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
Protocol serial number	NHS, number 2002B005; NTR467
Sponsor	CAPHRI, The Research Institute of the University Maastricht (The Netherlands)
Funder	Netherlands Heart Foundation (Nederlandse Hartstichting), University Hospital Maastricht

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

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
Email	E.Smeulders@ZW.unimaas.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	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.
Completion date	15/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2010		Yes	No
Protocol article	protocol	20/07/2006		Yes	No

Editorial Notes

14/09/2017: Publication reference added.