- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06060223
Teach Back Method in Individuals With Heart Failure
The Effect of Teach Back Method on Symptom Control, Treatment Compliance and Self-Care Behaviors in Individuals With Heart Failure
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Amasya
-
Merkez, Amasya, Turkey, 05100
- Amasya University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teach Back Method
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.
|
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.
|
|
No Intervention: Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morsky Treatment Compliance Scale (MTUÖ-8)
Time Frame: 3 months
|
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.
|
3 months
|
|
European Heart Failure Self-Care Behavior Scale-12
Time Frame: 3 months
|
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.
|
3 months
|
|
Heart Failure Symptom Status Scale
Time Frame: 3 months
|
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.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Neşe Uysal, Amasya U
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AmasyaU-TG-777
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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