NCT06907472

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

March 14, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 14, 2025

Last Update Submit

March 25, 2026

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Integrating Diabetes carePrimary Healthcare Centerpilot studyAbujaNigeria

Outcome Measures

Primary Outcomes (3)

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

    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%

    Six months.

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

    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%.

    Six months.

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

    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%.

    Six months.

Study Arms (1)

Single arm diabetes management in Primary Healthcare Centers [PHCs]

EXPERIMENTAL

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.

Drug: Protocol-based treatment

Interventions

Protocol-based treatmentDRUG

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

Also known as: 1. Metformin 500mg [brand; Diamet 500mg by MAY & BAKER Nigeria PLC] 2. Glibenclamide 5mg [brand; Diatab 5mg by MAY & BAKER Nigeria PLC]
Single arm diabetes management in Primary Healthcare Centers [PHCs]

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kagini PHC, Abuja Municipal Area council (AMAC)

Abuja, Federal Capital Territory, 900106, Nigeria

Location

Deidei PHC, Bwari Area Council

Abuja, Federal Capital Territory, 901101, Nigeria

Location

Related Publications (3)

  • 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.

    PMID: 35918703RESULT

  • 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.

    PMID: 33836719RESULT

  • 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.

    PMID: 38585872RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ikechukwu A. Orji, MBBS, PhD

    University of Abuja

    PRINCIPAL INVESTIGATOR

  • Dike B. Ojji, MBBS, PhD

    University of Abuja

    STUDY CHAIR

  • Lisa R. Hirschhorn, MD, MPH

    Northwestern University Chicago

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The study is a single-arm pilot trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-Doctoral Research Fellow

Study Record Dates

First Submitted

March 14, 2025

First Posted

April 2, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

December 14, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual patient data will be shared through NHLBI BioLINCC.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be available within 1 year of study's conclusion.
Access Criteria
Access to study data will be managed through NHLBI BioLINCC.
More information

Available IPD Datasets

Individual Participant Data Set Access

Locations

NG(2)