The Self-management Program on Hemodialysis Patients in Cambodia

NCT06871553 | Completed DMC

• 1 other identifier: 076
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease (CKD) is a growing global health issue, with increasing numbers of patients requiring kidney replacement therapy (KRT), particularly in low- and middle-income countries. In Cambodia, the prevalence of CKD is rising, and the demand for hemodialysis treatment is straining healthcare resources. This study aims to develop and evaluate the efficacy of a self-management program focused on improving the knowledge and self-management behaviors of hemodialysis patients in Cambodia. This study will use a quasi-experimental pre- and post-design to improve in patients' knowledge and self-management behavior for CKD patients maintaining on hemodialysis at Siem Reap Provincial Referral Hospital, Cambodia from April 2025 to August 2025. The study population consists of patients undergoing hemodialysis in this hospital who meet the following criteria. The sample size was calculated by using the G Power analysis, on the basis effect size of 0.5, an estimated power of 0.8, and of 0.05. A two tailed test was used to calculate that the sample should be 34 patients. However, because of this pilot nature, we include all patients who meet the inclusion criteria (n= 54). The intervention is designed to provide the self-management program to all participant by the trained nurses. Primary outcome: Patients' self-management behavior, as measured by the researcher-developed questionnaire. Secondary outcome include patient' knowledge score, quality of life, self-monitoring (symptoms, blood pressure, weight, diet, fluid intake, exercise, medication), physical and laboratory data (blood pressure, weight, creatinine, urea) and qualitative data (free comments related to their experience and changes of the participation).

Conditions

Chronic Kidney Disease on Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Patients' self-management behavior

  Patients' self-management behavior, as measured by the researcher-developed questionnaire. The questionnaire has 20 items with the 4 Likert scale (3: applies to me very much, 2: applies to me to a considerable degree, 1: applies to me to some degree, 0: does not apply to me). Score rang is from 0 to 60.

  3 months after baseline data collection

Secondary Outcomes (8)

• Patient' knowledge

  3 months after baseline data collection

• Quality of Life Measurement Using the EQ-5D-5L: A Five-Dimensional Assessment of Health Status

  3 months after baseline data collection

• Self-monitoring

  3 months after baseline data collection

• Blood pressure data

  3 months after baseline data collection

• Weight data

  3 months after baseline data collection

Study Arms (1)

Self management education program

EXPERIMENTAL

The trained nurses will provide the self-management education program to the patients at the bedside by showing the educational videos and a textbook, at the 1st dialysis session after the intervention period starts. The nurses then provide the self-monitoring notebook at the 1st session and teach the patients how to record daily behavior on the notebook. Additionally, the nurses will teach the patients how to properly use various measurement tools, such as a weighing scale, blood pressure machine, water measurement cup, salt measuring spoon, food scale, and urine salt checker for daily monitoring. A measurement cup and a salt measuring spoon will be provided to each patient for free. Majority of patients do not have those tools, the nurses will encourage them to purchase the tools, or the researcher prepares these tools at the dialysis center and let the patients use them at the center. If appropriate, the nurses will rent equipment to patients, if possible.

Other: Self management education program

Interventions

Self management education program OTHER

After returning home, patients will be encouraged to practice their self-management behaviors and record the behavior and data to the self-monitoring notebook. At their next hemodialysis session, patients will bring their self-monitoring notebook, and the nurse will review the behavior and data, and offering feedback. The nurses will provide additional videos and education, and request the patients to share their experiences with other patients in the hemodialysis room. This cycle of education, self-monitoring, and feedback will continue with each hemodialysis session.

Self management education program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and older.
• Patients receive hemodialysis treatment at least once a week, irrespective of gender, causes of introduction of dialysis, and number of years since dialysis was introduced.

You may not qualify if:

• Patients with psychiatric disorders or cognitive impairments diagnosed by the medical doctor that may hinder their ability to participate in the educational sessions and self-management.
• Patients don't have shunt.
• Patients receiving additional dialysis treatment such as peritoneal dialysis

Sponsors & Collaborators

• Hiroshima University: lead

Study Sites (1)

Siem Reap Provencal Referral hospital

Siem Reap, Siem Reap, 171204, Cambodia

Location

Related Publications (4)

• Lightfoot CJ, Nair D, Bennett PN, Smith AC, Griffin AD, Warren M, Wilkinson TJ. Patient Activation: The Cornerstone of Effective Self-Management in Chronic Kidney Disease? Kidney Dial. 2022 Mar;2(1):91-105. doi: 10.3390/kidneydial2010012. Epub 2022 Mar 3.

  PMID: 37101653 BACKGROUND

• Weir MR. Hypervolemia and blood pressure: powerful indicators of increased mortality among hemodialysis patients. Hypertension. 2010 Sep;56(3):341-3. doi: 10.1161/HYPERTENSIONAHA.110.156588. Epub 2010 Jul 12. No abstract available.

  PMID: 20625072 BACKGROUND

• Lawless MT, Tieu M, Feo R, Kitson AL. Theories of self-care and self-management of long-term conditions by community-dwelling older adults: A systematic review and meta-ethnography. Soc Sci Med. 2021 Oct;287:114393. doi: 10.1016/j.socscimed.2021.114393. Epub 2021 Sep 10.

  PMID: 34534780 BACKGROUND

• Thomas B, van Pelt M, Mehrotra R, Robinson-Cohen C, LoGerfo J. An estimation of the prevalence and progression of chronic kidney disease in a rural diabetic cambodian population. PLoS One. 2014 Jan 22;9(1):e86123. doi: 10.1371/journal.pone.0086123. eCollection 2014.

  PMID: 24465909 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 12, 2025
• Study Start: April 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)