Abstract
BackgroundCongestive 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/DesignThe 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.DiscussionA 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 RegistrationTrialregister () ISRCTN88363287.
Highlights
Congestive heart failure (CHF) has a substantial impact on care utilisation and quality of life
The current paper presents the design of a multi-centre randomised controlled trial evaluating the Chronic Disease Self-Management Program' (CDSMP) among CHF outpatients in the south of the Netherlands
Patients were eligible for the study if they met the following four criteria: (1) having been diagnosed with CHF based on a systolic dysfunction (left ventricular ejection fraction (LVEF) < 40% with New York Heart Association (NYHA) Class II-III symptoms; slight to marked limitation of physical activity) or a diastolic dysfunction (LVEF ≥ 40% with NYHA Class II-III symptoms plus an additional hospital admission based on decompensatio cordis after CHF diagnosis); (2) having been a CHF patient for at least six months at the start of the intervention period, (3) being able to understand, write, and speak Dutch, and (4) being willing to give informed consent to participate in the study
Summary
Progress of the study Between July 2004 and November 2005, a total of 717 eligible patients were selected for inclusion from six Heart Failure and/or Cardiology Outpatient Clinics, 339 of whom (47.3%) signed the informed consent form and underwent the baseline assessment (see figure 2). After completion of the baseline assessment, 318 patients were included in the trial; 187 patients were allocated to the intervention group and 131 to the control group. We had calculated that the study would require a sample size of 2 × 180, including a 30% drop-out rate. A total of 187 patients were allocated to the intervention group, which was according to plan. The number of patients allocated to the control group (n = 131), was smaller than planned. The exact drop-out rate and related consequences for the power calculation will become clear after completion of the data collection in January 2007
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