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The Effect of Individualized Education Using the Teach-Back Method Treatment on Treatment Adherence and the Coping Skills

Primary Purpose

End Stage Renal Disease on Dialysis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Teach-Back Method
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End Stage Renal Disease on Dialysis focused on measuring Hemodialysis, End-stage renal failure, Treatment adherence, Fluid and dietary restrictions, Teach-Back Method

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Teach-Back Method

    Control group

    Arm Description

    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.

    No intervention will be given to the patients in the control group.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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%.
    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.
    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.

    Full Information

    First Posted
    May 1, 2023
    Last Updated
    July 29, 2023
    Sponsor
    Saglik Bilimleri Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05978479
    Brief Title
    The Effect of Individualized Education Using the Teach-Back Method Treatment on Treatment Adherence and the Coping Skills
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 4, 2023 (Anticipated)
    Primary Completion Date
    December 8, 2023 (Anticipated)
    Study Completion Date
    December 8, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Saglik Bilimleri Universitesi

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Renal Disease on Dialysis
    Keywords
    Hemodialysis, End-stage renal failure, Treatment adherence, Fluid and dietary restrictions, Teach-Back Method

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Teach-Back Method
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No intervention will be given to the patients in the control group.
    Intervention Type
    Other
    Intervention Name(s)
    Teach-Back Method
    Other Intervention Name(s)
    Control group
    Intervention Description
    No intervention will be given to the patients in the control group.
    Primary Outcome Measure Information:
    Title
    Effect of education conducted with the "Teach Back Method" on treatment adherence
    Description
    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.
    Time Frame
    Twelve weeks
    Title
    The effects of the Teach Back Method education on coping with and adaptation to hemodialysis treatment.
    Description
    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.
    Time Frame
    Twelve weeks
    Title
    The effectiveness of using the Teach Back Method in hemodialysis patients
    Description
    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.
    Time Frame
    Ten weeks
    Secondary Outcome Measure Information:
    Title
    The Effect of the Training given with the Teach Back Method on Interdialytic Weight
    Description
    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.
    Time Frame
    Twelve weeks
    Title
    The effect of training given with the Teach-Back Method on the amount of ultrafiltration
    Description
    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%.
    Time Frame
    Twelve weeks
    Title
    The effect of training given with the Teach Back Method on arterial blood pressure
    Description
    The effect of training given with the teach-back method on arterial blood pressure will be examined.
    Time Frame
    Twelve weeks
    Title
    The effect of training given with the Teach Back Method on dialysis adequacy (Kt/V)
    Description
    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.
    Time Frame
    Twelve weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elif Acar, Msc.
    Phone
    +905052623723
    Email
    elifuacar@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Semiha Akın, Prof.
    Phone
    +902167779317
    Email
    semihaakin@sbu.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elif Acar, Msc.
    Organizational Affiliation
    University of Health science
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Semiha Akın, Prof.
    Organizational Affiliation
    University of Health science
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    The Effect of Individualized Education Using the Teach-Back Method Treatment on Treatment Adherence and the Coping Skills

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