title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  German Clinical Trials Register: DRKS00004841; WHO International Clinical Trials: = DRKS00004841.
authors: Karin
authors: K
authors: Meng
authors: Gunda
authors: G
authors: Musekamp
authors: Bettina
authors: B
authors: Seekatz
authors: Johannes
authors: J
authors: Glatz
authors: Gabriele
authors: G
authors: Karger
authors: Ulrich
authors: U
authors: Kiwus
authors: Ernst
authors: E
authors: Knoglinger
authors: Rainer
authors: R
authors: Schubmann
authors: Ronja
authors: R
authors: Westphal
authors: Hermann
authors: H
authors: Faller
mesh_terms: D006801:Humans; D002908:Chronic Disease; D015438:Health Behavior; D006333:Heart Failure / Q000628:therapy; D006760:Hospitalization; D055118:Medication Adherence; D009043:Motor Activity; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D011788:Quality of Life; D012648:Self Care / Q000379:methods
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