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Diabetes Management for Primary Healthcare Centers.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06907472
Acronym
DM4PHC-pilot
Enrollment
106
Registered
2025-04-02
Start date
2025-09-15
Completion date
2026-12-31
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Integrating Diabetes care, Primary Healthcare Center, pilot study, Abuja, Nigeria

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).

Interventions

DRUGProtocol-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

Sponsors

University of Abuja
Lead SponsorOTHER
Fogarty International Center of the National Institute of Health
CollaboratorNIH
Northwestern University
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The study is a single-arm pilot trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 of 18 participants per month. 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 phaseSix 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%.

Countries

Nigeria

Contacts

PRINCIPAL_INVESTIGATORIkechukwu A. Orji, MBBS, PhD

University of Abuja

STUDY_CHAIRDike B. Ojji, MBBS, PhD

University of Abuja

STUDY_DIRECTORLisa R. Hirschhorn, MD, MPH

Northwestern University Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026