A Theory-based Fluid Self-management Program
ConditionHemodialysis Patient
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taipei University of Nursing and Health Sciences
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
A Theory-based fluid self-management program
BehavioralThe 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: A Theory-based fluid self-management programExperimental treatment 1 intervention
Group B: Control Group For A Theory-based fluid self-management programNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 period2
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 periodSecondary outcomes
1
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 92
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 9Sponsors and contacts
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Source ClinicalTrials.gov
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