NCT07069634

Brief Summary

Background: Depression is one of the most common psychiatric disorders among hemodialysis patients and is associated with increased morbidity and mortality. Due to the chronic nature of the disease and the burdens of treatment, patients often experience psychological distress. The Teach-Back Method is a patient education strategy that ensures comprehension and retention by having patients repeat the information in their own words, and has shown promise in managing chronic conditions. Objective: This study aimed to evaluate the effect of individualized education using the Teach-Back Method on the depression levels of adult patients undergoing hemodialysis. Methods: This was a two-center, randomized controlled interventional study with a pre-test-post-test design. A total of 40 patients with End-Stage Renal Disease (ESRD), aged between 18-65, who had been receiving hemodialysis for at least three months, were randomly assigned to intervention (n=20) and control (n=20) groups. The intervention group received three sessions of individualized education using the Teach-Back Method, while the control group received no intervention during the study. Depression levels were assessed using the Beck Depression Inventory (BDI) before and three months after the intervention. Hypothesis H1: Individual education provided using the Teach-Back Method reduces the level of depression in adult ESRD patients receiving hemodialysis treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 31, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

June 23, 2025

Last Update Submit

July 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Depression scores

    Individual education given to adult ESRD patients receiving hemodialysis using the TeachBack Method reduces depression levels.

    For 12 weeks The intervention group consisted of patients who received hemodialysis treatment on Tuesdays, Thursdays, and Saturdays, and the control group consisted of patients who received treatment on Mondays, Wednesdays, and Fridays.

Study Arms (2)

Control group

NO INTERVENTION

They were asked to respond to the scale questions (post-test) 12 weeks after the pre-test and the first interview at the beginning of the study.

Individual training using the Teach Back Method

EXPERIMENTAL

Pre-test was collected with patients receiving hemodialysis treatment. Individual training was given to the intervention group patients using the Tell What You Learned Method using face-to-face and individual interview techniques. The training was carried out in 3 sessions. After the training sessions were completed, they were asked to answer questions asked by the researcher in order to evaluate their knowledge, skills and behaviors regarding the Tell What You Learned Method. The intervention group patients were given a post-test in the third month (12th week) after the first interview.

Other: Individual training using the Teach Back Method

Interventions

Day 1 (Monday): Patients are introduced to the study; consent forms are signed, and initial forms are completed. An educational booklet is provided and explained. General information about hemodialysis and treatment is delivered using the Teach-Back Method. Day 2 (Wednesday): Patients recall previous session topics; unclear points are clarified. Education focuses on fluid and dietary restrictions and the importance of adherence, using the Teach-Back Method. Day 3 (Friday): Patients summarize previous content; the researcher reinforces unclear areas. Education covers medication adherence and lifestyle habits, again using the Teach-Back Method.

Individual training using the Teach Back Method

Eligibility Criteria

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

You may qualify if:

  • Those who have been diagnosed with end-stage renal failure and have received hemodialysis treatment 3 times a week for 4 hours for at least 3 months, have no communication problems and are between the ages of 18-65

You may not qualify if:

  • Patients who did not attend any of the educational sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Faculty of Nursing

Istanbul, Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research is a two-center, randomized, interventional (educational) type research with intervention and control groups, pre-test-post-test design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 17, 2025

Study Start

March 31, 2025

Primary Completion

June 15, 2025

Study Completion

June 15, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations