NCT05978479

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

May 1, 2023

Last Update Submit

July 29, 2023

Conditions

Keywords

HemodialysisEnd-stage renal failureTreatment adherenceFluid and dietary restrictionsTeach-Back Method

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • The Effect of the Training given with the Teach Back Method on Interdialytic Weight

    Twelve weeks

  • The effect of training given with the Teach-Back Method on the amount of ultrafiltration

    Twelve weeks

  • The effect of training given with the Teach Back Method on arterial blood pressure

    Twelve weeks

  • The effect of training given with the Teach Back Method on dialysis adequacy (Kt/V)

    Twelve weeks

Study Arms (2)

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.

Other: Teach-Back Method

Control group

NO INTERVENTION

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

Interventions

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

Also known as: Control group
Teach-Back Method

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, ChronicTreatment Adherence and Compliance

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Elif Acar, Msc.

    University of Health science

    PRINCIPAL INVESTIGATOR
  • Semiha Akın, Prof.

    University of Health science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Acar, Msc.

CONTACT

Semiha Akın, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student internal medicine nursing

Study Record Dates

First Submitted

May 1, 2023

First Posted

August 7, 2023

Study Start

September 4, 2023

Primary Completion

December 8, 2023

Study Completion

December 8, 2023

Last Updated

August 7, 2023

Record last verified: 2023-07