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 — BEHAVIORALPrompted SMBP with tailored feedback
- Physician appointment and transportation scheduling — BEHAVIORALPhysician 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 GroupThe 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 OUTREACH 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
- Lesli Skolarus, MD, MS312-503-0644
- William Meurer, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hurley Medical Center | Flint | Michigan | 48503 | Rockefeller Oteng, MD |
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