Evaluation of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation: study protocol of a cluster randomized controlled trial

BMC Cardiovascular Disorders

Hermann Faller³  Ronja Westphal¹  Rainer Schubmann⁶  Ernst Knoglinger⁵  Ulrich Kiwus⁷  Gabriele Karger²  Johannes Glatz⁴  Bettina Seekatz³  Gunda Musekamp³  Karin Meng³ 

[1] Segeberger Kliniken GmbH, Rehabilitation Hospital, Am Kurpark 1, Bad Segeberg 23795, Germany;Rehabilitation Hospital Heidelberg-Königstuhl, Kohlhof 8, Heidelberg 69117, Germany;Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Wuerzburg, Klinikstr. 3, Würzburg 97070, Germany;Rehabilitation Center Seehof, Lichterfelder Allee 55, Teltow/Berlin 14513, Germany;Rehabilitation Hospital Kirchberg-Klinik, Kirchberg 7-11, Bad Lauterberg 37431, Germany;Rehabilitation Hospital Möhnesee, Schnappweg 2, Möhnesee 59519, Germany;Rehabilitation Center Bad Nauheim - Rehabilitation Hospital Wetterau and Taunus, Zanderstr. 30-32, Bad Nauheim 61231, Germany

关键词: Cardiac rehabilitation;    Cluster-RCT;    Evaluation;    Self-management;    Patient education;    Chronic heart failure;   

Others  :  857544
DOI  :  10.1186/1471-2261-13-60

 received in 2013-05-10, accepted in 2013-08-19,  发布年份 2013

【 摘 要 】

Background

Chronic heart failure requires a complex treatment regimen on a life-long basis. Therefore, self-care/self-management is an essential part of successful treatment and comprehensive patient education is warranted. However, specific information on program features and educational strategies enhancing treatment success is lacking. This trial aims to evaluate a patient-oriented and theory-based self-management educational group program as compared to usual care education during inpatient cardiac rehabilitation in Germany.

Methods/Design

The study is a multicenter cluster randomized controlled trial in four cardiac rehabilitation clinics. Clusters are patient education groups that comprise HF patients recruited within 2 weeks after commencement of inpatient cardiac rehabilitation. Cluster randomization was chosen for pragmatic reasons, i.e. to ensure a sufficient number of eligible patients to build large-enough educational groups and to prevent contamination by interaction of patients from different treatment allocations during rehabilitation. Rehabilitants with chronic systolic heart failure (n = 540) will be consecutively recruited for the study at the beginning of inpatient rehabilitation. Data will be assessed at admission, at discharge and after 6 and 12 months using patient questionnaires. In the intervention condition, patients receive the new patient-oriented self-management educational program, whereas in the control condition, patients receive a short lecture-based educational program (usual care). The primary outcome is patients’ self-reported self-management competence. Secondary outcomes include behavioral determinants and self-management health behavior (symptom monitoring, physical activity, medication adherence), health-related quality of life, and treatment satisfaction. Treatment effects will be evaluated separately for each follow-up time point using multilevel regression analysis, and adjusting for baseline values.

Discussion

This study evaluates the effectiveness of a comprehensive self-management educational program by a cluster randomized trial within inpatient cardiac rehabilitation in Germany. Furthermore, subgroup-related treatment effects will be explored. Study results will contribute to a better understanding of both the effectiveness and mechanisms of a self-management group program as part of cardiac rehabilitation.

Trial registration

German Clinical Trials Register: DRKS00004841; WHO International Clinical Trials: = DRKS00004841

【 授权许可】

   
2013 Meng et al.; licensee BioMed Central Ltd.

【 图 表 】

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