Clinical trial NCT06907472: Diabetes Management for Primary Healthcare Centers.
Official title: Integrating Diabetes Care Into Primary Healthcare Centers in Abuja, Nigeria: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Integrating Diabetes care
Primary Healthcare Center
pilot study
Abuja
Nigeria
Lead sponsor: University of Abuja
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: Northwestern University
name: Washington University School of Medicine
First posted: 2025-04-02
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a single-arm pilot trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Reach (Recruitment rate): defined as the proportion of patients enrolled per month per the monthly recruitment target.
timeFrame: Six months.
measure: Adoption (adherence to protocol): defined as the proportion of diagnosed patients with diabetes started on treatment.
timeFrame: Six months.
measure: Maintenance (retention rate): defined as the proportion of patients who complete the six-month final visit of the implementation phase
timeFrame: Six months.
Secondary outcomes:
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: Kagini PHC, Abuja Municipal Area council (AMAC)
state: FCT
city: Abuja
country: Nigeria
facility: Deidei PHC, Bwari Area Council
state: FCT
Study officials:
affiliation: University of Abuja
name: Ikechukwu A. Orji, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Abuja
name: Dike B. Ojji, MBBS, PhD
role: STUDY_CHAIR
affiliation: Northwestern University Chicago
name: Lisa R. Hirschhorn, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.