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
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Serkan Budak, PhD / RN
- Numer telefonu: +905385430616
- E-mail: serkan.budak@ksbu.edu.tr
Lokalizacje studiów
-
-
-
Simav, Turcja (Türkiye)
- Rekrutacyjny
- Simav Doc. Dr. Ismail Karakuyu State Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Nurse-Led Needs-Based Dialysis Self-Management Program
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.
|
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.
|
|
Aktywny komparator: Routine Hemodialysis Care
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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer
Ramy czasowe: 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.
|
Baseline, 6 weeks, and 18 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Illness and Treatment Uncertainty Assessed by the Uncertainty in Chronic Dialysis Treatment Scale
Ramy czasowe: 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.
|
Baseline, 6 weeks, and 18 weeks
|
|
Treatment Adherence Assessed by the End-Stage Renal Disease Adherence Questionnaire
Ramy czasowe: 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.
|
Baseline, 6 weeks, and 18 weeks
|
Współpracownicy i badacze
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- KSBU-HD-RCT-2026-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .