A Theory-based Fluid Self-management Program
24 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Intervencionista
Inscripción (Estimado)
160
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Cornelia Dede Yoshima Nekada, PhD Candidate
- Número de teléfono: +628121444251
- Correo electrónico: lia.nekada@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Tsae-Jyy (Tiffany) Wang, PhD
- Número de teléfono: 2300 +886228227101
- Correo electrónico: tsaejyy@ntunhs.edu.tw
Ubicaciones de estudio
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Central Java
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Klaten, Central Java, Indonesia, 57424
- Dr. Soeradji Tirtonegoro General Hospital l. Dr. Soeradji Tirtonegoro No.1, Dusun 1, Tegalyoso
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Contacto:
- Agus Suharto, S.Kep.Ners.MARS, Master
- Número de teléfono: +6283867764860
- Correo electrónico: agussuhartomistik@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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Sin intervención: Control Group For A Theory-based fluid self-management program
Using standar routine for health education
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Interdialytic Weight Gain
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fluid Adherence in Hemodialysis Patients
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
- 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. B
- 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 Sys
- 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
- Riguen, M., Fendri, B., Kmicha, E. B., Abid, H., Dammak, N., Agrebi, I., Chaker, H., Yaich, S., Kammoun, K., Toumi, S., & Hmida, M. B. (2024). BLOOD PRESSURE CONTROL IN HEMODIALYSIS PATIENTS: CONTRIBUTION OF BIO -IMPEDANCEMETRY. Journal of Hypertension,
- Ryan, P., & Sawin, K. J. (2009). The Individual and Family Self-Management Theory: Background and perspectives on context, process, and outcomes. Nursing Outlook, 57(4), 217-225.e6.
- Sajjadi, S. L., Ghafourifard, M., & Khosroshahi, H. T. (2024). The effect of individualized education on learning needs of patients undergoing hemodialysis: A randomized controlled clinical trial. BMC Nephrology, 25(1), 452.
- Sajjadi, S. L., Ghafourifard, M., & Tayebi Khosroshahi, H. (2024). A Randomized Controlled Clinical Trial of Individualized Patient Education on Hemodialysis Adequacy and Interdialytic Weight Gain
- Teuwafeu, D. G., Fonyuy, V. F., Bandolo, N. V., Mahamat, M., Nkoke, C., Fouda Menye, H., & Halle, M.-P. (2025). Prevalence and determinants of thirst distress amongst patients on maintenance haemodialysis. BMC Nephrology, 26(1), 441
- Torabikhah, M., Farsi, Z., & Sajadi, S. A. (2023). Comparing the effects of mHealth app use and face-to-face training on the clinical and laboratory parameters of dietary and fluid intake adherence in hemodialysis patients: A randomized clinical trial. B
- 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
- Wang, X., Yan, B., Zhang, S., Zhou, Y., Zhang, Q., & Li, X. (2025). Management of volume load for patients undergoing hemodialysis via WeChat and home monitoring in China: A protocol for a cluster-randomized trial. BMC Nephrology, 26(1), 58.
- Xia, F., & Wang, G. (2024). Influence of teach-back strategy on hemodialysis related knowledge level, self-efficacy and self-management in patients receiving maintenance hemodialysis. Scientific Reports, 14(1), 4010
- Yan, Y. Y., Chan, L. M. L., Wang, M. P., Kwok, J. Y. Y., Anderson, C. S., & Lee, J. J. (2024). Technology-supported behavior change interventions for reducing sodium intake in adults: A systematic review and meta-analysis. Npj Digital Medicine, 7(1), 72.
- Yasin, F., Khraim, F., Santos, M., Forgrave, D., & Hamad, A. (2024). Factors influencing self-care management in adult hemodialysis patients: An integrative review. Qatar Medical Journal, 2024(1).
- Zhou, X.-H., Chen, H., Yang, W., Wang, L., Chen, L., Zhu, Y., Zhang, Y., Shi, M., & Zhang, Q. (2025). Efficacy of eHealth Interventions for Hemodialysis Patients: Systematic Review and Meta-Analysis. Journal of Medical Internet Research, 27, e67246.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
28 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
17 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de junio de 2026
Publicado por primera vez (Actual)
1 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- NTUNHS22052026
- Self Funding (Otro identificador: NTUNHS)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .