Project 2: ACHIEVE- HF

Not Applicable

Recruiting

• Conditions: Heart Failure; Hypertension
• Interventions: Behavioral: PAL2; Drug: PHARM-PAL2

• Registration Number: NCT05330221
• Lead Sponsor: Henry Ford Health System

Brief 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.

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Study Start: 2023-01-18
• Status Verified: 2024-08
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

Not provided

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. Chronic use of insulin or >1 anti-diabetic medication
4. Self-reported pregnancy (or planning to become pregnant in the next year)
5. Severely uncontrolled BP at screening visits (SBP ≥180 mm Hg and/or diastolic BP ≥110 mmHg)
6. Point of care (POC) BNP measurement ≥400 ng/L. If POC BNP was not obtained, then NTproBNP ≥ 1000 ng/L from screening labs will be excluded.
7. eGFR <45 ml/min/sq-m on SOC screening labs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	PAL2	PAL2 Intervention Drug Therapy
Intervention Group	PHARM-PAL2	PAL2 Intervention Drug Therapy

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure (BP)	12 months	Change in systolic BP at 12-months vs. baseline (detect ≥ 5 mm Hg difference). This will be determined by comparing the "post-trial systolic BP" at 12-month mobile health unit (MHU) visit versus the "baseline systolic BP" at screening MHU visit.
NT-proB-type Natriuretic Peptide (NT-proBNP)	12 months	Change in NT-proBNP over 12 months

Secondary Outcome Measures

Name	Time	Method
Utilization rates for anti-RAS medications and SGLT2 inhibitors	12 months	Utilization rates for anti-RAS medications (ACE-inhibitors, angiotensin receptor blockers, ARNi's) and SGLT2 inhibitors in the intervention group compared to usual care at the 12-month visit.
Geospatial outreach	24 months	Reach will be assessed by evaluating the number of patients who are screened by the MHUs; the number and percentage of screened patients who meet inclusion and exclusion criteria for ACHIEVE- HF; the number and percentage of patients who meet inclusion that enroll; and the number and percentage of enrolled patients who do and do not complete the study. For each of these measures, qualitative and quantitative methods will be utilized to understand how patient and community level characteristics may have contributed to higher or lower indicators of reach.

Trial Locations

Locations (1)

Wayne State University; 🇺🇸 Detroit, Michigan, United States