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Self-management and congestive heart failure: a randomized controlled trial to improve health-behavior and health-related quality of life by increasing self-efficacy expectancies in congestive heart failure patients.


- candidate number1780
- NTR NumberNTR467
- ISRCTNISRCTN88363287
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR21-okt-2005
- Secondary IDsNHS, nr. 2002B005 
- Public TitleSelf-management and congestive heart failure: a randomized controlled trial to improve health-behavior and health-related quality of life by increasing self-efficacy expectancies in congestive heart failure patients.
- Scientific TitleSelf-management and congestive heart failure: a randomized controlled trial to improve health-behavior and health-related quality of life by increasing self-efficacy expectancies in congestive heart failure patients.
- ACRONYMN/A
- hypothesis1. Self-efficacy expectancies may increase by the "Chronic Disease Self-Management Program" in congestive heart failure intervention patients as compared to controls;
2. These higher levels of self-efficacy expectancies contribute to health behavior, and will decrease demoralization (depressive symptoms, feelings of anxiety) and functional disability and increase levels of quality of life.
- Healt Condition(s) or Problem(s) studiedCongestive heart failure
- Inclusion criteria1. Extent of congestive heart failure (CHF): systolic CHF; LVEF<40% (NYHA 2-3) or diastolic CHF (NYHA 2-3 + additional hospital admission ‘Decompensatio Cordis’ after being diagnosed with CHF);
2. Diagnosis CHF at least 3 months ago to include only stable patients (an additional 3 months before the start of the intervention sums up to 6 months);
3. Ability to understand/write/speak Dutch.
- Exclusion criteriaParticipation in other scientific research.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-dec-2003
- planned closingdate15-dec-2007
- Target number of participants360
- Interventions1. Patients in the intervention group attend a protocolled self-management group course (6 weekly sessions of 2,5 hours per session);
2. Patients assigned to the control group received usual care.
- Primary outcome1. Self-efficacy expectancies:
a. General expectancies: General Self-Efficacy Scale (GSES);
b. Cardiac expectancies by scale Sullivan et al. (1998);
2. Perceived control/ mastery by Mastery scale (Pearlin & Schooler 1978).
- Secondary outcome1. Quality of life:
a. General: RAND/SF-36;
b. CHF-specific: Kansas City Cardiomyopathy Questionnaire (KCCQ);
c. Symptoms of anxiety/ depression: Hospital Anxiety & Depression Scale (HADS);
2. Health behavior:
a. Life style;
b. Physical activity level;
c. Self-care behavior (European Heart Failure Self-Care Behavior Scale);
3. Health care utilization (number consultations of cardiologist/ nurse specialist, hospitalization days etc.)

In addition, the following variables are assessed with respect to the process evaluation: performance according to protocol, attendance, overall adherence per course session/ adherence with regard to home work assignments, opinions about the intervention (participants + course leaders) etc.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMSc. Esther S.T.F. Smeulders
- CONTACT for SCIENTIFIC QUERIESProf. PhD. G.I.J.M. Kempen
- Sponsor/Initiator University Maastricht (UM), CAPHRI Research Institute
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Heart Foundation (NHS, Nederlandse Hartstichting), University Hospital Maastricht (AZM)
- PublicationsN/A
- Brief summaryThis study comprises both an effect and a process evaluation of the into Dutch translated "Chronic Disease Self-Management Program" among congestive heart failure patients. The self-management course, developed by Lorig and colleagues (Stanford University), has been broadly evaluated and implemented in the USA. In the present study the course is led by 2 trained course leaders (nurse specialist + congestive heart failure patient). Effectiveness of the Dutch version among congestive heart failure patients is assessed in a RCT-design with 1-year follow-up.
- Main changes (audit trail)
- RECORD21-okt-2005 - 18-jan-2010


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