End Stage Renal Disease on DialysisNCT05978479
The Effect of Individualized Education Using the Teach-Back Method Treatment on Treatment Adherence and the Coping Skills
A study testing Teach-Back Method in people with End Stage Renal Disease on Dialysis, run by Saglik Bilimleri Universitesi.
Trial summary
This study was planned to evaluate the effect of individual education given to adult patients with End Stage Renal Disease receiving hemodialysis treatment, using the Roy Adaptation Model-Based Teach Back Method under the guidance of nurses, on their ability to cope with fluid, diet and medication compliance and their… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Teach-Back Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 4 Sep 2023to 8 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodialysis treatment for 4 hours, three times a week for at least 3 months with a diagnosis of end-stage renal failure,
- Individuals between the ages of 18 and 65 years,
- Having no speech, vision or hearing problems,
- Be able to speak, read and write in Turkish,
- Patients who have voluntarily to participate and informed consent form in the study.
Who cannot join
- Those who do not participate or agree to participate in training,
- The general situation is not suitable for questioning,
- Those diagnosed with a cognitive disease such as dementia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Individualized Education Using the Teach-Back Method Based on Roy's Adaptation Model Given to Patients With End-Stage Renal Disease Receiving Hemodialysis Treatment on Treatment Adherence and the Coping Skills
This study was planned to evaluate the effect of individual education given to adult patients with End Stage Renal Disease receiving hemodialysis treatment, using the Roy Adaptation Model-Based Teach Back Method under the guidance of nurses, on their ability to cope with fluid, diet and medication compliance and their adaptation skills.
Read the detailed description
The study is a randomized, controlled, two-group intervention trial with pretest-posttest design at three centers. The study will enroll adult End Stage Renal Disease patients receiving hemodialysis treatment who meet the inclusion criteria at the three centers where the study is being conducted. Data for the study will be collected using face-to-face interviews, a patient information form, a hemodialysis treatment information form, the End-Stage Renal Disease Adherence Questionnaire, a Coping and Adaptation Processing Scale, and a "Teach Back Method" questionnaire. Patients participating in the study will receive an educational booklet that will be completed after obtaining expert opinion based on the literature from the researcher. Patients in the intervention group will be trained by the researcher using the "Teach Back Method" in three sessions. Each session will last 45-60 minutes. From the 2nd week of the study, patients' questions will be answered and a 15-minute retraining session will be made in every two weeks. Patients in the control group will undergo a pretest and a posttest, and their routine care and treatment will continue. At the end of the study, patients in the control group will take training booklets.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Teach-Back Method
- Keywords
- Hemodialysis, End-stage renal failure, Treatment adherence, Fluid and dietary restrictions, Teach-Back Method
- Medical subject headings
- Kidney Failure, Chronic, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-Back MethodOther
Also called Control group
No intervention will be given to the patients in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Teach-Back Method | Experimental | The intervention group will be trained using the Teach Back Method in 3 sessions on every other day that will last 45-60 minutes. Training topics are hemodialysis treatment, end stage renal failure, fluid and diet restrictions and their importance, medication adherence and its importance and lifestyle rules. At the same time, patients will take education booklets. Receives: Other: Teach-Back Method |
| Control group | No intervention | No intervention will be given to the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of education conducted with the "Teach Back Method" on treatment adherence
In hemodialysis patients,conditions such as dialysis treatment,medication,fluid and diet intake should be applied in harmony with the patient's life.The effect of educating patients in the intervention group with the "Teach Back Method" on the End-Stage Renal Disease Adherence Questionnaire and treatment adherence is evaluated.The End-Stage Renal Disease Adherence Scale is a scale that evaluates the patients' participation in hemodialysis treatment,their use of medication,their compliance with diet and fluid restriction.The validity and reliability of the scale were based on 9 items.The total score that can be obtained from 6 items varies between 0-1200.As the score obtained from the scale increases,the level of adherence to treatment increases.Compliance with scale hemodialysis treatment;It is a valid and reliable self-report tool that evaluates participation in hemodialysis treatment in all areas,including drug use,compliance with diet and fluid restriction.
Measured: Twelve weeks
The effects of the Teach Back Method education on coping with and adaptation to hemodialysis treatment.
This study evaluates the effect of training received by patients in the intervention group using the "Teach Back Method" with Coping and Adaptation Processing Scale to cope with and adaptate to hemodialysis treatment.
The scale consists of 47 items and 5 sub-dimensions. Scale sub-dimensions; Solution Finding and Focusing, Physical and Decision Making, Attention Process, Systematizing Process, and Learning and Relationship Building. Scale items are of 4-point Likert type. While calculating the Coping and Adaptation Scale score, it is obtained by summing the numerical values of the answers given for each item (reverse scoring is done for the Physical and Decision Making sub-dimension). The total score that can be obtained from the scale varies between 47-188. An increase in the score obtained from the scale is interpreted as more effective coping methods are used.
Measured: Twelve weeks
The effectiveness of using the Teach Back Method in hemodialysis patients
The effectiveness of the training for patients in the intervention group will be evaluated every two weeks using the "Teach Back Method" questionnaire.
In order to evaluate the knowledge, behaviors and skills acquired by the patients during the follow-ups, the Tell What You Have Learned Questionnaire, prepared by the researcher in line with the literature will be used. The Tell What You Have Learned Questionnaire consists of topics including drug therapy, interdialytic weight gain, diet management, fluid consumption, symptom management and physical activity. The Tell What You Have Learned Questionnaire consists of a total of 18 questions, one for each measuring knowledge, behavior and skill for each subject. Patients are expected to answer correctly at least 75 percent of the questions about knowledge, behavior and skill learning areas.
Measured: Ten weeks
Secondary outcomes (4)
The Effect of the Training given with the Teach Back Method on Interdialytic Weight
The effect of the individual training given with the teach-back method on the difference between the weight measured before and after dialysis will be examined.
Measured: Twelve weeks
The effect of training given with the Teach-Back Method on the amount of ultrafiltration
The effect of the training given with the teach-back method on the amount of ultrafiltration will be examined.
The amount of ultrafiltration is an objective measure of how the patient manages and adheres to fluid intake. The amount of ultrafiltration can be defined as the difference between the weight measured after the previous dialysis and the weight measured before the current dialysis application. A high amount of ultrafiltration indicates poor compliance with liquid restrictions. As an indicator of compliance for liquid restriction, it is desirable that the amount of ultrafiltration be between 3-5% of dry weight or below 4-4.5%.
Measured: Twelve weeks
The effect of training given with the Teach Back Method on arterial blood pressure
The effect of training given with the teach-back method on arterial blood pressure will be examined.
Measured: Twelve weeks
The effect of training given with the Teach Back Method on dialysis adequacy (Kt/V)
The effect of individual training given with the teach-back method on dialysis adequacy will be examined.
Dialysis adequacy; It refers to the dialysis dose measured by solute removal, which includes all functions of the kidney. Adequate dialysis is the dialysis dose in which there are no uremic symptoms, biochemical parameters are within the normal range, and one feels good mentally and psychologically. Dialysis adequacy should be evaluated by clinical evaluation, laboratory findings and kinetic indicators. Kt/V; It is calculated by multiplying the urea clearance of the dialyzer by the dialysis time and dividing by the urea distribution volume. It will be taken from the patient file. The target Kt/V for hemodialysis should be between 1.2 and 1.4.
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start4 Sep 2023 (estimated)
- Primary completion8 Dec 2023 (estimated)
- Study completion8 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies 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
- Model description
- Patients in the intervention group (experimental group) will receive a hemodialysis training booklet and face-to-face training using the "Teach Back Method" in three sessions held every other day. The routine care and treatment of the control group will be continued.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ELIF ACAR, Saglik Bilimleri Universitesi
- Investigators
- Elif Acar, Msc., Principal investigator, University of Health scienceSemiha Akın, Prof., Principal investigator, University of Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978479
- Sponsor's protocol ID
- SaglikBilimleriUEACAR0001
- Status last verified
- Jul 2023
- First submitted
- 1 May 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualized Education Using the Teach-Back Method Based on Roy's Adaptation Model Given to Patients With End-Stage Renal Disease Receiving Hemodialysis Treatment on Treatment Adherence and the Coping Skills
- ClinicalTrials.gov ID
- NCT05978479
- Acronym / sponsor ID
- SaglikBilimleriUEACAR0001
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- Hemodialysis, End-stage renal failure, Treatment adherence, Fluid and dietary restrictions, Teach-Back Method
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 4 Sep 2023 (estimated)
- Primary completion
- 8 Dec 2023 (estimated)
- Study completion
- 8 Dec 2023 (estimated)
- First posted
- 7 Aug 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 was planned to evaluate the effect of individual education given to adult patients with End Stage Renal Disease receiving hemodialysis treatment, using the Roy Adaptation Model-Based Teach Back Method under the guidance of nurses, on their ability to cope with fluid, diet and medication compliance and their adaptation skills.
Detailed description
The study is a randomized, controlled, two-group intervention trial with pretest-posttest design at three centers. The study will enroll adult End Stage Renal Disease patients receiving hemodialysis treatment who meet the inclusion criteria at the three centers where the study is being conducted. Data for the study will be collected using face-to-face interviews, a patient information form, a hemodialysis treatment information form, the End-Stage Renal Disease Adherence Questionnaire, a Coping and Adaptation Processing Scale, and a "Teach Back Method" questionnaire. Patients participating in the study will receive an educational booklet that will be completed after obtaining expert opinion based on the literature from the researcher. Patients in the intervention group will be trained by the researcher using the "Teach Back Method" in three sessions. Each session will last 45-60 minutes. From the 2nd week of the study, patients' questions will be answered and a 15-minute retraining session will be made in every two weeks. Patients in the control group will undergo a pretest and a posttest, and their routine care and treatment will continue. At the end of the study, patients in the control group will take training booklets.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in the intervention group (experimental group) will receive a hemodialysis training booklet and face-to-face training using the "Teach Back Method" in three sessions held every other day. The routine care and treatment of the control group will be continued.
| Arm | Type | Receives |
|---|---|---|
| Teach-Back Method | Experimental | Other: Teach-Back MethodThe intervention group will be trained using the Teach Back Method in 3 sessions on every other day that will last 45-60 minutes. Training topics are hemodialysis treatment, end stage renal failure, fluid and diet restrictions and their importance, medication adherence and its importance and lifestyle rules. At the same time, patients will take education booklets. |
| Control group | No intervention | –No intervention will be given to the patients in the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hemodialysis treatment for 4 hours, three times a week for at least 3 months with a diagnosis of end-stage renal failure,
- Individuals between the ages of 18 and 65 years,
- Having no speech, vision or hearing problems,
- Be able to speak, read and write in Turkish,
- Patients who have voluntarily to participate and informed consent form in the study.
Key exclusion criteria (3 listed)
- Those who do not participate or agree to participate in training,
- The general situation is not suitable for questioning,
- Those diagnosed with a cognitive disease such as dementia.
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 MethodAlso: Control groupNo intervention will be given to the patients in the control group. | Other | Teach-Back Method |
Primary outcome
Effect of education conducted with the "Teach Back Method" on treatment adherence
Time frame: Twelve weeks
In hemodialysis patients,conditions such as dialysis treatment,medication,fluid and diet intake should be applied in harmony with the patient's life.The effect of educating patients in the intervention group with the "Teach Back Method" on the End-Stage Renal Disease Adherence Questionnaire and treatment adherence is evaluated.The End-Stage Renal Disease Adherence Scale is a scale that evaluates the patients' participation in hemodialysis treatment,their use of medication,their compliance with diet and fluid restriction.The validity and reliability of the scale were based on 9 items.The total score that can be obtained from 6 items varies between 0-1200.As the score obtained from the scale increases,the level of adherence to treatment increases.Compliance with scale hemodialysis treatment;It is a valid and reliable self-report tool that evaluates participation in hemodialysis treatment in all areas,including drug use,compliance with diet and fluid restriction.
The effects of the Teach Back Method education on coping with and adaptation to hemodialysis treatment.
Time frame: Twelve weeks
This study evaluates the effect of training received by patients in the intervention group using the "Teach Back Method" with Coping and Adaptation Processing Scale to cope with and adaptate to hemodialysis treatment. The scale consists of 47 items and 5 sub-dimensions. Scale sub-dimensions; Solution Finding and Focusing, Physical and Decision Making, Attention Process, Systematizing Process, and Learning and Relationship Building. Scale items are of 4-point Likert type. While calculating the Coping and Adaptation Scale score, it is obtained by summing the numerical values of the answers given for each item (reverse scoring is done for the Physical and Decision Making sub-dimension). The total score that can be obtained from the scale varies between 47-188. An increase in the score obtained from the scale is interpreted as more effective coping methods are used.
The effectiveness of using the Teach Back Method in hemodialysis patients
Time frame: Ten weeks
The effectiveness of the training for patients in the intervention group will be evaluated every two weeks using the "Teach Back Method" questionnaire. In order to evaluate the knowledge, behaviors and skills acquired by the patients during the follow-ups, the Tell What You Have Learned Questionnaire, prepared by the researcher in line with the literature will be used. The Tell What You Have Learned Questionnaire consists of topics including drug therapy, interdialytic weight gain, diet management, fluid consumption, symptom management and physical activity. The Tell What You Have Learned Questionnaire consists of a total of 18 questions, one for each measuring knowledge, behavior and skill for each subject. Patients are expected to answer correctly at least 75 percent of the questions about knowledge, behavior and skill learning areas.
4 secondary outcomes
The Effect of the Training given with the Teach Back Method on Interdialytic Weight
Time frame: Twelve weeks
The effect of training given with the Teach-Back Method on the amount of ultrafiltration
Time frame: Twelve weeks
The effect of training given with the Teach Back Method on arterial blood pressure
Time frame: Twelve weeks
The effect of training given with the Teach Back Method on dialysis adequacy (Kt/V)
Time frame: Twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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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.
Elif Acar, Msc. principal investigator
University of Health science
Semiha Akın, Prof. principal investigator
University of Health science
Questions about this trial
What is this clinical trial studying?
A study testing Teach-Back Method in people with End Stage Renal Disease on Dialysis, run by Saglik Bilimleri Universitesi.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Acar, Msc. (+905052623723, elifuacar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of education conducted with the "Teach Back Method" on treatment adherence (time frame: Twelve weeks). 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 7 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.