Linkage, Empowerment, and Access to Prevent Hypertension

NCT ID: NCT05061108

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-08
• Study Completion Date: 2026-09-30

Brief Summary

Brief Summary:

Black adults have a higher incidence of hypertension (HTN) and a greater risk of HTN-related cardiovascular disease (CVD) compared with White adults. Even mild elevations in blood (BP) above 115/75 mm Hg are associated with increased CVD risk. Accordingly, emphasis is being placed on early interventions for high BP, particularly in those who are low cardiovascular risk(systolic BP 110-139 and diastolic BP < 90 mm Hg), for participants lifestyle modification is recommended. Although lifestyle modifications are effective to lower BP, implementation is suboptimal in Black communities, especially those participants residing in low-income urban settings. Pervasive negative social determinants of health (SDoH), such as poor access to healthcare, food insecurity, limited availability of healthy foods, lack of safe places to engage in physical activity, and low health literacy are major drivers of inequities in HTN and a critical barrier to implementation of recommended lifestyle modifications in Black communities. To achieve health equity, effective strategies must address negative SDoH that are root causes of racial disparities in health outcomes as clearly demonstrated by the coronavirus disease (COVID-19) pandemic. Predominantly Black cities like Detroit, Michigan, where the mortality rate from heart disease is nearly twice the national average, have been devastated by COVID-19. To address this, the investigators developed an innovative mobile health unit (MHU) program that uses geospatial health and social vulnerability data to direct deployment of testing and vaccination services to communities with highest needs. Since April 2020, the investigators conducted 500 events with 220 community partners where 40,000 people have been tested or vaccinated for COVID in MHUs.

Using a hybrid type I effectiveness-implementation design in the proposed Linkage, Empowerment, and Access to Prevent Hypertension (LEAP-HTN) study, the investigators will implement a novel approach that links low cardiovascular risk Black adult participants without stage-2 hypertension to collaborative care delivered in deprived neighborhoods by community health workers (CHWs) using a personalized, adaptable approach to lifestyle and life circumstance (PAL2) intervention. The investigators will leverage our MHU program, layering on top of existing services to streamline access for screening, recruitment and all ongoing follow-up throughout the study period. Our specific aims are:

AIM 1: To compare the effect of PAL2 intervention versus usual care (MHU engagement without PAL2) on systolic BP reduction and prevention of stage 2 HTN (systolic BP ≥ 140 mm Hg and/or diastolic BP >90 mm Hg) among 500 Black adults with baseline untreated systolic BPs below stage 2 (ranging 110-139 mm Hg) and a diastolic BP < 90 mm Hg.

Hypothesis (H) 1a: Systolic BP (primary outcome) will be reduced more in those randomized to PAL2 intervention versus usual care at 6 and 12 months.

H1b: Diastolic BP levels and the incidence of stage 2 HTN (systolic BP ≥ 140 mm Hg and/or diastolic BP >90 mmm Hg) at 6 and 12 months (secondary outcomes) will be lower in participants randomized to the PAL2 intervention versus usual care.

AIM 2: To use the RE-AIM framework to assess the reach, adoption, effectiveness, sustainability and cost of LEAP-HTN at 12 months post-randomization.

H2a: The rates of adoption and sustainability of the PAL2 intervention will increase from baseline to 12 and up to 24 months in subjects with available data, respectively.

H2b: PAL2 intervention will be more cost-effective than usual care at 12 months and projected to be more cost-effective at 10 years.

Health Equity Impact: Targeted deployment of MHUs and PAL2 can mitigate several key adverse SDoH. LEAP-HTN contributes to the RESTORE Network by testing a sustainable and scalable approach to advance health equity and prevent HTN in Black adults participants. If successful, the use of MHU can be easily implemented in similar urban Black communities across the U.S.

Conditions

Hypertension; Blood Pressure; Cardiovascular Disease Other

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Randomized selection of recruited participants that will receive intervention

Group Type: EXPERIMENTAL

PAL2

Intervention Type: 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

Control

Randomized selection of recruited participants that will not receive intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PAL2

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Pragmatic personalized, adaptable approach to lifestyle and life circumstance

Eligibility Criteria

Inclusion Criteria

1. Self-identification as Black, age ≥18 years, living in the Detroit-area

2. Systolic BP 110-139 and diastolic BP <90 mm Hg upon screening

3. Not currently taking medications for HTN

4. Low cardiovascular risk as defined by 2017 AHA/ACC HTN guidelines (no diabetes, no chronic kidney disease, no established ASCVD

5. 10-year ASCVD risk <10% if systolic BP is in stage-1 hypertension range (130-139 mm Hg and < 65 years old

Exclusion Criteria

1. Any clinical cardiovascular disease (e.g., coronary artery disease, heart failure, stroke, arrhythmia)

2. Chronic kidney disease or glomerular filtration rate <60 ml/min on screening laboratory testing

3. Diabetes or HbA1c ≥ 6.5% on screening laboratory testing

4. LDL-C ≥ 190 mg/dL on screening laboratory testing (on or off medications)

5. ASCVD risk score calculated ≥ 10% for 10 years by clinical calculator on screening (if stage-1 systolic HTN only)2

6. Inability or not willing to follow-up with PAL2 research or usual care limb and at 6 & 12-months at the MHU

7. Taking any medications for diabetes, heart disease or kidney disease. Cholesterol medication is not an exclusion

8. Inability to understand and sign informed consent

10. Chronic condition (e.g., cancer) with a potential life expectancy < 2 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Phillip Levy

Professor, Assistant Vice President for Translational Sciences and Clinical Research Innovation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wayne Health Mobile Units

Detroit, Michigan, United States

Countries

United States

Other Identifiers

878605

Identifier Type: -

Identifier Source: org_study_id