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NCT Number: NCT07747012

Nurse-Led Dialysis Self-Management Program for Hemodialysis Distress

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.

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Key information

Conditions

Hemodialysis Behavior Dialysis-Related Distress Health Behavior Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Simav Doc. Dr. Ismail Karakuyu State Hospital

Simav, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-Led Needs-Based Dialysis Self-Management Program

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer

    Time frame: 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.

Secondary outcomes

  1. Illness and Treatment Uncertainty Assessed by the Uncertainty in Chronic Dialysis Treatment Scale

    Time frame: Baseline, 6 weeks, and 18 weeks

    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.

  2. Treatment Adherence Assessed by the End-Stage Renal Disease Adherence Questionnaire

    Time frame: Baseline, 6 weeks, and 18 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Serkan Budak, PhD / RN

CONTACT

[email protected]

+905385430616

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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