A Theory-based Fluid Self-management Program (NCT07677605) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Theory-based Fluid Self-management Program
Indonesia160 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Interdialytic Weight Gain
Timeframe: Each participant's hemodialysis sessions over an eight-month period
2
Mean Arterial Pressure
Timeframe: Each participant's hemodialysis sessions over an eight-month period
Trial details
NCT IDNCT07677605
SponsorNational Taipei University of Nursing and Health Sciences