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 — BEHAVIORAL
    Low 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 — OTHER
    High 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 risk
    PAL2
  • Other: High CVD risk
    Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA)

Primary Outcome Measure

Triple Goal [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Sanjay Rajagopalan, MD
216-844-5191

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