Contact information
Type
Scientific
Primary contact
Dr Esther STF Smeulders
ORCID ID
Contact details
University Maastricht
Faculty of Health Sciences
Department of Health Care Studies Section of Medical Sociology
PO Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3884183
E.Smeulders@ZW.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NHS, number 2002B005; NTR467
Study information
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
Acronym
Study 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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
15/12/2003
Overall trial end date
15/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
318
Participant exclusion criteria
Participation in other scientific research
Recruitment start date
15/12/2003
Recruitment end date
15/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Maastricht
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
CAPHRI, The Research Institute of the University Maastricht (The Netherlands)
Sponsor details
PO Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882446
e.habets@caphri.unimaas.nl
Sponsor type
Not defined
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Heart Foundation (Nederlandse Hartstichting), University Hospital Maastricht
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/16857049
2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20153132
Publication citations
-
Results
Smeulders ES, van Haastregt JC, van Hoef EF, van Eijk JT, Kempen GI, Evaluation of a self-management programme for congestive heart failure patients: design of a randomised controlled trial., BMC Health Serv Res, 2006, 6, 91, doi: 10.1186/1472-6963-6-91.