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HypertensionNCT05295758

Project 1: ACHIEVE- HTN

A study testing PAL2 in people with Hypertension and Undiagnosed Diseases, run by Wayne State University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 95 yearsHealthy volunteers can take part
Conditions the study is for
Hypertension, Undiagnosed Diseases
What is being tested?
PAL2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
18 Nov 2022to 25 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
  • 10-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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wayne State

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region

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

Read the detailed description

Hypertension (HTN) is the leading risk factor for global morbidity and mortality, accounting for a significant proportion of atherosclerotic cardiovascular disease (CVD), heart failure and chronic kidney disease. Even mild elevations in blood pressure (BP) are harmful whereby individuals with stage 1 HTN (130-139/80-89 mm Hg) are already at double CVD risk. Accordingly, the latest HTN guidelines advocated for earlier treatment to reduce the health consequences and prevent the progression to more severe stages which further increases CVD risk. While nearly half of all Americans have HTN, Black adults suffer from a higher prevalence, worse control rates, and more frequent adverse health effects. They are also at heightened risk for an earlier and accelerated progression from mild to more severe HTN. Unfortunately, little progress has been made over past decades in mitigating health inequities related to high BP. In fact, predominantly Black cities such as Detroit disproportionately suffer from nearly twice the national average mortality rate due to CVD.

Mounting evidence shows that pervasive negative social determinants of heath (SDoH) are major drivers of these inequities and represent a critical barrier to achieving BP control in Black hypertensives. Core issues include poor access to healthcare and a burdensome system for care linkage especially in under-resourced settings, low health education and literacy, and structural inadequacies in care delivery including a failure to address the spectrum of life circumstances that elevate BP and hinder the adoption of salutary lifestyle changes. These systemic issues must be addressed, and remedied early in the hypertension disease process, if the health burden and CVD sequela of high BP are to be successfully reduced in Black communities. To address parallel racial inequities related to COVID-19 in Detroit, we developed an innovative mobile health unit (MHU) program that uses geospatial health and social vulnerability data to target deployment of specially outfitted vehicles to predominately Black communities with the highest needs. Since April 2020, Wayne Health Mobile Unit conducted 550 events with 220 community partners where 45,000 people have been vaccinated or tested for COVID.

In PROJECT 1 (ACHIEVE HTN), of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early Prevention in the Great Lakes Region) research center, the project proposes an innovative approach to identify and control HTN at its earliest stages in undiagnosed Black adults, potentially yielding an enormous benefit towards lifetime health equity. Using a hybrid type I effectiveness-implementation and quasi-experimental design, we will leverage our MHU platform to implement a program that links low CVD risk Black adults with stage 1 HTN to collaborative care delivered by non-physicians, community health workers (CHWs) and pharmacists, consisting of a personalized, adaptable approach to lifestyle and life circumstance (PAL2) intervention for 12-months. Core features of PAL2 include the ability to choose from a menu of readily available interventions that address individual negative SDoH, culturally sensitive health and lifestyle education, and adaptability over time according to its acceptance, effectiveness (reduction in home BP), and evolving patient needs. If BP remains ≥130/80 mm Hg after 6 months, a pharmacist-directed medical treatment algorithm will be added to PAL2 to achieve timely BP control. Program benefits, including BP-lowering, will be assessed during implementation (12-months) and maintenance phases (year 2) after linkage to medical care.

Being tested
PAL2
Keywords
Health Disparities, African American, Prevention
Medical subject headings
Hypertension, Undiagnosed Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PAL2Behavioural

    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

Study groups in NCT05295758
Study groupRoleWhat they receive
PAL2 InterventionExperimentalOverall study cohort will be enrolled into non-randomized active treatment
Receives: Behavioral: PAL2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 months

  2. Blood pressure control rate

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

    Measured: 12 months

Secondary outcomes (4)
  1. BP control without medication use

    1. Effectiveness of the PAL2 intervention will be assessed by the percentage of participants who achieve BP control (<130/80 mm Hg) by lifestyle and PAL2 intervention alone without requiring medication.

    Measured: 12 Months

  2. Population reach

    Reach will be assessed by evaluating the number of patients who are screened by the MHUs; the number and percentage of screened patients who meet inclusion and exclusion criteria for ACHIEVE HTN; the number and percentage of patients who meet inclusion that enroll; and the number and percentage of enrolled patients who do and do not complete the study. For each of these measures, qualitative and quantitative methods will be utilized to understand how patient and community level characteristics may have contributed to higher or lower indicators of reach.

    Measured: 12 months

  3. Durability of BP control over 2 years

    Durability will be evaluated by the change in systolic BP from 12 months to 24 months.

    Measured: 24 months

  4. Home diastolic BP

    Effect of PAL2 on diastolic BP will be evaluated by the change in diastolic BP from baseline to 12 months.

    Measured: 12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start18 Nov 2022
  3. Primary completion25 Jan 2024
  4. Study completion25 Jan 2024

Why it stopped: Due lack of eligible participants

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295758
Sponsor's protocol ID
IRB-22-01-4343
Status last verified
Jun 2024
First submitted
8 Mar 2022
Last updated
10 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PAL2 in people with Hypertension and Undiagnosed Diseases, run by Wayne State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due lack of eligible participants). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Home systolic blood pressure (BP) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.

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