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

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
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
NCT ID
NCT03596359
First Posted
June 25, 2018
Last Updated
July 20, 2018
Sponsor
Baqiyatallah Medical Sciences University
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
Learn more about this trial
Teach-Back Method on Quality of Life in Heart Failure Patients
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