Heart FailureNCT06060223
Teach Back Method in Individuals With Heart Failure
A study testing Teach Back Method in people with Heart Failure, run by Amasya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Teach Back Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2022to 14 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- under 18 years old
- Patients with cognitive dysfunction
- Those with neuro-psychiatric disease
- Those who did not consent to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Teach Back Method on Symptom Control, Treatment Compliance and Self-Care Behaviors in Individuals With Heart Failure
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Teach Back Method
- Keywords
- patient, education
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach Back MethodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Teach Back Method | Experimental | 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. Receives: Other: Teach Back Method |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start3 Oct 2022
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neşe Uysal, Study director, Amasya U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060223
- Sponsor's protocol ID
- AmasyaU-TG-777
- Status last verified
- Feb 2024
- First submitted
- 23 Sep 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Teach Back Method on Symptom Control, Treatment Compliance and Self-Care Behaviors in Individuals With Heart Failure
- ClinicalTrials.gov ID
- NCT06060223
- Acronym / sponsor ID
- AmasyaU-TG-777
- Conditions
- Heart Failure
- Keywords
- patient, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teach Back Method | Experimental | Other: Teach Back MethodTraining 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- under 18 years old
- Patients with cognitive dysfunction
- Those with neuro-psychiatric disease
- Those who did not consent to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teach Back MethodTraining 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. | Other | Teach Back Method |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 3
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neşe Uysal study director
Amasya U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach Back Method in people with Heart Failure, run by Amasya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morsky Treatment Compliance Scale (MTUÖ-8) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.