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

NCT04228120 | Completed

• 1 other identifier: CGH-P103008
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

Self-care behaviour; Self-regulation; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in quality of life scores

  4 weeks and 8 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

routine care

Interventions

self-regulation programme BEHAVIORAL

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.

intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

MeSH Terms

Conditions

Heart Failure; Self-Control

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Study Officials

• Ai-Fu Chiou, Ph.D

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 14, 2020
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share