Clinical trial NCT06189417: Effect Of Health Extension Worker-Led Based Interventions on Improving Self-Management Behavior Among Diabetic Patients in Ethiopia
Official title: Effect Of Health Extension Worker-Led Based Interventions on Improving Self-Management Behavior Among Diabetic Patients in Ethiopia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus, Self-management Behavior and Glycosylated Hemoglobin Levels
Keywords: Health Extension Worker, Self-Management Behavior, Club Based Intervention, People with diabetes
Lead sponsor: Debre Berhan University
Sponsor class: OTHER
Collaborators: name: University of South Africa
First posted: 2024-01-03
Enrollment: 560
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Upon completion of the baseline data collection for both groups, a total of 28 clusters/villages will be selected, each involving a maximum of 20 study participants. These clusters will be evenly distributed, with 14 clusters assigned to the intervention group and 14 clusters allocated to the control group. The HEW-led club-based intervention will be integrated into the health extension package. The intervention will take place once a week during club meetings, lasting approximately 50 minutes for six months. Across all clusters or villages, the intervention group will receive 14 educational sessions within a week.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean and proportion of diabetic self-management behavior
timeFrame: measured at six months
measure: Mean and proportion increase in glycemic control
timeFrame: measured at three and six months
Secondary outcomes:
measure: Acceptability of a community-based club intervention led by Health Extension Workers
timeFrame: measured at six months
Other outcomes:
Locations:
city: Debre Birhan
country: Ethiopia
facility: Debre Berhan University and North Shoa Zone Health Department
state: Amhara
Study officials:
affiliation: Debre Berhan University
name: Akine E Abosetugn, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: MoH., Realizing Universal Health Coverage through Primary Health Care: A Roadmap for Optimizing the Ethiopian Health Extension Program 2020 - 2035. Addis Ababa, Ethiopia: Ministry of Health, 2020. 2020.
citation: Bishu K.G, et al., Diabetes in Ethiopia: A systematic review of prevalence, risk factors, complications, and cost. Obesity Medicine, 2019. 15: p. 100132:https://doi.org/10.1016/j.obmed.2019.100132.
citation: Zeru MA, Tesfa E, Mitiku AA, Seyoum A, Bokoro TA. Prevalence and risk factors of type-2 diabetes mellitus in Ethiopia: systematic review and meta-analysis. Sci Rep. 2021 Nov 5;11(1):21733. doi: 10.1038/s41598-021-01256-9.
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citation: Dagnew B, Debalkie Demissie G, Abebaw Angaw D. Systematic Review and Meta-Analysis of Good Self-Care Practice among People Living with Type 2 Diabetes Mellitus in Ethiopia: A National Call to Bolster Lifestyle Changes. Evid Based Complement Alternat Med. 2021 Feb 20;2021:8896896. doi: 10.1155/2021/8896896. eCollection 2021.
citation: Ansari R M, et al., Implementation of Chronic Care Model for Diabetes Self-Management: A Quantitative Analysis. Diabetology, 2022. 3(3): p. 407-422.
citation: Ketema DB, Leshargie CT, Kibret GD, Assemie MA, Alamneh AA, Kassa GM, Alebel A. Level of self-care practice among diabetic patients in Ethiopia: a systematic review and meta-analysis. BMC Public Health. 2020 Mar 12;20(1):309. doi: 10.1186/s12889-020-8425-2.
citation: FDREMoH, National Strategic Plan for the Prevention And Control Of Major Non-Communicable Diseases, 2013-2017(2020/21-2024/25), Addis Ababa Ethiopia; July 2020. 2020.