A Theory-based Fluid Self-management Program

June 24, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cornelia Dede Yoshima Nekada, PhD Candidate
  • Phone Number: +628121444251
  • Email: lia.nekada@gmail.com

Study Contact Backup

Study Locations

  • Indonesia
    • Central Java
      • Klaten, Central Java, Indonesia, 57424
        • Dr. Soeradji Tirtonegoro General Hospital l. Dr. Soeradji Tirtonegoro No.1, Dusun 1, Tegalyoso
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: A Theory-based fluid self-management program
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.
Other Names:
  • Interdialytic Weight Gain Control in Hemodialysis Patients
No Intervention: Control Group For A Theory-based fluid self-management program
Using standar routine for health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interdialytic Weight Gain
Time Frame: Each participant's hemodialysis sessions over an eight-month period
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
Time Frame: Each participant's hemodialysis sessions over an eight-month period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluid Adherence in Hemodialysis Patients
Time Frame: At Baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
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.
At Baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
Hemodialysis Self-Management Behaviours
Time Frame: At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9
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.
At baseline before intervention, midle of intervention at week four, and after completing the intervention at week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NTUNHS22052026
  • Self Funding (Other Identifier: NTUNHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemodialysis Patient

Clinical Trials on A Theory-based fluid self-management program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe