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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Other: Teach-Back Method

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Semiha Akın, Prof.; Phone Number: +902167779317; Email: semihaakin@sbu.edu.tr
• Study Contact Backup: Name: Elif Acar, Msc.; Phone Number: +905052623723; Email: elifuacar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention will be given to the patients in the control group.
Experimental: Teach-Back Method; 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.	Other: Teach-Back Method; No intervention will be given to the patients in the control group.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Ten weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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%.	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.	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.	Twelve weeks

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Semiha Akın, Prof., University of Health Science; Principal Investigator: Elif Acar, Msc., University of Health Science

Study record dates

Study Major Dates

• Study Start (Estimated): September 4, 2023
• Primary Completion (Estimated): December 8, 2023
• Study Completion (Estimated): December 8, 2023

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: July 29, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 29, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hemodialysis; Treatment adherence; End-stage renal failure; Fluid and dietary restrictions; Teach-Back Method
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: SaglikBilimleriUEACAR0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No