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

National Yang Ming Chiao Tung University82 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

self-regulation programmeBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

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.

Time frame: 4 weeks and 8 weeks

Secondary Outcomes

Change in quality of life scores

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.

Time frame: 4 weeks and 8 weeks

Data from ClinicalTrials.gov

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