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Teach Back Method in Individuals With Heart Failure

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Teach Back Method
Sponsored by
Amasya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring patient, education

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals diagnosed with heart failure at least 6 months ago Individuals who speak and understand Turkish Able to communicate by phone İndividuals who can read and write Those who gave consent to participate in the research Exclusion Criteria: under 18 years old Patients with cognitive dysfunction Those with neuro-psychiatric disease Those who did not consent to participate in the research

Sites / Locations

  • Amasya UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Teach Back Method

Control

Arm Description

Training and consultancy services based on the teach-back method will be provided to individuals in the training group using the "Heart Failure Training Guide" in the form of 3 follow-ups in the cardiology clinic and telephone counseling. Telephone interviews were conducted by the researcher in the first week after discharge, it will be held in the first month and 3rd month. In addition, patients will receive counseling by calling the researcher if necessary.

Patients in the control group will participate in standard educational practices implemented in the clinic.Patients will be contacted by phone 3 months after discharge. Data collection forms will be applied as a final test.

Outcomes

Primary Outcome Measures

Morsky Treatment Compliance Scale (MTUÖ-8)
The scale consists of seven yes/no closed-ended questions with two options and one closed-ended question with five options. 1 point is given for answering no to questions one, two, three, four, six and seven, and 1 point is given for answering yes to question five. The eighth question consists of a multiple choice question called Likert type.A high score from the scale indicates high compliance with treatment.
European Heart Failure Self-Care Behavior Scale-12
The scale applied to measure the self-care behaviors of patients with heart failure has been determined as a scale that provides results in a short time, does not require separate training, and can be applied by the patients themselves. Identifying symptoms related to heart failure such as edema, respiratory distress, and fatigue; It is a Likert-type scale consisting of 12 questions that measures self-care assessment actions such as regular use of medications for these symptoms, fluid and salt restriction, communication with healthcare personnel, and weight monitoring.A high total score indicates low self-care, a low score indicates high self-care.
Heart Failure Symptom Status Scale
Developed by et al. aimed to evaluate the presence, frequency and severity of seven main symptoms, such as dyspnea during the day, dyspnea while lying down, fatigue, angina, edema, sleep problems, dizziness or loss of balance, which are the most common in HF patients, and to what extent each of them affects the patient.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2023
Last Updated
September 23, 2023
Sponsor
Amasya University
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1. Study Identification

Unique Protocol Identification Number
NCT06060223
Brief Title
Teach Back Method in Individuals With Heart Failure
Official Title
The Effect of Teach Back Method on Symptom Control, Treatment Compliance and Self-Care Behaviors in Individuals With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
October 16, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amasya 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 study will be conducted to determine the effect of the training given to indivuduals with heart failure by teach back method on their symptom control, adherence to treatment and self care behaviours.
Detailed Description
İntroduction: At least 40 million individuals worldwide live with heart failure. Although it is progressive, heart failure symptoms can be controlled through pharmacological treatment and self-care practices. The aim of heart failure treatment is to improve the quality of life of patients, prolong their lifespan, and prevent the progression of symptoms of the disease and re-admission to the hospital. Heart failure guidelines state that patient education and post-discharge follow-up are necessary for successful management of symptoms. Purpose:This study will be conducted to determine the effect of the training given to indivuduals with heart failure by teach back method on their symptom control, adherence to treatment and self care behaviours. Method:This study will be conducted using a randomized controlled research design. The research sample will consist of 58 with heart failure in the cardiology department of a training and research hospital. Research data will be collected using introductory information form, the Morsky Treatment Compliance Scale, European Heart Failure Self-Care Behavior Scale-12, Heart Failure Symptom Status Scale. Training and consultancy services based on the teach-back method will be provided to individuals in the training group using the "Heart Failure Training Guide" in the form of 3 follow-ups in the cardiology clinic and telephone counseling. Telephone interviews were conducted by the researcher in the first week after discharge, it will be held in the first month and 3rd month. In addition, patients will receive counseling by calling the researcher if necessary. After the patients are discharged, they will be called 1 week later, at the end of the 1st month and at the end of the 3rd month, and training will be repeated and counseling will be provided in line with the issues needed. Research posttest data will be collected 3 months after discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
patient, education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teach Back Method
Arm Type
Experimental
Arm Description
Training and consultancy services based on the teach-back method will be provided to individuals in the training group using the "Heart Failure Training Guide" in the form of 3 follow-ups in the cardiology clinic and telephone counseling. Telephone interviews were conducted by the researcher in the first week after discharge, it will be held in the first month and 3rd month. In addition, patients will receive counseling by calling the researcher if necessary.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control group will participate in standard educational practices implemented in the clinic.Patients will be contacted by phone 3 months after discharge. Data collection forms will be applied as a final test.
Intervention Type
Other
Intervention Name(s)
Teach Back Method
Intervention Description
Training and consultancy services based on the teach-back method will be provided to individuals in the training group using the "Heart Failure Training Guide" in the form of 3 follow-ups in the cardiology clinic and telephone counseling. Telephone interviews were conducted by the researcher in the first week after discharge, it will be held in the first month and 3rd month. In addition, patients will receive counseling by calling the researcher if necessary.
Primary Outcome Measure Information:
Title
Morsky Treatment Compliance Scale (MTUÖ-8)
Description
The scale consists of seven yes/no closed-ended questions with two options and one closed-ended question with five options. 1 point is given for answering no to questions one, two, three, four, six and seven, and 1 point is given for answering yes to question five. The eighth question consists of a multiple choice question called Likert type.A high score from the scale indicates high compliance with treatment.
Time Frame
3 months
Title
European Heart Failure Self-Care Behavior Scale-12
Description
The scale applied to measure the self-care behaviors of patients with heart failure has been determined as a scale that provides results in a short time, does not require separate training, and can be applied by the patients themselves. Identifying symptoms related to heart failure such as edema, respiratory distress, and fatigue; It is a Likert-type scale consisting of 12 questions that measures self-care assessment actions such as regular use of medications for these symptoms, fluid and salt restriction, communication with healthcare personnel, and weight monitoring.A high total score indicates low self-care, a low score indicates high self-care.
Time Frame
3 months
Title
Heart Failure Symptom Status Scale
Description
Developed by et al. aimed to evaluate the presence, frequency and severity of seven main symptoms, such as dyspnea during the day, dyspnea while lying down, fatigue, angina, edema, sleep problems, dizziness or loss of balance, which are the most common in HF patients, and to what extent each of them affects the patient.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals diagnosed with heart failure at least 6 months ago Individuals who speak and understand Turkish Able to communicate by phone İndividuals who can read and write Those who gave consent to participate in the research Exclusion Criteria: under 18 years old Patients with cognitive dysfunction Those with neuro-psychiatric disease Those who did not consent to participate in the research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tugba Gokce
Phone
(90)3582181767
Email
averreos.reis@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neşe Uysal
Organizational Affiliation
Amasya U
Official's Role
Study Director
Facility Information:
Facility Name
Amasya University
City
Merkez
State/Province
Amasya
ZIP/Postal Code
05100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuğba Gökce
Email
averreos.reis@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Teach Back Method in Individuals With Heart Failure

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