Condition category
Circulatory System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
04/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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

Not Specified

Gender

Not Specified

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

Results - basic reporting

Publication summary

Design in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16857049

Publication citations

  1. Design

    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.

Additional files

Editorial Notes