Project 3: ACHIEVE- CHD
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- University Hospitals Cleveland Medical Center
- Study ID
- NCT05918380
- Status
- Recruiting
Conditions
- Coronary Heart Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- PAL2 — BEHAVIORALLow CVD risk participants (CAC \< 100) will be followed by their primary care provider accompanied by monthly contact with community health workers provided by ACHIEVE Greater who will screen participants for social determinants of health and implement the PAL2. PAL2 is defined as a community health worked based intervention to mitigate psychosocial and health equity barriers to optimize health promotion coupled with high blood pressure and lifestyle disease state education.
- CINEMA — OTHERHigh CVD risk participants (CAC ≥ 100) will be followed by specialists in the Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) at UHCMC. While they too will be assessed, by the CHW for SDOH and a plan developed to address them, this plan will be addressed by the usual resources available in the CINEMA clinic.
Study Details
This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center will involve three separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 3 of the ACHIEVE GREATER Center.
Key Dates
- Start date
- Aug 15, 2022
- Status verified
- Jun 2025
- Primary completion
- Jan 1, 2027
- Completion
- Jan 1, 2027
Study Design
- Enrollment
- 500 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Other: Low CVD riskPAL2
- Other: High CVD riskCenter for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA)
Primary Outcome Measure
Triple Goal [ Time Frame: 12 months ]
Central Contacts
- Sanjay Rajagopalan, MD216-844-5191
- Heidi Osborne216-844-2833
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 |
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