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
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RECRUITING
NA
106 participants
INTERVENTIONAL
2025-09-15
2026-12-14
Brief Summary
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Detailed Description
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The investigators used an adapted Service Availability and Readiness Assessment (SARA) instrument for the formative assessment and evaluated the PHC's availability and readiness for diabetes care across various domains. These domains include staffing, training, equipment, medications, clinical guidelines, health management information systems, and diabetes care services. The formative study also assessed health workers' knowledge, attitudes, and practices related to diabetes care and explored barriers and facilitators of implementing diabetes treatment programs at the PHC setting. The findings from the formative work informed the development and adaptation of strategies for this pilot implementation. The investigators are leveraging the available non-physician health workers and paper-based health management information systems, strengthening diabetes screening and counselling services, providing adequate training and re-training of health workers to provide comprehensive diabetes care services, providing diabetes education materials and job aids, and improving access to diabetes medications. The strategy is designed to overcome modifiable barriers at patient and system levels in the cascade of care for diabetes care at the PHC setting in Nigeria.
This pilot study will deliver a multi-level implementation package for diabetes care, which includes:
1. Healthy lifestyle counseling on clinic visits (Patient level).
2. Simplified treatment protocol for diabetes management (National policy level).
3. Access to functioning glucometers, test strips, and essential medicines (Health systems level).
4. Team-based care and trained Community health extension workers/nurses to provide Diabetes management and follow up care (Health workers \& National Policy level).
5. Information system to support performance and quality reporting and Health facility improvement (Health facility level).
6. Diabetes patient registry and empanelment (Health system level).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Single arm diabetes management in Primary Healthcare Centers [PHCs]
Single-arm diabetes treatment in two PHCs. The two PHCs will implement a contextually and culturally adapted package based on the WHO HEARTS-D package for screening, diabetes diagnosis, patient education, and treatment using a HEARTS-D-adapted treatment protocol.
Protocol-based treatment
PROTOCOL:
Step 1: Metformin 500 mg daily Step 2: Metformin 1000 mg daily Step 3: Metformin 1000 mg twice daily Step 4: Metformin 1000 mg twice daily + glibenclamide 5 mg daily Step 5: Metformin 1000 mg twice daily + glibenclamide 5 mg twice daily
Interventions
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Protocol-based treatment
PROTOCOL:
Step 1: Metformin 500 mg daily Step 2: Metformin 1000 mg daily Step 3: Metformin 1000 mg twice daily Step 4: Metformin 1000 mg twice daily + glibenclamide 5 mg daily Step 5: Metformin 1000 mg twice daily + glibenclamide 5 mg twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Uncomplicated type 2 diabetes mellitus
Exclusion Criteria
* Type 1 diabetes mellitus
* Prisoners
* Other detained individuals
* Severe hypertension (SBP ≥180 mmHg and DBP ≥ 110 mmHg)
* Prior history of complications: stroke, heart failure, chronic kidney disease, diabetic foot ulcer.
* Pregnant women.
* Older patients above 60 years of age with uncontrolled plasma glucose at the maximum dose of metformin (2 g/day) and maximum dose of glibenclamide (5mg/day) at entry to the study.
18 Years
99 Years
ALL
No
Sponsors
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University of Abuja
OTHER
Fogarty International Center of the National Institute of Health
NIH
Northwestern University
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Ikechukwu Anthony Orji
Post-Doctoral Research Fellow
Principal Investigators
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Ikechukwu A. Orji, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Abuja
Dike B. Ojji, MBBS, PhD
Role: STUDY_CHAIR
University of Abuja
Lisa R. Hirschhorn, MD, MPH
Role: STUDY_DIRECTOR
Northwestern University Chicago
Locations
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Kagini PHC, Abuja Municipal Area council (AMAC)
Abuja, Federal Capital Territory, Nigeria
Deidei PHC, Bwari Area Council
Abuja, Federal Capital Territory, Nigeria
Countries
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Central Contacts
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Facility Contacts
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Ikechukwu A. Orji, MBBS, PhD
Role: primary
Dike B. Ojji, MBBS, PhD
Role: backup
Ikechukwu A. Orji, MBBS, PhD
Role: primary
Dike B. Ojji, MBBS, PhD
Role: backup
References
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Baldridge AS, Aluka-Omitiran K, Orji IA, Shedul GL, Ojo TM, Eze H, Shedul G, Ugwuneji EN, Egenti NB, Okoli RCB, Ale BM, Nwankwo A, Osagie S, Ye J, Chopra A, Sanuade OA, Tripathi P, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial. Implement Sci Commun. 2022 Aug 2;3(1):84. doi: 10.1186/s43058-022-00328-9.
Orji IA, Baldridge AS, Omitiran K, Guo M, Ajisegiri WS, Ojo TM, Shedul G, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Capacity and site readiness for hypertension control program implementation in the Federal Capital Territory of Nigeria: a cross-sectional study. BMC Health Serv Res. 2021 Apr 9;21(1):322. doi: 10.1186/s12913-021-06320-8.
Orji IA, Baldridge AS, Ikechukwu-Orji MU, Banigbe B, Eze NC, Chopra A, Omitiran K, Iyer G, Odoh D, Alex-Okoh M, Reng R, Hirschhorn LR, Huffman MD, Ojji DB. Evaluation of Primary Healthcare Centers' Service Availability and Readiness for Implementing Diabetes Care in Abuja, Nigeria: A Cross-Sectional, Formative Assessment. Res Sq [Preprint]. 2024 Mar 26:rs.3.rs-3959541. doi: 10.21203/rs.3.rs-3959541/v1.
Study Documents
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Document Type: Individual Participant Data Set
View DocumentRelated Links
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University of Abuja REDCap link to participant data set.
Other Identifiers
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FHREC/2024/01/190/06-08-24
Identifier Type: OTHER
Identifier Source: secondary_id
UATH/HREC/PR/505
Identifier Type: -
Identifier Source: org_study_id