|- candidate number||1780|
|- NTR Number||NTR467|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||21-okt-2005|
|- Secondary IDs||NHS, nr. 2002B005 |
|- Public Title||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.|
|- Scientific Title||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.|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Congestive heart failure|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-dec-2003|
|- planned closingdate||15-dec-2007|
|- Target number of participants||360|
|- Interventions||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.
|- 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.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc. Esther S.T.F. Smeulders|
|- CONTACT for SCIENTIFIC QUERIES||Prof. PhD. G.I.J.M. Kempen|
|- Sponsor/Initiator ||University Maastricht (UM), CAPHRI Research Institute|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting), University Hospital Maastricht (AZM)|
|- Brief 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. |
|- Main changes (audit trail)|
|- RECORD||21-okt-2005 - 18-jan-2010|