The Effects of a Self-regulation Program on Self-care Behaviour in Patients With Heart Failure: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 82
- Primary Endpoint
- Changes in three self-care behaviour subscale scores
Study Overview
Brief Summary
This RCT study aims to examine the effects of a self-regulation programme on the self-care behaviour and quality of life of patients with heart failure. The following hypothesis was tested: Heart failure patients who receive the self-regulation program will report significant improvements in self-care behaviours after four weeks of the self-regulation programme. In contrast, patients in the control group showed no significant differences.
Detailed Description
Eight two patients with heart failure were randomly assigned into the intervention (n = 41) or control group (n = 41). The intervention group participated in a 4-week self-regulation programme, including 20 to 30 minutes of individual self-regulation education and 15 to 20 minutes of telephone follow-up twice per week for four weeks. The control group received only routine outpatient care. Self-care behaviour was measured by the Self-Care of Heart Failure Index at baseline, 4 weeks and 8 weeks after patients were enrolled. Quality of life was measure with the Minnesota Living with Heart Failure questionnaire
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged 20 years or older with heart failure diagnosed by a cardiologist (ICD-9:428)
- •willing to communicate and participate in this study
- •had clear consciousness
Exclusion Criteria
- •a diagnosis of cancer
- •a diagnosis of mental illness including anxiety and depression
- •had cognitive impairment
- •a diagnosis of lung disease, such as asthma or chronic obstructive pulmonary disease
- •a diagnosis of renal failure
Outcomes
Primary Outcomes
Changes in three self-care behaviour subscale scores
Time Frame: 4 weeks and 8 weeks
Changes from baseline Self-Care of Heart Failure Index (version 6.2) with three subscales: self-care maintenance, self-care management, and self-care confidence, at 4 weeks and 8 weeks. Each subscale score ranges from 0 to 100, with higher scores indicating better self-care behaviour.
Secondary Outcomes
- Change in quality of life scores(4 weeks and 8 weeks)
Investigators
Ai-Fu Chiou
Professor
National Yang Ming Chiao Tung University