ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center involves four 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, Projects 2 and 4) and coronary heart disease (CHD, Project 3). The first three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. Projects 1-3 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

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

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

• ≥18 years of age

• 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 OR

⁃ D) Treated stage 1 HTN w/ systolic BP 120-129 with additional HF risk factors:

⁃ i. Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL/min/m2)

Locations
United States
Michigan
Wayne State University
RECRUITING
Detroit
Contact Information
Primary
Whitney Cabral, MS
wcabral1@hfhs.org
313-874-1887
Time Frame
Start Date: 2023-01-18
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 364
Treatments
Experimental: Intervention Group
PAL2 Intervention~Drug Therapy
No_intervention: Usual Care Group
Participants that are randomized into usual care will be assisted with arrangement of follow-up, either with existing primary care provider (PCP) or a Wayne Health provider. All subsequent medical treatment will be at the discretion of the PCP.
Sponsors
Leads: Henry Ford Health System
Collaborators: Wayne State University

This content was sourced from clinicaltrials.gov