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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29524
Enrollment
360
Registered
2005-10-21
Start date
2003-12-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive heart failure

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.

Sponsors

CAPHRI, The Research Institute of the University Maastricht
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Participation in other scientific research.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Contacts

Public ContactEsther S.T.F. Smeulders

University Maastricht (UM), Faculty of Health Sciences, Department of Health Care Studies, Section of Medical Sociology, P.O. Box 616

E.Smeulders@ZW.unimaas.nl+31 (0)43 3884183

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)