No registrations found.
ID
Source
Brief title
Health condition
Congestive heart failure
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. 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 outcome
1. 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.
Background summary
This 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.
Study objective
1. 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.
Study design
N/A
Intervention
1. 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.
P.O. Box 616
Esther S.T.F. Smeulders
Maastricht 6200 MD
The Netherlands
+31 (0)43 3884183
E.Smeulders@ZW.unimaas.nl
P.O. Box 616
Esther S.T.F. Smeulders
Maastricht 6200 MD
The Netherlands
+31 (0)43 3884183
E.Smeulders@ZW.unimaas.nl
Inclusion criteria
1. 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 criteria
Participation in other scientific research.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL427 |
| NTR-old | NTR467 |
| Other | : NHS, nr. 2002B005 |
| ISRCTN | ISRCTN88363287 |