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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
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    January 9, 2020
    Last Updated
    January 14, 2020
    Sponsor
    National Yang Ming University
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    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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