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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228120
• Other study ID #: CGH-P103008
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2024
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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