NCT05330221 Project 2: ACHIEVE- HF

Eligibility & Interventions

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This trial targets 364 participants in total. It began in 2023-01-18 with a primary completion date of 2026-06-30.

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.

Eligibility Criteria

Inclusion: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Detroit-area resident (defined as those who attended a Detroit-area community event) 2. ≥18 years of age 3. 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) 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

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