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NCT Number: NCT06907472

Diabetes Management for Primary Healthcare Centers.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deidei PHC, Bwari Area Council, Abuja, Federal Capital Territory, Nigeria

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About this study

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:

  • Healthy lifestyle counseling on clinic visits (Patient level).
  • Simplified treatment protocol for diabetes management (National policy level).
  • Access to functioning glucometers, test strips, and essential medicines (Health systems level).
  • Team-based care and trained Community health extension workers/nurses to provide Diabetes management and follow up care (Health workers & National Policy level).
  • Information system to support performance and quality reporting and Health facility improvement (Health facility level).
  • Diabetes patient registry and empanelment (Health system level).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: 1. Metformin 500mg [brand; Diamet 500mg by MAY & BAKER Nigeria PLC] 2. Glibenclamide 5mg [brand; Diatab 5mg by MAY & BAKER Nigeria PLC]

Primary outcomes

  1. Reach (Recruitment rate): defined as the proportion of patients enrolled per month per the monthly recruitment target.

    Time frame: 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%

  2. Adoption (adherence to protocol): defined as the proportion of diagnosed patients with diabetes started on treatment.

    Time frame: 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%.

  3. Maintenance (retention rate): defined as the proportion of patients who complete the six-month final visit of the implementation phase

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

University of Abuja

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • Northwestern University
  • Washington University School of Medicine

Registry information

Official study title

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

Acronym: DM4PHC-pilot

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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