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Recruiting Not applicable

Nurse-Led Dialysis Self-Management Program for Hemodialysis Distress

NCT07747012 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-08-01
Last updated
2026-08-13

Condition(s) studied

HemodialysisDialysis-Related Distress

Investigational drug(s) / intervention(s)

Nurse-Led Needs-Based Dialysis Self-Management ProgramRoutine Hemodialysis Care

Nurse-Led Needs-Based Dialysis Self-Management Program: The intervention is a structured 6-week nurse-led needs-based dialysis self-management program. It will be delivered through weekly face-to-face individual sessions lasting approximately 40 to 45 minutes. The program includes standard core education and needs-based individualized counseling. The content focuses on the hemodialysis process and individual needs assessment, fluid management and interdialytic weight control, diet and potassium/phosphorus management, medication adherence and treatment continuity, symptom and distress management, coping with treatment uncertainty, and development of a sustainable dialysis self-management plan. Intervention fidelity will be monitored using a standardized session checklist.

Routine Hemodialysis Care: Participants will continue to receive routine hemodialysis care. No additional structured education or counseling program will be provided by the research team during the study period.

Study summary

Hemodialysis patients may experience dialysis-related distress due to long-term treatment requirements, dietary and fluid restrictions, medication use, vascular access problems, dialysis-related symptoms, and psychosocial challenges. Nurse-led self-management programs may help patients improve dialysis self-management, reduce distress, and support treatment adherence.

This study aims to evaluate the effect of a nurse-led needs-based dialysis self-management program on dialysis-related distress in patients receiving hemodialysis. The study will be conducted as a single-center, two-arm, parallel-group, randomized controlled trial. A total of 100 adult hemodialysis patients will be randomly assigned to either the intervention group or the control group in a 1:1 ratio.

Participants in the intervention group will receive a 6-week nurse-led needs-based dialysis self-management program in addition to routine hemodialysis care. Participants in the control group will continue routine hemodialysis care. Data will be collected at baseline, 6 weeks, and 18 weeks. The primary outcome is dialysis-related distress. Secondary outcomes include illness and treatment uncertainty, treatment adherence, and clinical adherence indicators.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Aged 18 years or older * Receiving hemodialysis treatment for at least 3 months * Receiving hemodialysis treatment at least twice per week * Able to read and understand Turkish * Conscious and able to communicate * Providing written informed consent Exclusion Criteria: * Advanced cognitive impairment * Active psychiatric crisis * History of major surgery or acute severe illness within the last 3 months * Planned kidney transplantation in the near future * Serious physical or communication problems that may prevent regular participation in the intervention sessions * Concurrent participation in another structured education or psychosocial intervention program

Primary outcome measure(s)

  • Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer — Baseline, 6 weeks, and 18 weeks
    Dialysis-related distress will be assessed using the Hemodialysis Distress Thermometer. The instrument includes a distress barometer scored from 0 to 10, where 0 indicates no distress and 10 indicates extreme distress. Higher scores indicate higher perceived dialysis-related distress. The instrument also includes a 40-item problem checklist scored from 0 to 40, where higher scores indicate a greater number of distress-related problems.

Trial sites (1)

FacilityCityRegionStatus
Simav Doc. Dr. Ismail Karakuyu State Hospital Simav Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07747012 on ClinicalTrials.gov ↗ ← All trials in Turkey