NCT04755153 Community Intervention to Reduce CardiovascuLar Disease in Chicago
| NCT ID | NCT04755153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2025-01-07 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Community: patients w/in participating clinics (by clinic location in community) OR within participating churches (by location in community) * Age: adults (18-89 y/o) Exclusion Criteria: * Children less that 18 years of age
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04755153 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04755153 currently recruiting?
Yes, NCT04755153 is actively recruiting participants. Contact the research team at jennifer.heinrich@northwestern.edu for enrollment information.
Where is the NCT04755153 trial being conducted?
This trial is being conducted at Chicago, United States, Chicago, United States, Chicago, United States.
Who is sponsoring the NCT04755153 clinical trial?
NCT04755153 is sponsored by Northwestern University. The trial plans to enroll 2,000 participants.