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临床试验/NCT06871553
NCT06871553已完成不适用

The Efficacy of the Self-Management Program on Knowledge and Self-Management Behavior of Hemodialysis Patients at Siem Reap Provincial Referral Hospital, Cambodia

Hiroshima University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Patients' self-management behavior

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Self management education program (Other)

结局指标

主要结局

Patients' self-management behavior

时间窗: 3 months after baseline data collection

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.

次要结局

  • Urea data(3 months after baseline data collection)
  • 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)
  • Creatinine data(3 months after baseline data collection)
  • Qualitative data(3 months after baseline data collection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hour Sovannara

Principal Investigator

Hiroshima University

研究点 (2)

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