A Theory-based Fluid Self-management Program
24 juni 2026 bijgewerkt door: Cornelia Dede Yoshima Nekada, National Taipei University of Nursing and Health Sciences
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Ingrijpend
Inschrijving (Geschat)
160
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Cornelia Dede Yoshima Nekada, PhD Candidate
- Telefoonnummer: +628121444251
- E-mail: lia.nekada@gmail.com
Studie Contact Back-up
- Naam: Tsae-Jyy (Tiffany) Wang, PhD
- Telefoonnummer: 2300 +886228227101
- E-mail: tsaejyy@ntunhs.edu.tw
Studie Locaties
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Central Java
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Klaten, Central Java, Indonesië, 57424
- Dr. Soeradji Tirtonegoro General Hospital l. Dr. Soeradji Tirtonegoro No.1, Dusun 1, Tegalyoso
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Contact:
- Agus Suharto, S.Kep.Ners.MARS, Master
- Telefoonnummer: +6283867764860
- E-mail: agussuhartomistik@gmail.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: A Theory-based fluid self-management program
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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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.
Andere namen:
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Geen tussenkomst: Control Group For A Theory-based fluid self-management program
Using standar routine for health education
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Interdialytic Weight Gain
Tijdsspanne: Each participant's hemodialysis sessions over an eight-month period
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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
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Each participant's hemodialysis sessions over an eight-month period
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Mean Arterial Pressure
Tijdsspanne: Each participant's hemodialysis sessions over an eight-month period
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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
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Each participant's hemodialysis sessions over an eight-month period
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Fluid Adherence in Hemodialysis Patients
Tijdsspanne: At Baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
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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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At Baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
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Hemodialysis Self-Management Behaviours
Tijdsspanne: At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
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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.
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At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
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- 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), 2723-2728
- 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),
- 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.
- 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-E58
- Bertrand, M., Goury, A., Chemla, D., Teboul, J.-L., & Hamzaoui, O. (2025). Applied physiology at the bedside: Using invasive blood pressure as a true monitoring tool. Annals of Intensive Care, 15(1), 192
- Bossola, M., Mariani, I., Sacco, M., Antocicco, M., Pepe, G., & Di Stasio, E. (2024). Interdialytic weight gain and low dialysate sodium concentration in patients on chronic hemodialysis: A systematic review and meta-analysis. International Urology and N
- Driehuis, E., Meuleman, Y., Bonenkamp, A. A., Dekker, F. W., Abrahams, A. C., & Van Jaarsveld, B. C. (2024). Self-Management Barriers in Patients on Dialysis: A Potential Target for Improving Clinical and Patient-Reported Outcomes: TH-PO301. Journal of t
- Freidenson-Bejar, J., Espinoza, D., Calderon-Flores, R., Mejia, F., & González-Lagos, E. (2025). Intervention With WhatsApp Messaging to Compare the Effect of Self-Designed Messages and Standardized Messages in Adherence to Antiretroviral Treatment in Yo
- Friedrich, N. K., Schmitt, N., Hruby, H., & Kugler, C. (2025). Self-management interventions for adult haemodialysis patients: A scoping review of randomized controlled trials. BMC Nephrology, 26(1), 285
- Jalil, H., Chong, M.-C., Jalaludin, M. Y., & Wong, L. P. (2025). Impact of breastfeeding education with WhatsApp follow-up on infant feeding, growth, and health outcomes: A quasi-experimental study in Malaysia. Archives of Public Health, 83(1), 311
- Kumar, S., Yadav, S., & Kumar, A. (2024). Blood pressure measurement techniques, standards, technologies, and the latest futuristic wearable cuff-less know-how. Sensors & Diagnostics, 3(2), 181-202
- Li, W.-Y., Yeh, J.-C., Cheng, C.-C., Huang, S.-H., Yeh, H.-C., Cheng, B.-W., Lin, J.-W., & Yang, F.-J. (2024). Digital health interventions to promote healthy lifestyle in hemodialysis patients: An interventional pilot study. Scientific Reports, 14(1), 2
- Lightfoot, C. J., Wilkinson, T. J., Sohansoha, G. K., Gillies, C. L., Vadaszy, N., Ford, E. C., Davies, M. J., Yates, T., Smith, A. C., Graham-Brown, M. P. M., On behalf of SMILE-K collaborators, McCafferty, K., Phillips, T., Winter-Goodwin, B., Sridhara
- Liu, Y., Luo, X., Ru, X., Wen, C., Ding, N., & Zhang, J. (2024). Impact of a multimodal health education combined with teach-back method on self-management in hemodialysis patients: A randomized controlled trial. Medicine, 103(52), e39971
- Moreels, T., Van De Velde, D., Goethals, J., Vanden Wyngaert, K., De Baets, S., Nagler, E., Leune, T., De Vriendt, P., & Van Biesen, W. (2024). Self-Management Interventions for Facilitating Life Participation for Persons with Kidney Failure: A Systemati
- Park, Y., & Jung, S. (2025). Predictors of self-management behaviors among patients undergoing hemodialysis. Scientific Reports, 15(1), 13823
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- Wang, L., Gao, H., Liu, X., Wang, H., Yuan, J., Chen, M., Zheng, Y., & Ma, S. (2025). Self-Management and Its Predictors in Maintenance Hemodialysis Patients: Based on Triadic Reciprocal Determinism. International Journal of Nephrology and Renovascular D
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juli 2026
Primaire voltooiing (Geschat)
31 december 2026
Studie voltooiing (Geschat)
28 februari 2027
Studieregistratiedata
Eerst ingediend
17 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
24 juni 2026
Eerst geplaatst (Werkelijk)
1 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
24 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- NTUNHS22052026
- Self Funding (Andere identificatie: NTUNHS)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .