Effect Of Health Extension Worker-Led Based Interventions on Improving Self-Management Behavior Among Diabetic Patients in Ethiopia
NCT ID: NCT06189417
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
560 participants
INTERVENTIONAL
2024-02-01
2025-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of a Diabetes Self-management Coaching Program for Type 2 Diabetes Patients in the Ethiopian PC.
NCT05336019
Diabetes Self-Management Education (DSME) and Its Effect on Clinical, Psychosocial, and Behavioral Outcomes
NCT03185689
Effect of Diabetes Self-management Education and Support on Glycemic Control Among Patients With Type 2 Diabetic
NCT06325917
The Influence of Conversation Map on the Health Behaviors of Diabetes Patients
NCT02977130
Effect of Peer Support Intervention on Medication Adherence, Self-care and Knowledge Among Patients With Diabetes
NCT07145983
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group
A total of 280 study participants are allocated to intervention group
Health Extension Led club based Intervention
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.
control group
A total of 280 study participants are allocated to control group
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Health Extension Led club based Intervention
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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, based on medical assessment by their physician, are deemed unable to participate in the intervention
* Patients who choose not to continue with the intervention.
20 Years
79 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of South Africa
OTHER
Debre Berhan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Akine Eshete
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Akine E Abosetugn, MPH
Role: PRINCIPAL_INVESTIGATOR
Debre Berhan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Debre Berhan University and North Shoa Zone Health Department
Debre Berhan, Amhara, Ethiopia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Mulugeta TK, Kassa DH. Readiness of the primary health care units and associated factors for the management of hypertension and type II diabetes mellitus in Sidama, Ethiopia. PeerJ. 2022 Aug 25;10:e13797. doi: 10.7717/peerj.13797. eCollection 2022.
Tesema AG, Peiris D, Abimbola S, Ajisegiri WS, Narasimhan P, Mulugeta A, Joshi R. Community health extension workers' training and supervision in Ethiopia: Exploring impact and implementation challenges for non-communicable disease service delivery. PLOS Glob Public Health. 2022 Nov 9;2(11):e0001160. doi: 10.1371/journal.pgph.0001160. eCollection 2022.
American Diabetes Association. Standards of Medical Care in Diabetes-2021 Abridged for Primary Care Providers. Clin Diabetes. 2021 Jan;39(1):14-43. doi: 10.2337/cd21-as01. No abstract available.
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.
Ansari R M, et al., Implementation of Chronic Care Model for Diabetes Self-Management: A Quantitative Analysis. Diabetology, 2022. 3(3): p. 407-422.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-005/23
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.