Hemodialysis PatientNCT07677605
A Theory-based Fluid Self-management Program
A study testing A Theory-based fluid self-management program in people with Hemodialysis Patient, run by National Taipei University of Nursing and Health Sciences at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patient
- What is being tested?
- A Theory-based fluid self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Dr. Soeradji Tirtonegoro General Hospital l. Dr. Soeradji Tirtonegoro No.1, Dusun 1, Tegalyoso
Klaten, Central Java, 57424
Agus Suharto, S.Kep.Ners.MARS, Master, +6283867764860, agussuhartomistik@gmail.com
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Hemodialysis Patient
- Being tested
- A Theory-based fluid self-management program
- Keywords
- Fluid-Self Management Program, Interdialytic Weight Gain Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Theory-based fluid self-management programBehavioural
Also called Interdialytic Weight Gain Control in Hemodialysis Patients
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: A Theory-based fluid self-management program |
| Control Group For A Theory-based fluid self-management program | No intervention | Using standar routine for health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Each participant's hemodialysis sessions over an eight-month period
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelia Dede Yoshima Nekada, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677605
- Sponsor's protocol ID
- NTUNHS22052026
- Other IDs
- Self Funding
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-Management Program on Interdialytic Weight Gain Control in Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07677605
- Acronym / sponsor ID
- NTUNHS22052026
- Conditions
- Hemodialysis Patient
- Keywords
- Fluid-Self Management Program, Interdialytic Weight Gain Control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| A Theory-based fluid self-management program | Experimental | Behavioral: A Theory-based fluid self-management programThe 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. |
| Control Group For A Theory-based fluid self-management program | No intervention | –Using standar routine for health education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Theory-based fluid self-management programAlso: Interdialytic Weight Gain Control in Hemodialysis PatientsThe 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. | Behavioural | A Theory-based fluid self-management program |
Primary outcome
Interdialytic Weight Gain
Time frame: Each participant's hemodialysis sessions over an eight-month period
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
Mean Arterial Pressure
Time frame: Each participant's hemodialysis sessions over an eight-month period
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
2 secondary outcomes
Fluid Adherence in Hemodialysis Patients
Time frame: At Baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
Hemodialysis Self-Management Behaviours
Time frame: At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Abdollahi, M., Fakhar, M., Tajfard, M., Jamali, J., \& Mahdizadeh, M. (2024). Educational WhatsApp-delivered intervention based on social cognitive theory to promote leishmaniosis preventive behavior of health ambassadors: A randomized controlled trial. BLink provided by the sponsor.
- AlaaEldein Elsuity, M., Butt, F. A., Saeed Khan, K., Fawzy, M., Martín-Díaz, M., Chien, P. F. W., Perez De Rojas, J., Núñez-Núñez, M., Rashwan, M. M., \& Bueno-Cavanillas, A. (2025). Ethics and Consent in Randomized Clinical Trial Integrity: A Scoping SysLink provided by the sponsor.
- Alilu, L., Pazirofteh, S., Habibzadeh, H., \& Rasouli, J. (2024). The impact of teach-back training method (TBTM) on treatment adherence in hemodialysis patients: A randomized controlled trial. Annals of Medicine \& Surgery, 86(5), 2723-2728Link provided by the sponsor.
- Allory, E., Scheer, J., De Andrade, V., Garlantézec, R., \& Gagnayre, R. (2024). Characteristics of self-management education and support programmes for people with chronic diseases delivered by primary care teams: A rapid review. BMC Primary Care, 25(1),Link provided by the sponsor.
- Bahmani, M., Bijani, M., Fereidouni, Z., Dehghan, A., \& Modreki, A. (2025). Investigating the impact of interdisciplinary training programs on self-efficacy and life satisfaction among Hemodialysis patients: A randomized controlled clinical trial.Link provided by the sponsor.
- Bauer, W. S., Schiffman, R. F., Ellis, J. L., Erickson, J. M., Polfuss, M., Taani, M. H., \& Sawin, K. J. (2025). An Integrative Review of the Use of the Individual and Family Self-Management Theory in Research. Advances in Nursing Science, 48(2), E41-E58Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Theory-based fluid self-management program in people with Hemodialysis Patient, run by National Taipei University of Nursing and Health Sciences at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cornelia Dede Yoshima Nekada, PhD Candidate (+628121444251, lia.nekada@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interdialytic Weight Gain (time frame: Each participant's hemodialysis sessions over an eight-month period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.