About this trial
Last updated a year ago
Study ID
IRB-22-01-4343
Status
Terminated
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18 to 95 Years
All
Trial Timing
Ended a year ago
What is this trial about?
This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities
by 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 1 of the ACHIEVE GREATER Center
What are the participation requirements?
Inclusion Criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Self-identified Black/African Americans
2. Detroit-area residents (defined as those who attend attended a Detroit-area community event)
3. > 18 years of age
4. Screening systolic BP 130-139 and diastolic BP < 90 mm Hg
5. Not currently taking medications for HTN (Untreated)
6. 10-year cardiovascular risk < 10% per ASCVD calculator (as such nearly all patients will be <50-55 years of age)
7. Baseline home systolic BP 120-159 mm Hg and diastolic BP < 100 mm Hg
Exclusion Criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
1. History of clinical cardiovascular disease (CVD)
2. History of kidney disease or eGFR <60 mL/min from screening labs
3. Self-reported pregnancy (or planning to be pregnant in the next year)
4. History of diabetes or HbA1c > 6.5% from SOC screening labs
5. Non-HDL-C > 220 mg/dL from SOC labs (potential genetic hyperlipidemia)
6. Arm circumference > 18'' (home BP arm cuff will be inaccurate)
7. Baseline home BP average > 160mm Hg systolic and/or >100 mm Hg diastolic