Clinical trial NCT06871553: The Self-management Program on Hemodialysis Patients in Cambodia
Official title: The Efficacy of the Self-Management Program on Knowledge and Self-Management Behavior of Hemodialysis Patients At Siem Reap Provincial Referral Hospital, Cambodia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease on Hemodialysis
Lead sponsor: Hiroshima University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

Detailed description: In Cambodia, the prevalence of CKD among the adult population is estimated at 1.2% (approximately 0.12 million) and the number of ESKD is unknown. However, in 2018, patient around 900 which is 8.9% were new patients received hemodialysis. The prevalence of people living with ESKD and treatment with hemodialysis has been increasing each year. Nearly a haft of hemodialysis patients in Cambodia (47%) receives hemodialysis treatment twice a week and other patients receive irregular hemodialysis. As a result, many patients in Cambodia are unable to adhere the recommended guideline. Additionally, around 90 % patients experience complication before and during hemodialysis session such as fluid overload, weakness, pale, and hypertension, according to a report from Siem Reap Provincial Referral Hospital 2023.

Patient education is a process that empowers patients, and their families to learn about health conditions, treatment options, and self-management strategies. Self-management is a critical approach for patients undergoing hemodialysis. Effective patient education can enhance patients' understanding of their condition, empower them to engage in behaviors that promote self-management, and reduce complications before, during and after hemodialysis treatment.

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 at Siem Reap Provincial Referral Hospital, Cambodia. By providing targeted education on basic of disease, basic of hemodialysis, its complication, reading laboratory data, medication adherence and daily care.

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.

The study will be conducted at Siem Reap Provincial Referral Hospital, Cambodia. The study population consists of patients undergoing hemodialysis in this hospital, who meet the criteria. The written informed consent will be taken from patients.

Convenience sampling will be employed to recruit participants, with patients selected based on their availability and willingness to take part in the study. All eligible patients who meet the inclusion criteria will be invited to participate. The sample size was calculated by using the G\*Power 3.1.9.7 software, 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).

Data analysis will be performed using statistical software SPSS. A descriptive and inferential statistical analysis will be used to address the research objectives. Descriptive statistics will summarize baseline sociodemographic and clinical history. All data will be counted and distribution, mean and standard deviation (SD) will be calculated. Reliability will be tested using Cronbach's alpha on both the self-management questionnaire and the knowledge questionnaire. Factor analysis will also be conducted on the self-management questionnaire. The results of each questionnaire at each point will be examined for mean, SD, and normality. Paired t-test will use to compare the different mean score of self-management, knowledge, QoL, self-monitoring, and physical and laboratory data at baseline and endline. One-way repeated ANOVA or Friedman's test after checking the normality on self-monitoring and physical and laboratory data. Relations among knowledge, self-management behavior, self-monitoring, physical and laboratory data, and QoL will be assessed by regression analysis and correlations. Qualitative data will be transcribed, coded, and categorized for understanding patient's experience and chanted. Statistical significance will be set as \< 0.05.

Through participation in this study, hemodialysis patients will develop comprehensive knowledge, enhancing their self-management behaviors, and empowering them to manage their condition independently. The statistically significant result of this study can be provided a foundation for the development of education programs across Cambodia, ultimately improving the QOL for CKD patients undergoing hemodialysis.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patients' self-management behavior
timeFrame: 3 months after baseline data collection
Secondary outcomes:
measure: Patient' knowledge
timeFrame: 3 months after baseline data collection
measure: Quality of Life Measurement Using the EQ-5D-5L: A Five-Dimensional Assessment of Health Status
timeFrame: 3 months after baseline data collection
measure: Self-monitoring
timeFrame: 3 months after baseline data collection
measure: Blood pressure data
timeFrame: 3 months after baseline data collection
measure: Weight data
timeFrame: 3 months after baseline data collection
measure: Creatinine data
timeFrame: 3 months after baseline data collection
measure: Urea data
timeFrame: 3 months after baseline data collection
measure: Qualitative data
timeFrame: 3 months after baseline data collection
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.