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

National Yang Ming Chiao Tung University

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: self-regulation programme

Study type: Interventional

Funder types: Other

Identifiers

NCT04228120

CGH-P103008

Details and patient eligibility

About

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.

Full 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

Enrollment: 82 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: self-regulation programme

control group

No Intervention group

Description:

routine care