A Theory-based Fluid Self-management Program
keskiviikko 24. kesäkuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
160
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Cornelia Dede Yoshima Nekada, PhD Candidate
- Puhelinnumero: +628121444251
- Sähköposti: lia.nekada@gmail.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Tsae-Jyy (Tiffany) Wang, PhD
- Puhelinnumero: 2300 +886228227101
- Sähköposti: tsaejyy@ntunhs.edu.tw
Opiskelupaikat
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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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Ottaa yhteyttä:
- Agus Suharto, S.Kep.Ners.MARS, Master
- Puhelinnumero: +6283867764860
- Sähköposti: agussuhartomistik@gmail.com
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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.
Muut nimet:
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Ei väliintuloa: Control Group For A Theory-based fluid self-management program
Using standar routine for health education
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Interdialytic Weight Gain
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Fluid Adherence in Hemodialysis Patients
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
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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
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- Self Funding (Muu tunniste: NTUNHS)
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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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