A Theory-based Fluid Self-management Program
24 июня 2026 г. обновлено: Cornelia Dede Yoshima Nekada, National Taipei University of Nursing and Health Sciences
Effects of Self-Management Program on Interdialytic Weight Gain Control in Hemodialysis Patients: A Randomized Controlled Trial
This study aims to evaluate the efficacy of an intervention guided by the IFSMT, in which structured education and digitally delivered reinforcement strategies are designed to enhance self-management processes, including knowledge and beliefs, self-regulation skills, and social facilitation, among patients undergoing maintenance hemodialysis.
The intervention, delivered via a mobile platform three times daily over two months, seeks to improve fluid control adherence and hemodialysis self-management behaviours, and to reduce interdialytic weight gain and stabilise pre-hemodialysis mean arterial pressure, compared with standard education alone.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Подробное описание
The intervention implementation process includes: (1) PowerPoint presentations for group and individual education sessions; (2) a social support system using a WhatsApp Channel as a follow-up platform; (3) individual management and monitoring through a diary tracking fluid intake and symptoms of illness; (4) distribution of visual educational materials using digital stickers and posters on the WhatsApp Channel.
Educational materials include: (1) Self-Management of Hemodialysis Treatment; (2) Fluid Intake Control; (3) Self-Management of Nutritional Needs; (4) Self-Management in Seeking Information Sources; (5) Emotional State Management.
The intervention was conducted at Dr. Soeradji Tirtionegoro General Hospital in Klaten and Panembahan Senopati Regional General Hospital in Bantul.
The intervention was implemented through: (1) in-person classes; (2) individual bedside education during hemodialysis sessions; (3) a WhatsApp Channel as a platform for providing social support related to the educational materials provided.
The delivery of this education prioritized patient-centered communication and active patient participation.
Group education sessions lasted 60 minutes and were held once after the initial data collection, while individual education sessions lasted 10 minutes and were held once a week according to the patients' hemodialysis schedules for 8 weeks.
Monitoring and social support were provided three times a day at 9:00, 14:00, and 19:00 WIB for 8 weeks.
The digital logbook was updated once a day for 8 weeks.
This intervention is individually tailored to each patient's learning needs, literacy level, self-management barriers, eating habits, psychosocial conditions, and clinical issues identified during dialysis sessions.
Any changes that occur during the study-including adjustments to the educational focus based on the patient's level of understanding, dialysis complications, or scheduling constraints-will be documented by the research team.
Adherence to the intervention was ensured through: (1) standardized intervention guidelines; (2) training for the research team's nurses; (3) the use of a structured follow-up checklist; (4) routine monitoring meetings led by the principal investigator; and (6) periodic observations of the intervention's implementation.
The principal investigator evaluated adherence to the intervention weekly to ensure consistency among the educators.
The number of educational sessions completed, session duration, participant attendance, and completion of follow-up visits will be documented throughout the study.
Any deviations from the intervention protocol will be recorded and analyzed
Тип исследования
Интервенционный
Регистрация (Оцененный)
160
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Cornelia Dede Yoshima Nekada, PhD Candidate
- Номер телефона: +628121444251
- Электронная почта: lia.nekada@gmail.com
Учебное резервное копирование контактов
- Имя: Tsae-Jyy (Tiffany) Wang, PhD
- Номер телефона: 2300 +886228227101
- Электронная почта: tsaejyy@ntunhs.edu.tw
Места учебы
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Central Java
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Klaten, Central Java, Индонезия, 57424
- Dr. Soeradji Tirtonegoro General Hospital l. Dr. Soeradji Tirtonegoro No.1, Dusun 1, Tegalyoso
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Контакт:
- Agus Suharto, S.Kep.Ners.MARS, Master
- Номер телефона: +6283867764860
- Электронная почта: agussuhartomistik@gmail.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Receiving maintenance hemodialysis for ≥ 3 months
- Undergoing hemodialysis two times per week on a regular schedule
- Possession of a smartphone with active WhatsApp use
- Ability to read and understand Indonesian, with support provided in Javanese where necessary.
- Provision of written informed consent
Exclusion Criteria:
- Severe cognitive impairment or diagnosed psychiatric disorders affecting comprehension or participation, as documented in the medical record.
- Severe visual, hearing, or communication impairments not corrected by assistive devices
- Current hospitalisation or unstable medical condition
- Planned kidney transplantation or dialysis modality change during the study period
- Participation in another interventional study related to fluid management or self-management
- Inability to engage with the WhatsApp Channel follow-up
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Одногрупповое задание
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: A Theory-based fluid self-management program
The intervention implementation process includes: (1) PowerPoint presentations for group and individual education sessions; (2) a social support system using a WhatsApp Channel as a follow-up platform; (3) individual management and monitoring through a diary tracking fluid intake and symptoms of illness; (4) distribution of visual educational materials using digital stickers and posters on the WhatsApp Channel.
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The intervention intervention process includes: (1) PowerPoint presentations for group and individual education sessions; (2) a social support system using a WhatsApp Channel as a follow-up platform; (3) individual management and monitoring through a diary tracking fluid intake and symptoms of illness; (4) distribution of visual educational materials using digital stickers and posters on the WhatsApp Channel.
Другие имена:
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Без вмешательства: Control Group For A Theory-based fluid self-management program
Using standar routine for health education
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Interdialytic Weight Gain
Временное ограничение: Each participant's hemodialysis sessions over an eight-month period
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The percentage increase (%) in body weight between two hemodialysis sessions, calculated as the difference between the current pre-hemodialysis body weight and the post-hemodialysis body weight from the previous session, divided by the prescribed dry weight set by the nephrologist.
Using percentage (%) as a unit, with rasio scale (continuos variable), and data source by medical record
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Each participant's hemodialysis sessions over an eight-month period
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Mean Arterial Pressure
Временное ограничение: Each participant's hemodialysis sessions over an eight-month period
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The mean arterial pressure, which reflects organ perfusion, is calculated based on systolic and diastolic blood pressure measurements taken with a calibrated sphygmomanometer before and after the hemodialysis session.
Using percentage (mmHg) as a unit, with rasio scale (continuos variable), and data source by medical record
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Each participant's hemodialysis sessions over an eight-month period
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Fluid Adherence in Hemodialysis Patients
Временное ограничение: At Baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
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The patient completes a self-reported FCHPS (Fluid Control in Hemodialysis Patients Scale) questionnaire, which consists of 24 items across 3 subscales: knowledge, behaviour, and attitude.
Each item is rated on a 3-point Likert scale: 3 (agree); 2 (indecisive); 1 (disagree).
Interval Scales with a total range of 24-72, and the mean of the fluid control scale at every time observation per person.
Higher scores indicate better fluid adherence.
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At Baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
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Hemodialysis Self-Management Behaviours
Временное ограничение: At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
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Patient completes a self-reported HDSMI-18 (Hemodialysis Self-Management Instrument-18) questionnaire covering 4 subscales: partnership, self-care, problem solving, and emotional management.
Each item is rated on a 4-point Likert scale: 1 = never, 2 = rarely, 3 = sometimes, 4 = always.
Interval Scales with a total range of 18-72, and the mean of self-management scores at every time observation per person.
Higher scores indicate better self-management behaviour.
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At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Полезные ссылки
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 июля 2026 г.
Первичное завершение (Оцененный)
31 декабря 2026 г.
Завершение исследования (Оцененный)
28 февраля 2027 г.
Даты регистрации исследования
Первый отправленный
17 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
24 июня 2026 г.
Первый опубликованный (Действительный)
1 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
1 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
24 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- NTUNHS22052026
- Self Funding (Другой идентификатор: NTUNHS)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Individual participant data (IPD) will not be publicly available due to ethical and confidentiality restrictions imposed by the participating instituitions and the informed consent agreement signed by participants
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .