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| ID | Type | Description | Link |
|---|---|---|---|
| D43TW011976 | U.S. NIH Grant/Contract | View source | |
| FHREC/2024/01/190/06-08-24 | Other Identifier | FCT Health Research Ethics Committee |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
| Northwestern University | OTHER |
| Washington University School of Medicine | OTHER |
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The purpose of this study, "Integrating diabetes care into Primary Healthcare Centers (PHCs) in Abuja, Nigeria: a pilot study," is to screen, diagnose, treat, and educate diabetes patients in two selected PHCs in Abuja. This single-arm pilot trial will test the feasibility of integrated diabetes care, measure the implementation outcomes, and explore the effectiveness of the strategy bundle using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
The pilot study involves the use of non-physician health workers (e.g., community health extension workers [CHEWs], nurses, and laboratory technicians) to implement a diabetes care program in alignment with the HEARTS diabetes-specific module, also known as HEARTS-D. The study adapted strategies from the Transforming Hypertension Treatment in Nigeria (HTN) Program, originally based on the Kaiser Permanente Northern California hypertension program and HEARTS technical package. The adapted intervention is informed by experience from the successful HTN program and findings from the investigators' formative assessment for this diabetes integration in the PHC setting.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm diabetes management in Primary Healthcare Centers [PHCs] | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocol-based treatment | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reach (Recruitment rate): defined as the proportion of patients enrolled per month per the monthly recruitment target. | BENCHMARK: Achieving 50% of the monthly recruitment target of 18 participants per month. MEASUREMENT: Number of eligible patients recruited by participating PHCs per month divided by Monthly recruitment target x 100% | Six months. |
| Adoption (adherence to protocol): defined as the proportion of diagnosed patients with diabetes started on treatment. | BENCHMARK: Achieving 80% treatment rate MEASUREMENT: The number of diagnosed patients with diabetes started on treatment divided by the total number of enrolled diabetes patients in the study x 100%. | Six months. |
| Maintenance (retention rate): defined as the proportion of patients who complete the six-month final visit of the implementation phase | BENCHMARK: Achieving a 50% retention rate. MEASUREMENT: The total number of patients who complete the six-month final visit divided by the total number of enrolled patients during the six months of implementation x 100%. | Six months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ikechukwu A. Orji, MBBS, PhD | University of Abuja | Principal Investigator |
| Dike B. Ojji, MBBS, PhD | University of Abuja | Study Chair |
| Lisa R. Hirschhorn, MD, MPH | Northwestern University Chicago | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kagini PHC, Abuja Municipal Area council (AMAC) | Abuja | Federal Capital Territory | 900106 | Nigeria | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35918703 | Result | 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. | |
| 33836719 |
| Label | URL |
|---|---|
| University of Abuja REDCap link to participant data set. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Individual patient data will be shared through NHLBI BioLINCC.
Data will be available within 1 year of study's conclusion.
Access to study data will be managed through NHLBI BioLINCC.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The study is a single-arm pilot trial.
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| Deidei PHC, Bwari Area Council |
| Abuja |
| Federal Capital Territory |
| 901101 |
| Nigeria |
| 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. |
| 38585872 | Result | 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. |
University of Abuja REDCap link to participant data set. |
| D004700 | Endocrine System Diseases |