NCT06907472

Diabetes Management for Primary Healthcare Centers.

Integrating Diabetes Care Into Primary Healthcare Centers in Abuja, Nigeria: A Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: University of Abuja · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 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

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-06-15
• Completion: 2026-12-14
• First posted: 2025-04-02
• Last updated: 2026-03-27

Locations

2 sites across 1 country: Nigeria