A Theory-based Fluid Self-management Program
24. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
160
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Cornelia Dede Yoshima Nekada, PhD Candidate
- Telefonnummer: +628121444251
- E-post: lia.nekada@gmail.com
Studer Kontakt Backup
- Navn: Tsae-Jyy (Tiffany) Wang, PhD
- Telefonnummer: 2300 +886228227101
- E-post: tsaejyy@ntunhs.edu.tw
Studiesteder
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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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Ta kontakt med:
- Agus Suharto, S.Kep.Ners.MARS, Master
- Telefonnummer: +6283867764860
- E-post: agussuhartomistik@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Ingen inngripen: Control Group For A Theory-based fluid self-management program
Using standar routine for health education
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Interdialytic Weight Gain
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fluid Adherence in Hemodialysis Patients
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
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Hjelpsomme linker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
31. desember 2026
Studiet fullført (Antatt)
28. februar 2027
Datoer for studieregistrering
Først innsendt
17. juni 2026
Først innsendt som oppfylte QC-kriteriene
24. juni 2026
Først lagt ut (Faktiske)
1. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- NTUNHS22052026
- Self Funding (Annen identifikator: NTUNHS)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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