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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: self-regulation programme

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; routine care
Experimental: intervention group; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks and 8 weeks

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Principal Investigator: Ai-Fu Chiou, Ph.D, Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 11, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Self-regulation; Self-care behaviour
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CGH-P103008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No