Project 2: ACHIEVE- HF

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT05330221
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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
  • 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.

Study Details

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.

Key Dates

Start date
Jan 18, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
364 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Systolic blood pressure (BP) [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wayne State UniversityDetroitMichigan48201
Paul Kurian
[email protected]
(313) 448-9817

Find similar trials in Detroit, MI

By condition
Heart failureHypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Wayne State University· Detroit, MI

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