Design and methodology of the COACH study: a multicenter randomised Coordinating study evaluating Outcomes of Advising and Counselling in Heart failure

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Abstract
While there are data to support the use of comprehensive non-pharmacological intervention programs in patients with heart failure (HF), other studies have not confirmed these positive findings. Substantial differences in the type and intensity of disease management programs make it impossible to draw definitive conclusions about the effectiveness, optimal timing and frequency of interventions. 1. To determine the effectiveness of two interventions (basic support vs. intensive support) compared to 'care as usual' in HF patients, on time to first major event (HF readmission or death), quality of life and costs. 2. To investigate the role of underlying mechanisms (knowledge, beliefs, self-care behaviour, compliance) on the effectiveness of the two interventions. This is a randomised controlled trial in which 1050 patients with heart failure will be randomised into three treatment arms: care as usual, basic education and support or intensive education and support. Outcomes of this study are; time to first major event (HF hospitalisation or death), quality of life (Minnesota Living with HF Questionnaire, RAND36 and Ladder of Life) and costs. Data will be collected during initial admission and then 1, 6, 12, and 18 months after discharge. In addition, data on knowledge, beliefs, self-care behaviour and compliance will be collected. The study started in January 2002 and results are expected at the end of 2005. This study will help health care providers in future to make rational and informed choices about which components of a HF management program should be expanded and which components can possibly be deleted.