An interventional study of A Theory-based fluid self-management program in Hemodialysis Patient, sponsored by National Taipei University of Nursing and Health Sciences. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by National Taipei University of Nursing and Health Sciences · Not applicable, Interventional, and Prevention
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.
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
National Taipei University of Nursing and Health Sciences is the lead sponsor of 124 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: A Theory-based fluid self-management program
Using standar routine for health education
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.
Also known as: Interdialytic Weight Gain Control in Hemodialysis Patients
Interdialytic Weight Gain
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
Time frame: Each participant's hemodialysis sessions over an eight-month period
Mean Arterial Pressure
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
Time frame: Each participant's hemodialysis sessions over an eight-month period
Fluid Adherence in Hemodialysis Patients
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.
Time frame: At Baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
Hemodialysis Self-Management Behaviours
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.
Time frame: At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
Plan to share: No — 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
Start is estimated for Jul 2026; primary completion for Dec 2026, 5 months later.
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