NCT07677605

Brief 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 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

June 17, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 17, 2026

Last Update Submit

June 24, 2026

Conditions

Hemodialysis Patient

Keywords

Fluid-Self Management ProgramInterdialytic Weight Gain Control

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Each participant's hemodialysis sessions over an eight-month period

Secondary Outcomes (2)

  • Fluid Adherence in Hemodialysis Patients

    At Baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9

  • Hemodialysis Self-Management Behaviours

    At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9

Study Arms (2)

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.

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

Interventions

A Theory-based fluid self-management programBEHAVIORAL

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.

Also known as: Interdialytic Weight Gain Control in Hemodialysis Patients
A Theory-based fluid self-management program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Soeradji Tirtonegoro General Hospital l. Dr. Soeradji Tirtonegoro No.1, Dusun 1, Tegalyoso

Klaten, Central Java, 57424, Indonesia

Location

Related Links

Central Study Contacts

Cornelia Dede Yoshima Nekada, PhD Candidate

CONTACT

+628121444251lia.nekada@gmail.com

Tsae-Jyy (Tiffany) Wang, PhD

CONTACT

+886228227101tsaejyy@ntunhs.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
International PhD Student in National Tapei University of Nursing and Health Sciencies

Study Record Dates

First Submitted

June 17, 2026

First Posted

July 1, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations

ID(1)