An interventional study of Nurse-Led Needs-Based Dialysis Self-Management Program and Routine Hemodialysis Care in Hemodialysis and Dialysis-Related Distress, sponsored by Kutahya Health Sciences University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Supportive care
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.
The intervention is a structured, non-invasive, education- and counseling-based behavioral nursing intervention. The nurse-led needs-based dialysis self-management program aims to improve self-management skills, reduce dialysis-related distress, decrease illness and treatment uncertainty, and support treatment adherence.
The program will be delivered over 6 weeks through weekly face-to-face individual sessions lasting approximately 40 to 45 minutes. The intervention includes two components: standard core education and needs-based individualized counseling. Standard core education will be delivered to all participants in the intervention group. Individualized counseling will be guided by participants' baseline dialysis-related distress, illness and treatment uncertainty, treatment adherence, and clinical indicators.
The intervention content includes 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 self-management plan. Intervention fidelity will be monitored using a standardized session checklist.
114 studies on the registry are indexed under Treatment Adherence and Compliance; 60 are open to participants now.
This study's planned enrollment of 100 is above the median of 84 across 97 interventional studies indexed under Treatment Adherence and Compliance.
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Exclusion Criteria:
Participants in this arm will receive a 6-week nurse-led needs-based dialysis self-management program in addition to routine hemodialysis care. The program includes weekly face-to-face individual sessions lasting approximately 40 to 45 minutes. The intervention includes standard core education and needs-based individualized counseling focused on fluid management, diet, medication adherence, symptom and distress management, treatment uncertainty, and sustainable dialysis self-management.
Behavioral: Nurse-Led Needs-Based Dialysis Self-Management Program
Participants in this arm 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.
Behavioral: Routine Hemodialysis Care
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.
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.
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 weeks
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 weeks
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 weeks
Plan to share: No — Individual participant data will not be shared because the study includes sensitive health-related information from patients receiving hemodialysis. De-identified aggregate results may be reported in scientific publications.
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