Effect Of Health Extension Worker-Led Based Interventions on Improving Self-Management Behavior Among Diabetic Patients in Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- Mean and proportion of diabetic self-management behavior
研究概览
简要总结
Despite the existence of lifestyle interventions designed to encourage self-management behaviors, the difficulty of adhering to recommended practices remains a widespread issue globally, including in Ethiopia. Traditional approaches to care have demonstrated limited effectiveness in promoting self-management behavior. As a potential solution, a Health Extension Worker-Led club-based intervention has been implemented. Therefore, the aim of this study is to assess the impact of the Health Extension Worker-Led club-based intervention on improving self-management behaviors and glycemic control.
The study will utilize a parallel-group, cluster randomized controlled trial design to investigate its objectives. The main focus of the research is to assess the average increase, both in terms of mean and percentage, in adherence to self-management behaviors and glycemic control. Additionally, the study aims to evaluating the acceptance of the intervention. To evaluate the impact of a Health Extension Worker-led intervention on self-management behavior and levels of glycosylated hemoglobin (HbA1C), a difference-in-difference analysis will be employed. A comparison of the intervention's effects across different groups will be conducted using an independent-sample t-test.
详细描述
Despite the Ethiopian government's focus on non-communicable diseases, diabetes is increasingly becoming a major public health issue among adults. Unfortunately, diabetes care in numerous countries, including Ethiopia, is inadequate, resulting in undiagnosed cases, low rates of diabetes control, and failure to meet established care standards.
Insufficient readiness of healthcare services, inadequate training of healthcare professionals, and a lack of patient-centered interventions have contributed to inadequate healthcare coverage and suboptimal self-management behavior. The inadequate adherence to self-management behavior has become a critical issue, with half of the patients failing to comply in Ethiopia. Several systematic reviews and meta-analyses consistently indicate that the range for achieving good diabetes self-management behavior is between 49.8% and 51.12%.
To ensure the provision of high-quality diabetes care, it is vital to prioritize patient preferences and needs by adopting a patient-centered approach. The implementation of community-based care programs that prioritize patient-centeredness and aim to enhance patients' understanding of self-care management is of utmost importance. Published evidence strongly indicates that educational interventions can play a significant role in supporting individuals with diabetes to improve their self-care management.
The existing delivery approaches in various countries, including Ethiopia, are insufficient in facilitating the adoption of recommended self-care practices. Therefore, there is an urgent need to implement patient-centered care programs at the community level. To address this issue, a Health Extension Worker-Led club-based intervention has been introduced as a strategic intervention approach to fill this gap. The Health Extension Worker-led club-based intervention is seamlessly integrated into the existing Health Extension Program. The introduction of a community-based intervention has a significant impact on self-management behavior, improves access to chronic disease services, and enhances outcomes for individuals with chronic diseases.
To the best of our knowledge, there is a lack of evidence regarding the impact of a Health Extension Worker-led club based intervention on self-management behaviors in Ethiopia. Therefore, the objective of this study is to assess the impact of the Health Extension Worker (HEW)-led club-based intervention on improving self-management behaviors, glycemic control, and the acceptance of the intervention among individuals with diabetes in Ethiopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All clusters of study participants will be geographically isolated, and ensuring that intervention and control groups are not exposed to each other. Study participants, HEW and HDA, will be blinded to the outcome interest of the study to avoid the hawthorn effect.
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetes who have provided informed consent
- •Patients with diabetes who do not have any other diabetes-related health complications at the start of the study
- •Patients with diabetes who are not pregnant
- •Patients with diabetes who have completed six months in the study
- •Patients with diabetes who have expressed their intention to remain within the study facility (health post) and community.
排除标准
- •Patients who decline to provide consent
- •Patients who, based on medical assessment by their physician, are deemed unable to participate in the intervention
- •Patients who choose not to continue with the intervention.
结局指标
主要结局
Mean and proportion of diabetic self-management behavior
时间窗: measured at six months
The proportion of self-management behaviors will be determined using the Diabetes Self-Care Activity Summary tool. Participants will be requested to report the frequency of these specific behaviors per week using an eight-point Likert scale, ranging from 0 to 7 days. The responses obtained through this scale will be utilized to compute an overall score, with higher average scores indicating greater adherence to self-management behaviors and practices. The study will compare the mean change in self-management behaviors at six months from baseline among the different groups.
Mean and proportion increase in glycemic control
时间窗: measured at three and six months
Fasting blood sugar (FBS) and Glycosylated hemoglobin (HbA1C) are widely utilized measures to assess glycemic control. The baseline FBS analysis involves calculating the mean of FBS measurements taken over three consecutive months. During the follow-up period, the analysis is conducted using the mean values of FBS measurements taken over six consecutive months. According to the guideline recommendations of the American Diabetes Association (ADA), glycemic status is considered good if the mean FBS falls between 80 and 130 mg/dL. Glycosylated hemoglobin (HbA1C) levels will be assessed at two time points: three months during follow up and six months after the intervention. The optimal range for glycosylated hemoglobin (HbA1C) levels for individuals with diabetes is below 7% (53 mmol/mol).
次要结局
- Acceptability of a community-based club intervention led by Health Extension Workers(measured at six months)
研究者
Akine Eshete
Principal Investigator
Debre Berhan University