Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2022-08-15
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Low CVD risk
PAL2
PAL2
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.
High CVD risk
Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA)
CINEMA
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.
Interventions
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PAL2
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Self-identified as Black or African American
3. Residence in the Cleveland Metro Area
4. Must have at least two of the following risk factors identified at a UH health fair screenings, with one risk factor being with SBP, A1c, or LDL:
1. BMI≥30 mg/dL
2. History of smoking
3. Elevated blood pressure defined as SBP\>140 or DBP\>80 mmHg
4. HbA1c≥5.7%
5. LDL≥130
5. Able to complete a coronary artery calcium score test (CAC)
6. Willing and able to consent
7. Willing to have a UH provider and UH care
8. Currently insured for standard of care procedures
Exclusion Criteria
2. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg
3. Lung disease requiring supplemental oxygen therapy
4. Individuals receiving treatment for cancer related disease
5. Pregnant or nursing mothers
40 Years
75 Years
ALL
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Sanjay Rajagopalan
Chief, Cardiovascular Medicine, Chief Academic and Scientific Officer
Principal Investigators
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Sanjay Rajagopalan, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY20220763
Identifier Type: -
Identifier Source: org_study_id
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