Overview

Project 2: ACHIEVE- HF

Status:
Not yet recruiting
Trial end date:
2027-09-30
Target enrollment:
0
Participant gender:
All
Summary
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 2 of the ACHIEVE GREATER Center.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Henry Ford Health System
Collaborator:
Wayne State University
Criteria
Inclusion:

In order to be eligible to participate in this study, an individual must meet all of the
following criteria:

1. Self-identified Black/African American

2. Detroit-area resident (defined as those who attended a Detroit-area community event)

3. ≥18 years of age

4. At least one of the following:

A) Screening systolic BP ≥ 140 and/or diastolic BP ≥ 90 mm Hg OR

B) Screening BP 130-139 mm Hg plus >1 additional HF risk factors:

i. Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL/min/m2) OR C) Treated (1-2
antihypertensive medications) stage 1 HTN (systolic BP 130-139 and/or diastolic BP 80-89)
with or without >1 additional HF risk factors

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation
in this study:

1. Previous diagnosis of HF

2. Uncontrolled diabetes (HbA1C ≥8.0% from SOC screening labs)

3. Current use >2 anti-hypertensive medications (resistant hypertension)

4. Chronic use of insulin or >1 anti-diabetic medication

5. Self-reported pregnancy (or planning to become pregnant in the next year)

6. Severely uncontrolled BP at screening visits (SBP ≥180 mm Hg and/or diastolic BP >
110)

7. BNP ≥ 400 ng/L from SOC screening labs