Effectiveness of a self-management patient education program "Curriculum Heart Failure" for inpatient cardiac rehabilitation.
The aim of the study is to evaluate a self-management patient education program for heart failure in medical rehabilitation. The main question is the short-, intermediate and long-term effects of the patient-oriented educational program as compared with a usual care program for HF-patients receiving inpatient medical rehabilitation. Moreover, moderator effects of gender, age, education, and type of rehabilitation (cardiac rehabilitation within 14 days after an acute cardiac index event versus cardiac rehabilitation during the chronic course of disease without recent acute index event) will be explored. The study is a multicenter cluster randomized controlled trial in four cardiac rehabilitation clinics. Clusters are patient education groups that comprise HF-patients which start inpatient medical rehabilitation within certain time periods of about 2 weeks. A cluster randomization was chosen for practical reasons, i.e. the number of eligible patients to join the educational groups. Furthermore, to prevent contamination by interaction of patients with different group allocation 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 with patient-reported questionnaires. In the intervention group (IG), patients receive the new patient-oriented self-management education program, whereas in the control group (CG), patients receive a basic educational program (usual care). The primary outcome is patients` subjective 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. Outcomes are assessed by standardized measures. Treatment effects (between-group effects of IG and CG) will be evaluated separately for each follow-up time point using multilevel regression analysis, and adjusting for baseline values. Moderator analysis will be performed by including the moderator variable as additional fixed effect and examining interaction effects.