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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Hypertension, Undiagnosed Diseases
- 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 group | Role | What they receive |
|---|---|---|
| PAL2 Intervention | Experimental | Overall 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.
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
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)
BP control without medication use
- 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
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
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
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.
- First posted25 Mar 2022
- Study start18 Nov 2022
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Why it stopped: Due lack of eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert D Brook, Wayne State University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region
- ClinicalTrials.gov ID
- NCT05295758
- Acronym / sponsor ID
- IRB-22-01-4343
- Conditions
- Hypertension, Undiagnosed Diseases
- Keywords
- Health Disparities, African American, Prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due lack of eligible participants
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAL2 Intervention | Experimental | Behavioral: PAL2Overall study cohort will be enrolled into non-randomized active treatment |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Key exclusion criteria (8 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAL2Community 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 | Behavioural | PAL2 Intervention |
Primary outcome
Home systolic blood pressure (BP)
Time frame: 12 months
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).
Blood pressure control rate
Time frame: 12 months
Percentage of study participants who achieve blood pressure control (< 130/80) at 12 months compared to baseline.
4 secondary outcomes
BP control without medication use
Time frame: 12 Months
Population reach
Time frame: 12 months
Durability of BP control over 2 years
Time frame: 24 months
Home diastolic BP
Time frame: 12months
Results and safety
The study was stopped early (reason given: Due lack of eligible participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.