Evaluation of a self-management programme for congestive heart failure patients: design of a randomised controlled trial.
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
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.


CONCLUSIONS
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.


BACKGROUND
Trialregister (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=467) ISRCTN88363287.
Smeulders
Esther S T F
ES
Maastricht University, Faculty of Health Sciences, Department of Health Care Studies, P.O. Box 616, 6200 MD Maastricht, The Netherlands. e.smeulders@zw.unimaas.nl
van Haastregt
Jolanda C M
JC
van Hoef
Elisabeth F M
EF
van Eijk
Jacques Th M
JT
Kempen
Gertrudis I J M
GI
D000328:Adult; D016507:Cardiology Service, Hospital; D002908:Chronic Disease; D015928:Cognitive Behavioral Therapy; D006333:Heart Failure / Q000517:prevention & control* / Q000523:psychology; D006801:Humans; D008875:Middle Aged; D009426:Netherlands; D010044:Outpatient Clinics, Hospital; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D015397:Program Evaluation / Q000379:methods*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012648:Self Care / Q000379:methods*; D020377:Self Efficacy