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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04228120
Recruitment Status : Completed
First Posted : January 14, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ai-Fu Chiou, National Yang Ming University

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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: self-regulation programme Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of a Self-regulation Program on Self-care Behaviour in Patients With Heart Failure: A Randomized Controlled Trial
Actual Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: control group
routine care



Primary Outcome Measures :
  1. Changes in three self-care behaviour subscale scores [ Time Frame: 4 weeks and 8 weeks ]
    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 :
  1. Change in quality of life scores [ Time Frame: 4 weeks and 8 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228120


Sponsors and Collaborators
National Yang Ming University
Investigators
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Principal Investigator: Ai-Fu Chiou, Ph.D Professor

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Responsible Party: Ai-Fu Chiou, Professor, National Yang Ming University
ClinicalTrials.gov Identifier: NCT04228120    
Other Study ID Numbers: CGH-P103008
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ai-Fu Chiou, National Yang Ming University:
Self-care behaviour
Self-regulation
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases