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Evaluation of a self-management programme for congestive heart failure patients: design of a randomised controlled
Esther S T F Smeulders1, Jolanda C M van Haastregt, Elisabeth F M van Hoef
1Maastricht University, Faculty of Health Sciences, Department of Health Care Studies, P.O. Box 616, 6200 MD Maastricht, The Netherlands. e.smeulders@zw.unimaas.nl
Insights
This study evaluates the Chronic Disease Self-Management Program (CDSMP) for congestive heart failure (CHF) patients. The randomized controlled trial assesses its impact on quality of life and healthcare use.
Area of Science:
- Cardiology
- Health Psychology
- Clinical Trials
Background:
- Congestive heart failure (CHF) significantly impacts patient quality of life and healthcare utilization.
- Effective self-management is crucial for patients with chronic conditions like CHF.
- The Chronic Disease Self-Management Program (CDSMP) has shown promise for various chronic conditions but not specifically for CHF.
Purpose of the Study:
- To design and conduct a randomized controlled trial (RCT) evaluating the CDSMP for CHF patients.
- To assess the effects of CDSMP on psychosocial factors, health behaviors, quality of life, and healthcare utilization in CHF patients.
Main Methods:
- A two-group randomized controlled trial (RCT) involving 318 CHF patients with physical activity limitations.
- Intervention group received the six-week CDSMP; control group received usual care.
- Follow-up assessments at immediate post-intervention, 6, and 12 months, measuring primary outcomes (self-efficacy, perceived control, symptom management) and secondary outcomes (health behaviors, quality of life, healthcare utilization).
Main Results:
- Data collection is ongoing, with results expected after January 2007.
- The trial aims to provide insights into the effectiveness of CDSMP for CHF management.
- Feasibility will be assessed through protocol compliance, attendance, and patient feedback.
Conclusions:
- The study is designed to determine the efficacy of the CDSMP in improving outcomes for congestive heart failure patients.
- Results will inform the potential integration of CDSMP into standard care for CHF management.
- This trial addresses a gap in evidence regarding self-management programs for this specific patient population.
Background:
Congestive heart failure (CHF) has a substantial impact on care utilisation and quality of life. It is crucial for patients to cope with CHF adequately, if they are to live an acceptable life. Self-management may play an important role in this regard. Previous studies have shown the effectiveness of the 'Chronic Disease Self-Management Program' (CDSMP), a group-based cognitive behavioural programme for patients with various chronic conditions. However, the programme's effectiveness has not yet been studied specifically among CHF patients. This paper presents the design of a randomised controlled trial to evaluate the effects of the CDSMP on psychosocial attributes, health behaviour, quality of life, and health care utilisation of CHF patients.
Methods/Design:
The programme is being evaluated in a two-group randomised controlled trial. Patients were eligible if they had been diagnosed with CHF and experienced slight to marked limitation of physical activity. They were selected from the Heart Failure and/or Cardiology Outpatient Clinics of six hospitals. Eligible patients underwent a baseline assessment and were subsequently allocated to the intervention or control group. Patients allocated to the intervention group were invited to attend the self-management programme consisting of six weekly sessions, led by a CHF nurse specialist and a CHF patient. Those allocated to the control group received care as usual. Follow-up measurements are being carried out immediately after the intervention period, and six and twelve months after the start of the intervention. An effect evaluation and a process evaluation are being conducted. The primary outcomes of the effect evaluation are self-efficacy expectancies, perceived control, and cognitive symptom management. The secondary outcome measures are smoking and drinking behaviour, Body Mass Index (BMI), physical activity level, self-care behaviour, health-related quality of life, perceived autonomy, symptoms of anxiety and depression, and health care utilisation. The programme's feasibility is assessed by measuring compliance with the protocol, patients' attendance and adherence, and the opinions about the programme.
Discussion:
A total number of 318 patients were included in the trial. At present, follow-up data are being collected. The results of the trial become clear after completion of the data collection in January 2007.
Trial Registration:
Trialregister (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=467) ISRCTN88363287.
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