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Effect of the Smart Hemodialysis Self-Management Innovation on Selected Outcomes for Preventing Volume Overload in Patients Initiating Hemodialysis During the First Three Months

Effect of the Smart Hemodialysis Self-Management Innovation on Selected Outcomes for Preventing Volume Overload in Patients Initiating Hemodialysis During the First Three Months

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251229015
Enrollment
50
Registered
2025-12-29
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease (ESRD) patients undergoing hemodialysis, particularly during the first three months of treatment. End-Stage Renal Disease

Interventions

The Smart Hemodialysis Self-Management Program integrates self-management principles with Design Thinking and digital technology to support patients starting hemodialysis. The intervention includes an
Experimental Behavioral
Smart Hemodialysis Self-Management Program

Sponsors

Personal funding of the investigator
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1 Patients diagnosed with End Stage Renal Disease ESRD who started hemodialysis within the first 3 months and are aged 18 years or older. 2 Patients receiving hemodialysis 2 times per week. 3 Patients or caregivers able to read and understand Thai language. 4 Patients or caregivers who have a smartphone capable of using LINE application. 5 Patients or caregivers aged over 60 years will be assessed with MMSE Thai 2002 by trained researchers. Passing scores are greater than 14 for illiterate persons, greater than 17 for primary education or lower, and greater than 22 for higher education. Those with scores below standard or mild cognitive impairment will be excluded. 6 Patients who voluntarily provide informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1 Patients with severe or critical illness during the study period that may affect outcome evaluation such as sepsis or acute heart failure. 2 Patients who plan to undergo kidney transplantation within the study period.

Design outcomes

Primary

MeasureTime frame
Interdialytic Weight Gain (IDWG) Week 8 Mean interdialytic weight gain (kg) and Measured by pre- and post-dialysis body weight and calculated IDWG

Secondary

MeasureTime frame
Self-management Behavior Score Week 8 Self-management behavior questionnaire for fluid overload prevention and Scoring using a validated assessment tool,Satisfaction With the Innovation End of program, Week 8 Satisfaction questionnaire regarding the use of the innovation (E-book, LINE, Chatbot)

Countries

Thailand

Contacts

Public ContactTatdao Kongrach

Faculty of Medicine, Khon Kaen University

tatdao.k@kkumail.com624537565

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026