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
| ISRCTN | ISRCTN88363287 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88363287 |
| Secondary identifying numbers | NHS, number 2002B005; NTR467 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 14/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Esther STF Smeulders
Scientific
Scientific
University Maastricht
Faculty of Health Sciences
Department of Health Care Studies Section of Medical Sociology
PO Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3884183 |
|---|---|
| E.Smeulders@ZW.unimaas.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 |
| Study objectives | 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 |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Congestive heart failure |
| 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. Lifestyle b. Physical activity level c. Self-care behavior (European Heart Failure Self-Care Behavior Scale) 3. Health care utilization (number of 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. |
| Overall study start date | 15/12/2003 |
| Completion date | 15/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 318 |
| Key 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 of 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 |
| Key exclusion criteria | Participation in other scientific research |
| Date of first enrolment | 15/12/2003 |
| Date of final enrolment | 15/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Maastricht
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
CAPHRI, The Research Institute of the University Maastricht (The Netherlands)
Not defined
Not defined
PO Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3882446 |
|---|---|
| e.habets@caphri.unimaas.nl | |
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
Research organisation
Netherlands Heart Foundation (Nederlandse Hartstichting), University Hospital Maastricht
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/07/2006 | Yes | No | |
| Results article | results | 01/11/2010 | Yes | No |
Editorial Notes
14/09/2017: Publication reference added.
