Effects of a Self-regulation Program on Self-care Behaviour of Heart Failure Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
self-regulation programme
Sponsored by

About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Self-care behaviour, Self-regulation, Heart Failure
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm 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.
routine care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04228120
First Posted
January 9, 2020
Last Updated
January 14, 2020
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT04228120
Brief Title
Effects of a Self-regulation Program on Self-care Behaviour of Heart Failure Patients
Official Title
The Effects of a Self-regulation Program on Self-care Behaviour in Patients With Heart Failure: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Self-care behaviour, Self-regulation, Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
routine care
Intervention Type
Behavioral
Intervention Name(s)
self-regulation programme
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in three self-care behaviour subscale scores
Description
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.
Time Frame
4 weeks and 8 weeks
Secondary Outcome Measure Information:
Title
Change in quality of life scores
Description
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.
Time Frame
4 weeks and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ai-Fu Chiou, Ph.D
Organizational Affiliation
Professor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of a Self-regulation Program on Self-care Behaviour of Heart Failure Patients
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