Project 1: ACHIEVE- HTN

NCT05295758 | Terminated

• 1 other identifier: IRB-22-01-4343
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center will involve three 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, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will 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 1 of the ACHIEVE GREATER Center

Conditions

Hypertension; Undiagnosed Diseases

Keywords

Health Disparities; African American; Prevention

Outcome Measures

Primary Outcomes (2)

• Home systolic blood pressure (BP)

  Change in home systolic BP at 12-months versus baseline (detect ≥ 3 mm Hg difference). This will be determined by comparing the "post-trial home systolic BP" (7-day average) versus the "baseline home systolic BP" (7-day average).

  12 months

• Blood pressure control rate

  Percentage of study participants who achieve blood pressure control (\< 130/80) at 12 months compared to baseline.

  12 months

Secondary Outcomes (4)

• BP control without medication use

  12 Months

• Population reach

  12 months

• Durability of BP control over 2 years

  24 months

• Home diastolic BP

  12months

Other Outcomes (2)

• Patient wellbeing

  12 months

• Cost effectiveness

  12 months

Study Arms (1)

PAL2 Intervention

EXPERIMENTAL

Overall study cohort will be enrolled into non-randomized active treatment

Behavioral: PAL2

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

PAL2 Intervention

Eligibility Criteria

• Age: 18 Years - 95 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:
• Self-identified Black/African Americans
• Detroit-area residents (defined as those who attend attended a Detroit-area community event)
• \> 18 years of age
• Screening systolic BP 130-139 and diastolic BP \< 90 mm Hg
• Not currently taking medications for HTN (Untreated)
• year cardiovascular risk \< 10% per ASCVD calculator (as such nearly all patients will be \<50-55 years of age)
• Baseline home systolic BP 120-159 mm Hg and diastolic BP \< 100 mm Hg

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• History of clinical cardiovascular disease (CVD)
• History of kidney disease or eGFR \<60 mL/min from screening labs
• Self-reported pregnancy (or planning to be pregnant in the next year)
• History of diabetes or HbA1c \> 6.5% from SOC screening labs
• Non-HDL-C \> 220 mg/dL from SOC labs (potential genetic hyperlipidemia)
• Arm circumference \> 18'' (home BP arm cuff will be inaccurate)
• Baseline home BP average \> 160mm Hg systolic and/or \>100 mm Hg diastolic

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Hypertension; Undiagnosed Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiovascular Prevention Professor of Medicine

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 25, 2022
• Study Start: November 18, 2022
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

US (1)