RecruitingNot ApplicableNCT07747012

Nurse-Led Dialysis Self-Management Program for Hemodialysis Distress

The Effect of a Nurse-Led Needs-Based Dialysis Self-Management Program on Dialysis-Related Distress in Hemodialysis Patients: A Randomized Controlled Trial

Sponsor

Kutahya Health Sciences University

Enrollment

100 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

Hemodialysis Dialysis-Related Distress

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Nurse-Led Needs-Based Dialysis Self-Management Program and a behavioral approach called Routine Hemodialysis Care for people with dialysis-related distress and hemodialysis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNurse-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.

BEHAVIORALRoutine 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.