NCT04755153: CIRCL-Chicago

Community Intervention to Reduce CardiovascuLar Disease in Chicago

Recruiting now NA Last updated 5 September 2025

What this trial tests

NA trial testing Practice Facilitation in Hypertension in 2,000 participants. Currently enrolling.

Timeline

7 January 2025

Primary endpoint
31 October 2027

31 March 2028

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	2,000
Start date	7 January 2025
Primary completion	31 October 2027
Estimated completion	31 March 2028
Sites	3 locations across United States

Drugs / interventions tested

• Practice Facilitation
• Non-Practice Facilitation

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Northwestern University

Who can join

Adults 18 to 89, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hypertension affects 1 in every 3 adults in the US and contributes to 410,000 deaths annually. Hypertension and its associated complications disproportionately affect minority populations living in urban areas. In Chicago, health status indicators show worsening disparities between black and white residents, with the highest rates of hypertension, heart disease, and stroke clustering in the predominantly black South and West Sides. Kaiser Permanente demonstrated that a bundle of evidence-based interventions implemented within a large, integrated health system in Northern California significantly increased blood pressure control rates. However, it is unclear whether a health system centered intervention can be adapted to other settings, particularly under-resourced urban communities. Therefore, the overall goal is to support a community-centered design and adaptation of the Kaiser bundle. The investigative team will adapt the delivery model of the Kaiser bundle to be centered within churches within the South Side of Chicago, one of the most medically underserved communities in the United States. The proposed interventions are the same as in the Kaiser bundle (e.g., registry/audit and feedback, simplified treatment regimens, accurate Blood Pressure measurement) but implementation of the components of the bundle will be adapted for delivery in the community. The intervention will be carried out by local community health workers and ministry facilitators, with health clinics and hospitals in the community as support, all connected through a common data platform.

Thus, the proposed project will identify the best strategies to support adoption, implementation with fidelity, and sustainability of the Kaiser bundle in the community setting. The proposed study will follow the Exploration, Preparation, Implementation and Sustainment (EPIS) process model and implementation is rigorously evaluated using a multimethod approach to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) evaluation framework. The specific aims are: Aim 1: Convene community stakeholders in order to adapt implementation strategies using the Dynamic Adaptation Process model. Aim 2: Design, implement, and evaluate pilot projects in order to optimize implementation strategies within the target community. Aim 3: Implement, test and evaluate an adapted implementation strategy to control hypertension through faith-based organizations in the South Side of Chicago. The study uses a hybrid Type 3 effectiveness-implementation design based within one primary community area (South Side Chicago) and in two settings (church and clinic). The overall study outcomes reach (implementation) and blood pressure (clinical effectiveness). Aim 4: Disseminate findings internally to community stakeholders and externally through creation of community implementation toolkits.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions and contextual factors to improve retention in care for patients with hypertension in primary care: Hermeneutic systematic review.
   Ye J, Sanuade OA, Hirschhorn LR, Walunas TL, et al · · 2024 · cited 11× · PMID 38301908 · DOI 10.1016/j.ypmed.2024.107880
2. Community intervention to reduce cardiovascular disease in Chicago (CIRCL-Chicago): protocol for a type 3 hybrid effectiveness-implementation study using a parallel cluster-randomized trial design.
   Smith JD, Carroll AJ, Tedla YG, Sanuade OA, et al · · 2025 · cited 1× · PMID 40325453 · DOI 10.1186/s13012-025-01431-w