Reach Out 2: Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems

Part of paid clinical trials in Flint, Michigan.

Sponsor
Northwestern University
Study ID
NCT06391073
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Self-Measured Blood Pressure Monitoring — BEHAVIORAL
    Prompted SMBP with tailored feedback
  • Physician appointment and transportation scheduling — BEHAVIORAL
    Physician appointment and transportation scheduling or none dependent on current BP control

Study Details

Emergency department visits provide an opportunity to identify people with undiagnosed, untreated, or uncontrolled high blood pressure. In Reach Out, we will test whether a mobile health intervention yields a greater reduction in blood pressure than usual care among individuals identified with high blood pressure during a safety-net emergency department visit. Subsequently, we will estimate the reduction in heart attack, stroke, and dementia if Reach Out were implemented across all U.S. safety-net emergency departments.

Key Dates

Start date
Jul 22, 2024
Status verified
Jul 2025
Primary completion
Mar 1, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Usual Care Group
    The usual care group is standard of care. They will receive the standard ED discharge materials available as recommended by their ED physician. These materials recommend lifestyle changes, dietary changes, medication as directed, and follow-up with a PCP as directed.
  • Experimental: REACH OUT
    REACH OUT messaging is based on BP control. Control is defined as SMBP \<135/85. Every 4 weeks SMBP measurements will be assessed and mHealth components will be escalated, de-escalated, or remain the same. If BP is controlled, SMBP prompts will be sent once a week and there will be no facilitated appointments. If BP is uncontrolled, SMBP prompts will be sent three times per week and facilitated provider scheduling and transportation will occur. Participants will have the option include a partner, friend, or family member with text-messaging capability who could support them on their BP journey. The partner will receive Reach Out materials and text messages to remind the participant to engage in SMBP and of their upcoming appointments (if uncontrolled).

Primary Outcome Measure

Change in systolic blood pressure [ Time Frame: 6 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hurley Medical CenterFlintMichigan48503
Rockefeller Oteng, MD

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