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

NCT ID: NCT04228120

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-09-30

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

self-regulation programme

Intervention Type: 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.

control group

routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Ai-Fu Chiou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ai-Fu Chiou, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Professor

Other Identifiers

CGH-P103008

Identifier Type: -

Identifier Source: org_study_id