NCT05330221

Project 2: ACHIEVE- HF

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 364 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Heart failure (HF) is one of the most common, costly, and deadly diseases affecting humans. Hypertension is the largest single risk factor for HF, accounting for over half of all new cases. Accordingly, early interventions to prevent HF, in particular blood pressure (BP) control, are critical. However, implementation of effective treatments remains suboptimal, especially in Detroit, Michigan. To better engage the at-risk community, the team developed an innovative mobile health unit (MHU) program that uses geospatial health and area-level exposure data to direct health services to communities in highest need, who may not otherwise engage with traditional health care settings. Another key to preventing HF is usage of guideline-directed medical therapy (GDMT), not only for treating high BP, but also providing medications proven to reduce HF incidence. In particular, inhibitors of sodium-glucose transporter type 2 (SGLT2) prevent HF and loss of kidney function in at-risk patients. Yet, these are dramatically under-utilized, further contributing to health disparities. Project 2 of ACHIEVE GREATER uses a pragmatic, randomized, unblinded, clinical trial to implement and test a novel intervention leveraging our MHU platform to improve care access combined with enhanced collaborative care delivery among patients with Stage A HF (defined as asymptomatic individuals with known pre-conditions such as hypertension who are at-risk for later-stage clinical HF). The key components of the program are 1) a personalized intervention conducted by community health workers that links patients with available community resources, and 2) pharmacist-directed therapy optimization per a standardized GDMT protocol. This intervention will address multiple domains and levels of impact to reduce the large gaps in care of stage-A HF patients in the community and prevent progression towards symptomatic HF.

Conditions

• Heart Failure
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	PAL2	Community health worked based intervention to mitigate psychosocial and life circumstance barriers to optimize health promotion coupled with high blood pressure and lifestyle disease state education Other Names: Pragmatic personalized, adaptable approach to lifestyle and life circumstance
DRUG	PHARM-PAL2	All intervention arm participants will be referred to our study pharmacist who will prescribe a antihypertensive medication as per standard of care medical treatment algorithm to achieve BP control. Per AHA recommended guidelines, participants with an indication of diabetes mellitus (DM) and/or CKD will be started on SGLT2 inhibitor within the first month of starting the study intervention.

Timeline

• Start date: 2023-01-18
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2022-04-15
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States