. In addition, it remains unclear whether high scores were due to high adherence or over-reporting. Positive effects on treatment satisfaction have also been shown for other interactive patient education programs [28]. This might result from the high subjective information and communication needs of the population [29,30] as well as general demands of rehabilitants’ involvement [31]. The present study has certain limitations. First, all outcomes were measured by self-report, albeit with validated questionnaires. Objective measures would be preferable but could not be used in this context. However, direct measures each possess their own limitations [32]. Moreover, potential biases such as social desirability or inaccurate recall would apply in both study groups evaluated. Second, the outcome symptom control was assessed with a self-developed study-specific questionnaire. Factor structure and reliability was proven within the study, though. Third, the exclusion criteria cognitive impairment was not assessed by psychometric testing. Possible influences of cognitive performance were not examined. Fourth, the sample size calculation was powered to detect small-to-medium effects, as could be assumed for the primary outcome. Power to detect even smaller effects in the secondary outcomes may have been too low. Finally, the study did not focus on distal clinical outcomes, as this was not feasible in an inpatient setting. 4.2. Conclusion To our knowledge, this is the first RCT for a patient-centred selfmanagement group program for HF-patients in German rehabilitation centres. The study demonstrated that the program might be more effective regarding certain outcomes than a usual care education in both short-term and long-term periods. To further explore these results, subgroup-related treatment effects and analyses of treatment mechanisms will be conducted. 4.3. Practice implications For HF patients’ comprehensive patient education is warranted, but specific information on group program features and educational strategies is lacking. A patient-centred self-management group program might be more effective regarding certain selfmanagement outcomes than a lecture-based usual care education within inpatient cardiac rehabilitation. Therefore, such programs may be considered for dissemination within cardiac rehabilitation, but the expected additional benefits may be small. Conflict of interest The authors confirm that there is no conflict of interest. Acknowledgements This work was supported by the German Statutory Pension Insurance Scheme [grant number: 8011 - 106 - 31/31.93.1]. We thank the participating rehabilitation clinics (Rehabilitation Hospital Kirchberg-Klinik, Rehabilitation Hospital Möhnesee, Rehabilitation Hospital Wetterau, Segeberger Kliniken GmbH,
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Please cite this article in press as: K. Meng, et al., The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation, Patient Educ Couns (2016), http://dx.doi.org/10.1016/j.pec.2016.02.010