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

NCT06593496 | Recruiting

• 1 other identifier: Project-5757
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Hypertension; High Blood Pressure

Keywords

Epidemiology; Mobile Health Unit; Prospective

Outcome Measures

Primary Outcomes (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.

  12 Months

Study Arms (2)

Text Message

EXPERIMENTAL

Participants assigned to the interventional group will receive a text message reminding them to take their blood pressure.

Behavioral: Text Message Reminder

Control/No Text Message

NO INTERVENTION

Those assigned to the usual care group will not receive a reminder text message.

Interventions

Text Message Reminder BEHAVIORAL

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

Text Message

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• + years old
• Consent to allow prospective follow-up including through EHR review

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne Health Mobile Units

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Steven J Korzeniewski, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillip Levy, MD, MPH

CONTACT

313-577-1214; plevy@med.wayne.edu

Katee Dawood, MBA

CONTACT

313-577-1232; kdawood@wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Assistant Vice President for Translational Sciences and Clinical Research Innovation

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: September 19, 2024
• Study Start: June 11, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)