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/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.
journal_name
BMC Cardiovasc Disordjournal_title
BMC cardiovascular disordersauthors
Meng K,Musekamp G,Seekatz B,Glatz J,Karger G,Kiwus U,Knoglinger E,Schubmann R,Westphal R,Faller Hdoi
10.1186/1471-2261-13-60subject
Has Abstractpub_date
2013-08-23 00:00:00pages
60issn
1471-2261pii
1471-2261-13-60journal_volume
13pub_type
杂志文章,多中心研究abstract:BACKGROUND:To explore why bicuspid aortic stenosis has certain clinical differences from the tricuspid morphology, we evaluated the metabolomics profile involved in bicuspid aortic valve (BAV) aortic stenosis prior to and after transcatheter aortic valve replacement (TAVR) in comparison with tricuspid aortic valve (TAV...
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pub_type: 杂志文章,多中心研究
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pub_type: 临床试验,杂志文章,多中心研究
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pub_type: 杂志文章
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pub_type: 杂志文章,随机对照试验
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pub_type: 杂志文章
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更新日期:2013-07-28 00:00:00
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pub_type: 杂志文章,meta分析
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pub_type: 杂志文章,meta分析,评审
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pub_type: 杂志文章,meta分析
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pub_type: 杂志文章
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更新日期:2002-09-21 00:00:00