Nurse-Led Dialysis Self-Management Program for Hemodialysis Distress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKutahya Health Sciences University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse-Led Needs-Based Dialysis Self-Management Program
BehavioralThe 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
BehavioralParticipants 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Nurse-Led Needs-Based Dialysis Self-Management ProgramExperimental treatment 1 intervention
Group B: Routine Hemodialysis CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer
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.
Time frame
Baseline, 6 weeks, and 18 weeksSecondary outcomes
1
Illness and Treatment Uncertainty Assessed by the Uncertainty in Chronic Dialysis Treatment Scale
Illness and treatment uncertainty will be assessed using the Uncertainty in Chronic Dialysis Treatment Scale. The scale includes 17 items and five subscales. Total raw scores range from 17 to 85 and can be transformed to a 0 to 100 scale. Higher scores indicate higher illness and treatment uncertainty.
Time frame
Baseline, 6 weeks, and 18 weeks2
Treatment Adherence Assessed by the End-Stage Renal Disease Adherence Questionnaire
Treatment adherence will be assessed using the End-Stage Renal Disease Adherence Questionnaire. The scale includes 9 items and four subscales: hemodialysis attendance, medication use, fluid restriction, and diet restriction. Total scores range from 0 to 1200. Higher scores indicate higher adherence to treatment.
Time frame
Baseline, 6 weeks, and 18 weeksSponsors and contacts
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Source ClinicalTrials.gov