Skip to main content
Clinical Trials/NCT04228120
NCT04228120
Completed
Not Applicable

The Effects of a Self-regulation Program on Self-care Behaviour in Patients With Heart Failure: A Randomized Controlled Trial

National Yang Ming Chiao Tung University0 sites82 target enrollmentJanuary 2015
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
National Yang Ming Chiao Tung University
Enrollment
82
Primary Endpoint
Changes in three self-care behaviour subscale scores
Status
Completed
Last Updated
2 years ago

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

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
September 2015
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ai-Fu Chiou

Professor

National Yang Ming Chiao Tung University

Eligibility Criteria

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)

Similar Trials