Effects of a Self-regulation Program on Self-care Behaviour of Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: self-regulation programme

• Registration Number: NCT04228120
• Lead Sponsor: National Yang Ming Chiao Tung University

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-11
• Study First Posted: 2020-01-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	self-regulation programme	The programme consisted of one 20-to-30-minute, face-to-face individual education session related to self-regulation and problem-solving processes that was performed in accordance with the patient's plan. Furthermore, eight 15- to 20-minute telephone follow-up counselling sessions were delivered twice per week for four weeks.

Primary Outcome Measures

Name	Time	Method
Changes in three self-care behaviour subscale scores	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 Outcome Measures

Name	Time	Method
Change in quality of life scores	4 weeks and 8 weeks	Change from baseline Minnesota Living with Heart failure questionnaire scores at 4 weeks and 8 weeks. The total score range is 0-105; a higher score indicates lower quality of life.