xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05978479</url>
    </required_header>
    <id_info>
      <org_study_id>SaglikBilimleriUEACAR0001</org_study_id>
      <nct_id>NCT05978479</nct_id>
    </id_info>
    <brief_title>The Effect of Individualized Education Using the Teach-Back Method Treatment on Treatment Adherence and the Coping Skills</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study was planned to evaluate the effect of individual education given to adult patients&#xD;
        with End Stage Renal Disease receiving hemodialysis treatment, using the Roy Adaptation&#xD;
        Model-Based Teach Back Method under the guidance of nurses, on their ability to cope with&#xD;
        fluid, diet and medication compliance and their adaptation skills.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a randomized, controlled, two-group intervention trial with pretest-posttest&#xD;
        design at three centers. The study will enroll adult End Stage Renal Disease patients&#xD;
        receiving hemodialysis treatment who meet the inclusion criteria at the three centers where&#xD;
        the study is being conducted. Data for the study will be collected using face-to-face&#xD;
        interviews, a patient information form, a hemodialysis treatment information form, the&#xD;
        End-Stage Renal Disease Adherence Questionnaire, a Coping and Adaptation Processing Scale,&#xD;
        and a &quot;Teach Back Method&quot; questionnaire. Patients participating in the study will receive an&#xD;
        educational booklet that will be completed after obtaining expert opinion based on the&#xD;
        literature from the researcher. Patients in the intervention group will be trained by the&#xD;
        researcher using the &quot;Teach Back Method&quot; in three sessions. Each session will last 45-60&#xD;
        minutes. From the 2nd week of the study, patients' questions will be answered and a 15-minute&#xD;
        retraining session will be made in every two weeks. Patients in the control group will&#xD;
        undergo a pretest and a posttest, and their routine care and treatment will continue. At the&#xD;
        end of the study, patients in the control group will take training booklets.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">December 8, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 8, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients in the intervention group (experimental group) will receive a hemodialysis training booklet and face-to-face training using the &quot;Teach Back Method&quot; in three sessions held every other day. The routine care and treatment of the control group will be continued.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Effect of education conducted with the &quot;Teach Back Method&quot; on treatment adherence</measure>
      <time_frame>Twelve weeks</time_frame>
      <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 &quot;Teach Back Method&quot; 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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effects of the Teach Back Method education on coping with and adaptation to hemodialysis treatment.</measure>
      <time_frame>Twelve weeks</time_frame>
      <description>This study evaluates the effect of training received by patients in the intervention group using the &quot;Teach Back Method&quot; with Coping and Adaptation Processing Scale to cope with and adaptate to hemodialysis treatment.&#xD;
  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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effectiveness of using the Teach Back Method in hemodialysis patients</measure>
      <time_frame>Ten weeks</time_frame>
      <description>The effectiveness of the training for patients in the intervention group will be evaluated every two weeks using the &quot;Teach Back Method&quot; questionnaire.&#xD;
  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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Effect of the Training given with the Teach Back Method on Interdialytic Weight</measure>
      <time_frame>Twelve weeks</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effect of training given with the Teach-Back Method on the amount of ultrafiltration</measure>
      <time_frame>Twelve weeks</time_frame>
      <description>The effect of the training given with the teach-back method on the amount of ultrafiltration will be examined.&#xD;
  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%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effect of training given with the Teach Back Method on arterial blood pressure</measure>
      <time_frame>Twelve weeks</time_frame>
      <description>The effect of training given with the teach-back method on arterial blood pressure will be examined.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The effect of training given with the Teach Back Method on dialysis adequacy (Kt/V)</measure>
      <time_frame>Twelve weeks</time_frame>
      <description>The effect of individual training given with the teach-back method on dialysis adequacy will be examined.&#xD;
  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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>End Stage Renal Disease on Dialysis</condition>
    <arm_group>
      <arm_group_label>Teach-Back Method</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention will be given to the patients in the control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Teach-Back Method</intervention_name>
      <description>No intervention will be given to the patients in the control group.</description>
      <arm_group_label>Teach-Back Method</arm_group_label>
      <other_name>Control group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hemodialysis treatment for 4 hours, three times a week for at least 3 months with a&#xD;
               diagnosis of end-stage renal failure,&#xD;
  &#xD;
            -  Individuals between the ages of 18 and 65 years,&#xD;
  &#xD;
            -  Having no speech, vision or hearing problems,&#xD;
  &#xD;
            -  Be able to speak, read and write in Turkish,&#xD;
  &#xD;
            -  Patients who have voluntarily to participate and informed consent form in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who do not participate or agree to participate in training,&#xD;
  &#xD;
            -  The general situation is not suitable for questioning,&#xD;
  &#xD;
            -  Those diagnosed with a cognitive disease such as dementia.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elif Acar, Msc.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Health science</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Semiha Akın, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Health science</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elif Acar, Msc.</last_name>
      <phone>+905052623723</phone>
      <email>elifuacar@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Semiha Akın, Prof.</last_name>
      <phone>+902167779317</phone>
      <email>semihaakin@sbu.edu.tr</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 1, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
      <investigator_full_name>ELIF ACAR</investigator_full_name>
      <investigator_title>PhD student internal medicine nursing</investigator_title>
    </responsible_party>
    <keyword>Hemodialysis</keyword>
    <keyword>End-stage renal failure</keyword>
    <keyword>Treatment adherence</keyword>
    <keyword>Fluid and dietary restrictions</keyword>
    <keyword>Teach-Back Method</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Kidney Failure, Chronic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05978479
  org study id: SaglikBilimleriUEACAR0001
  nct id: NCT05978479
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Effect of education conducted with the "Teach Back Method" on treatment adherence
  time frame: Twelve weeks
  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.
  measure: The effects of the Teach Back Method education on coping with and adaptation to hemodialysis treatment.
  time frame: Twelve weeks
  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.
  measure: The effectiveness of using the Teach Back Method in hemodialysis patients
  time frame: Ten weeks
  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.
  measure: The Effect of the Training given with the Teach Back Method on Interdialytic Weight
  time frame: Twelve weeks
  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.
  measure: The effect of training given with the Teach-Back Method on the amount of ultrafiltration
  time frame: Twelve weeks
  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%.
  measure: The effect of training given with the Teach Back Method on arterial blood pressure
  time frame: Twelve weeks
  description: The effect of training given with the teach-back method on arterial blood pressure will be examined.
  measure: The effect of training given with the Teach Back Method on dialysis adequacy (Kt/V)
  time frame: Twelve weeks
  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.
  arm group label: Teach-Back Method
  arm group type: Experimental
  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 group label: Control group
  arm group type: No Intervention
  description: No intervention will be given to the patients in the control group.
  intervention type: Other
  intervention name: Teach-Back Method
  description: No intervention will be given to the patients in the control group.
  arm group label: Teach-Back Method
  other name: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Elif Acar, Msc.
  role: Principal Investigator
  affiliation: University of Health science
  last name: Semiha Akın, Prof.
  role: Principal Investigator
  affiliation: University of Health science
  last name: Elif Acar, Msc.
  phone: +905052623723
  email: elifuacar@gmail.com
  last name: Semiha Akın, Prof.
  phone: +902167779317
  email: semihaakin@sbu.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi
  investigator full name: ELIF ACAR
  investigator title: PhD student internal medicine nursing
  mesh term: Kidney Diseases
  mesh term: Kidney Failure, Chronic