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Teach-Back Method on Quality of Life in Heart Failure Patients

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education with Teach-Back method
Received routine treatment
Sponsored by
Baqiyatallah Medical Sciences 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, Heart Failure, Quality of Life, Teach-Back

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age from 45 to 85
  • Heart failure diagnosed six months ago
  • The Ejection Fraction less than 45
  • Have reading and writing skills
  • Have perfect consciousness
  • Fluency in Persian

Exclusion Criteria:

  • Patient do not cooperate with researchers
  • The inability of each sample to continue cooperation during the study because of the problem or acute disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Test group

    Control group

    Arm Description

    Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the Test group

    The control group received routine treatment

    Outcomes

    Primary Outcome Measures

    SF 36 questionnaire
    SF36 questionnaire was used to measuring the quality of life
    Demographic questionnaire
    Demographic questionnaire was used to collect information

    Secondary Outcome Measures

    Full Information

    First Posted
    June 25, 2018
    Last Updated
    July 20, 2018
    Sponsor
    Baqiyatallah Medical Sciences University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03596359
    Brief Title
    Teach-Back Method on Quality of Life in Heart Failure Patients
    Official Title
    Effect of Self-care Education With Teach-Back Method on Quality of Life in Heart Failure Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 18, 2016 (Actual)
    Primary Completion Date
    March 2, 2017 (Actual)
    Study Completion Date
    May 20, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baqiyatallah Medical Sciences University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study determines effect of education with Teach-Back method in patients with Heart failure. In this randomized clinical trial, 70 patients with Heart failure hospitalized in year 2016-17 were selected and they were randomly divided into control group and test group.Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the case group, and control group received routine treatment. Information have collected whit Demographic questionnaire and SF36 questionnaire before and after training. Data were analyzed by Spss version18 And there were analyzed by descriptive statistics and Chi-square, Independent T-test, Paired T-test and Co-variance tests.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Self Care, Heart Failure, Quality of Life, Teach-Back

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test group
    Arm Type
    Experimental
    Arm Description
    Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the Test group
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The control group received routine treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Education with Teach-Back method
    Intervention Type
    Other
    Intervention Name(s)
    Received routine treatment
    Primary Outcome Measure Information:
    Title
    SF 36 questionnaire
    Description
    SF36 questionnaire was used to measuring the quality of life
    Time Frame
    Up to 48 hours
    Title
    Demographic questionnaire
    Description
    Demographic questionnaire was used to collect information
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age from 45 to 85 Heart failure diagnosed six months ago The Ejection Fraction less than 45 Have reading and writing skills Have perfect consciousness Fluency in Persian Exclusion Criteria: Patient do not cooperate with researchers The inability of each sample to continue cooperation during the study because of the problem or acute disease.

    12. IPD Sharing Statement

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