Nurse-Led Dialysis Self-Management Program for Hemodialysis Distress

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 treatmen
• Поведенческое 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.

Первичные конечные точки

• Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer [Срок оценки: Baseline, 6 weeks, and 18 weeks]

Вторичные конечные точки (2)

• Illness and Treatment Uncertainty Assessed by the Uncertainty in Chronic Dialysis Treatment Scale [Срок оценки: Baseline, 6 weeks, and 18 weeks]
• Treatment Adherence Assessed by the End-Stage Renal Disease Adherence Questionnaire [Срок оценки: Baseline, 6 weeks, and 18 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Simav Doc. Dr. Ismail Karakuyu State Hospital — Simav

Публикации

• Liu L, Liu YP, Wang J, An LW, Jiao JM. Use of a knowledge-attitude-behaviour education programme for Chinese adults undergoing maintenance haemodialysis: Randomized controlled trial. J Int Med Res. 2016 Jun;44(3):557-68. doi: 10.1177/0300060515604980. Epub 2016 Mar 7. PMID 26951842
• Liu Y, Luo X, Ru X, Wen C, Ding N, Zhang J. Impact of a multimodal health education combined with teach-back method on self-management in hemodialysis patients: A randomized controlled trial. Medicine (Baltimore). 2024 Dec 27;103(52):e39971. doi: 10.1097/MD.0000000000039971. PMID 39969380
• Sousa H, Ribeiro O, Figueiredo D. Development process, clinical utility, and preliminary psychometric evidence of a new tool for screening psychological distress in renal care settings: the Hemodialysis Distress Thermometer (HD-DT). Psychol Health. 2025 Oct;40(10):1658-1684. doi: 10.1080/08870446.2024.2347662. Epub 2024 Apr 28. PMID 38679920

Идентификаторы

NCT: NCT07747012 · KSBU-HD-RCT-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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