An interventional study of Health Extension Led club based Intervention in Diabetes Mellitus, Self-management Behavior and Glycosylated Hemoglobin Levels, sponsored by Debre Berhan University. Enrolling by invitation at 1 site in Ethiopia. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Debre Berhan University · Not applicable, Interventional, and Prevention
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.
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 560 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Debre Berhan University is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A total of 280 study participants are allocated to intervention group
Behavioral: Health Extension Led club based Intervention
A total of 280 study participants are allocated to control group
The Health Extension Workers-led club-based intervention primarily focuses on equipping individuals with the necessary knowledge and skills to enhance their self-management behavior. The intervention encompasses education on adopting healthy eating habits, promoting regular exercise, effectively managing weight, and supporting smoking cessation. It emphasizes the importance of regular blood sugar level monitoring, limiting alcohol intake, and reducing sedentary behavior. The intervention also includes counseling to provide guidance and support in adopting and maintaining healthy behaviors. Additionally, it highlights the significance of adhering to medication regimens for optimal health outcomes. If additional medical attention is required, the intervention provides referral services to nearby health facilities.
Mean and proportion of diabetic self-management behavior
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.
Time frame: measured at six months
Mean and proportion increase in glycemic control
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).
Time frame: measured at three and six months
Acceptability of a community-based club intervention led by Health Extension Workers
Acceptability, in this context, refers to the extent to which the intervention is perceived as appropriate, suitable, and desirable by the participating individuals. It assesses the community's willingness to actively engage with and adhere to the intervention, as well as their satisfaction and comfort with the intervention activities and delivery methods. To measure acceptability, participants will be asked to indicate their agreement with a series of statements related to the intervention using a five-point Likert scale, ranging from 1 to 5. The responses obtained through this scale will be utilized to compute an overall score, with higher average scores indicating greater acceptance level. Open-ended questions will also be included to gather participants' perspectives on the intervention content, their experiences with the HEW-led club intervention, and any suggestions for improvement.
Time frame: measured at six months
Plan to share: No
Started Feb 2024 (actual). Primary completion is estimated for Feb 2025, 12 months after the start.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 12 months is below that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Debre Berhan University