An interventional study of Self management education program in Chronic Kidney Disease on Hemodialysis, sponsored by Hiroshima University. Completed at 1 site in Cambodia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Hiroshima University · Not applicable, Interventional, and Other
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).
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.
Hiroshima University is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Time frame: 3 months after baseline data collection
Patient' knowledge
Patients' knowledge score, measured by the questionnaire developed by the research team (the same as the 1)) based on our educational booklet. The questionnaire has 25 items with "True", "False", and "Don't know" answers. True = 1 point, and "False" and "Don't know" = 0 point. Score range is from 0 to 25. The research team also input 3 additional questions include 3 examples of good protein-contain food, 3 example of rich in carbohydrate food, and 3 example of high potassium fruits.
Time frame: 3 months after baseline data collection
Quality of Life Measurement Using the EQ-5D-5L: A Five-Dimensional Assessment of Health Status
Quality of life: measured by the 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQoL group in 2009, and Khmer version was developed in 2011. The EQ-5D-5L have five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
Time frame: 3 months after baseline data collection
Self-monitoring
Self-monitoring: the data will be extracted from the patient self-monitoring notebook. Count the number of days in a month (30 or 31 days) that each self-care behavior was implemented and divide by the number of days in a month to produce a percentage. Baseline data will be calculated based on the implementation status in the month of consent.
Time frame: 3 months after baseline data collection
Blood pressure data
Blood pressure (in millimeters of mercury) is measured by the nurse when the patient arrives for dialysis. The average of blood pressure at the start of dialysis on the day of dialysis for that month (one month) will be calculated.
Time frame: 3 months after baseline data collection
Weight data
Weight (in kilograms) is measured by the nurse when the patient arrives for dialysis. The average of weight at the start of dialysis on the day of dialysis for that month (one month) will be calculated.
Time frame: 3 months after baseline data collection
Creatinine data
Creatinine level is collected from laboratory data in the patient record at both baseline and endline.
Time frame: 3 months after baseline data collection
Urea data
Urea level is collected from laboratory data in the patient record at both baseline and endline.
Time frame: 3 months after baseline data collection
Qualitative data
Qualitative data Once a month (preferably during the last week of dialysis), the nurse conducts an unstructured interview at the bedside with the patient on dialysis about his/her experiences and changes after participating in the program. Patients are free to describe their experiences and changes.
Time frame: 3 months after baseline data collection
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Hiroshima University