Project 2: ACHIEVE- HF

NCT05330221 | Recruiting

• 1 other identifier: WSU22115
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Hypertension

Keywords

Prevention; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Systolic blood pressure (BP)

  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.

  12 months

• NT-proB-type Natriuretic Peptide (NT-proBNP)

  Change in NT-proBNP over 12 months

  12 months

Secondary Outcomes (2)

• Utilization rates for anti-RAS medications and SGLT2 inhibitors

  12 months

• Geospatial outreach

  24 months

Other Outcomes (9)

• Patient satisfaction

  24 months

• Patient wellbeing

  24 months

• Cost effectiveness

  12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

PAL2 Intervention Drug Therapy

Behavioral: PAL2; Drug: PHARM-PAL2

Usual Care Group

NO INTERVENTION

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.

Interventions

PAL2 BEHAVIORAL

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

Intervention Group

PHARM-PAL2 DRUG

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Previous diagnosis of HF
• Uncontrolled diabetes (HbA1C ≥8.0% from SOC screening labs)
• Chronic use of insulin or \>1 anti-diabetic medication
• Self-reported pregnancy (or planning to become pregnant in the next year)
• Severely uncontrolled BP at screening visits (SBP ≥180 mm Hg and/or diastolic BP ≥110 mmHg)
• 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.
• eGFR \<45 ml/min/sq-m on SOC screening labs

Sponsors & Collaborators

• Henry Ford Health System: lead
• Wayne State University: collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Hypertension

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Whitney Cabral, MS

CONTACT

313-874-1887; wcabral1@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head - Advanced Heart Failure and Transplant Cardiology

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 15, 2022
• Study Start: January 18, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)