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| ID | Type | Description | Link |
|---|---|---|---|
| Self Funding | Other Identifier | NTUNHS |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Theory-based fluid self-management program | Experimental | 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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| Control Group For A Theory-based fluid self-management program | No Intervention | Using standar routine for health education |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A Theory-based fluid self-management program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Each participant's hemodialysis sessions over an eight-month period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cornelia Dede Yoshima Nekada, PhD Candidate | Contact | +628121444251 | lia.nekada@gmail.com | |
| Tsae-Jyy (Tiffany) Wang, PhD | Contact | +886228227101 | 2300 | tsaejyy@ntunhs.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Soeradji Tirtonegoro General Hospital l. Dr. Soeradji Tirtonegoro No.1, Dusun 1, Tegalyoso | Klaten | Central Java | 57424 | Indonesia |
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| Label | URL |
|---|---|
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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
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Group education sessions led by the principal investigator; individual education sessions led by the principal investigator and nurses trained in hemodialysis nursing education; and behavioral intervention strategies based on the Individual and Family Self-Management Theory. Follow-up social support sessions via a WhatsApp channel were conducted by the principal investigator and a designated research team. To maintain the principle of blinding, the selected research team will help monitor the number of participants who respond with emojis and submit their digital diaries. If entries are incomplete, the research team will contact the participants to have them completed. The designated research team has undergone training in accordance with the principles of this intervention study. The training covered standardization of the intervention protocol, motivational communication, IFSMT principles, and patient counseling skills.
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| 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. | At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9 |
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