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HypertensionNCT06593496

Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region Project 1 - Epidemiology (ACHIEVE P1-EPI)

A study testing Text Message Reminder in people with Hypertension and High Blood Pressure, run by Wayne State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 improve cardiometabolic health in two uniquely comparable cities: Detroit, Michigan, and Cleveland, Ohio. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension, High Blood Pressure
What is being tested?
Text Message Reminder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteUnited States
Study dates
11 Jun 2025to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Mobile Health Unit Patients with blood pressure above normal (≥120 systolic and/or ≥80 mmHg)
  • Has a phone with the ability to receive text messages
  • 18+ years old
  • Consent to allow prospective follow-up including through EHR review

Who cannot join

  • Non-mobile health unit patients
  • MHU patients with systolic BP < 120 mmHg AND diastolic BP < 80 mmHg
  • Pregnant Women
  • Children less than 18 years old
  • Individuals viewed by the investigative team as unable to understand and sign the informed consent form
  • Currently enrolled in another on-going interventional trial initiated on the mobile health unit

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Phillip Levy, MD, MPH contact

313-577-1214

plevy@med.wayne.edu

Katee Dawood, MBA contact

313-577-1232

kdawood@wayne.edu

United States1 site, 1 recruiting
  • Wayne Health Mobile Units

    Detroit, Michigan, 48201

    Laura Schulz, lschulz@med.wayne.edu

    Bethany Foster, MPH, bfoste@med.wayne.edu

    Recruiting

Other trials in United States

About this study

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 improve cardiometabolic health in two uniquely comparable cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center involves separate but related projects that aim to improve cardiometabolic health outcomes through better risk factor control for three chronic conditions that are of tremendous public health importance, (hypertension (HTN), heart failure, and coronary heart disease), all of which contribute significantly to premature death in Detroit and Cleveland.

The present study is the prospective observational cohort component of ACHIEVE P1- EPI (Project 1) of the ACHIEVE GREATER Center and serves to characterize the population of patients with blood pressure (BP) levels above normal attending The Wayne Health Mobile Health Unit (MHU) events to better understand key factors (e.g., social determinants of health) that convey information about baseline BP levels and related clinical outcomes (e.g., follow-up clinic visits, BP control, and cardiovascular events).

Read the detailed description

ACHIEVE P1- EPI aligns with the over-arching theme of the ACHIEVE GREATER center to reduce the burden of chronic cardiovascular disease in the urban Great Lakes region. It focuses on understanding key factors that drive the high prevalence and poor control of hypertension (HTN) in communities across metro Detroit. Much of this risk traces to social vulnerability and pervasive negative social determinants of health (SDoH) which impact access and quality of care. ACHIEVE P1- EPI is comprised of two main components: 1) a retrospective analysis of all MHU patients starting in April 2020 (IRB-23-04-5726); and 2) development of a prospective observational sub-cohort of MHU patients that consent to on-going follow up of their health care utilization and outcomes, a subset of whom will also consent to receive a home BP monitor where utilization of the device will be monitored.

This project focuses on the prospective component (ACHIEVE P1- EPI: Prospective), to enable the study team to characterize critical risk factors and track associations with subsequent health outcomes to inform a comprehensive preventative strategy to lower blood pressure (BP) and improve the control of early-stage HTN in the Detroit area.

ACHIEVE P1- EPI proposes an epidemiological approach to characterize key factors that convey information about baseline BP levels and/or that drive subsequent health outcomes. Using a combination of retrospective and prospective observational analytical approaches, the study team will leverage the Wayne Health Mobile Health Unit (MHU) platform to implement an observational cohort study that will characterize the antecedents, correlates and sequelae of abnormal blood pressure. The investigator and study team will also perform a nested randomized trial to determine if text message prompts improve the amount or quality of data collected remotely.

Key issues requiring elucidation are: the prevalence and predictors of negative SDoH among patients as well as their associations with screening BP levels and trajectories; the role of SDoH (and other factors) in determining the progression/remission of high BP over the following year; the rates and predictors of successful linkages with follow-up medical visits and receiving social services; the rates and predictors of the initiation of BP-lowering medications in subsequent clinical care; the persistence and predictors of follow-up clinical visits and treatments; the barriers and facilitators of linkages into the healthcare system; and the ultimate success rates and predictors of reaching BP goals. Answers to these questions will provide invaluable information to help guide data-driven improvements to the MHU program moving forward and inform future scalability in other regions and locations. These results will assist us in the optimizing and up-scaling of the program, including the development of improved strategies to successfully link individuals to social services and follow-up healthcare. The findings will help enhance the study team's overall care delivery pathways with the goals of improved BP control and reduced cardiometabolic health inequities in Detroit and beyond.

The specific aims are:

AIM-1: To develop a prospective observational cohort to observe subsequent health outcomes (e.g., blood pressure levels, cardiometabolic risk factors, clinic visits, medications, cardiovascular events) following MHU participation using Wayne health EMR dataset for follow-up. The study team will assess baseline predictors (e.g., SDoH, medications, demographics) of subsequent health outcomes and plan to probe area- and person-level profiles as potential sources of variation in appropriately developed multilevel models.

AIM-2: To develop a nested randomized trial of a sub-cohort to test for differences in adherence to a blood pressure measurement protocol among an intervention group that receives text message reminders and controls who instead receive standard of care without text message reminders. We will also test for differences in blood pressure profiles and, secondarily, emergency department utilization at 12-month follow-up.

Being tested
Text Message Reminder
Keywords
Epidemiology, Mobile Health Unit, Prospective
Medical subject headings
Hypertension

What participants receive

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

  • Text Message ReminderBehavioural

    Randomized selection of recruited participants that will receive text messages reminding them to take their blood pressure.

Study groups in NCT06593496
Study groupRoleWhat they receive
Text MessageExperimentalParticipants assigned to the interventional group will receive a text message reminding them to take their blood pressure.
Receives: Behavioral: Text Message Reminder
Control/No Text MessageNo interventionThose assigned to the usual care group will not receive a reminder text message.

What is being measured

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

  1. Measure Blood Pressure Protocol Fidelity

    Achieve a minimum of six (6) measurements of two (2) or more readings of systolic and diastolic blood pressures at baseline, Month 6 and Month 11 within a seven (7) day period.

    Measured: 12 Months

Timeline

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

  1. First posted19 Sep 2024
  2. Study start11 Jun 2025
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06593496
Sponsor's protocol ID
Project-5757
Status last verified
Jul 2025
First submitted
30 Jul 2024
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Text Message Reminder in people with Hypertension and High Blood Pressure, 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Jul 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Phillip Levy, MD, MPH (313-577-1214, plevy@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure Blood Pressure Protocol Fidelity (time frame: 12 Months). 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 15 Jul 2025.

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