Diabetes Management for Primary Healthcare Centers.

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Interventions: Drug: Protocol-based treatment

• Registration Number: NCT06907472
• Lead Sponsor: University of Abuja

Brief 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).

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study Start: 2025-04-01
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Adults 18 years and older
• Uncomplicated type 2 diabetes mellitus

Exclusion Criteria

• Minors (younger than 18 years),
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm diabetes management in Primary Healthcare Centers [PHCs]	Protocol-based treatment	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.

Primary Outcome Measures

Name	Time	Method
Reach (Recruitment rate): defined as the proportion of patients enrolled per month per the monthly recruitment target.	Six months.	BENCHMARK: Achieving 50% of the monthly recruitment target. MEASUREMENT: Number of eligible patients recruited by participating PHCs per month divided by Monthly recruitment target x 100%
Adoption (adherence to protocol): defined as the proportion of diagnosed patients with diabetes started on treatment.	Six months.	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%.
Maintenance (retention rate): defined as the proportion of patients who complete the six-month final visit of the implementation phase	Six months.	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%.

Trial Locations

Locations (2)

Kagini PHC, Abuja Municipal Area council (AMAC); 🇳🇬 Abuja, FCT, Nigeria

Deidei PHC, Bwari Area Council; 🇳🇬 Abuja, FCT, Nigeria