Recruiting

Hypertension Intervention

Sponsor:

Northwestern University

Code:

NCT06391073

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Self-Measured Blood Pressure Monitoring

Physician appointment and transportation scheduling

Study Details

Brief summary:

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.

Conditions

Hypertension

Study ID

NCT06391073

Start date

Jul 22, 2024

Status verified date

Jun, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

While in the ED, the patient must meet all of the following:

  • Adult (≥18 y/o)
  • At least one BP with Systolic BP ≥160 or a Diastolic BP ≥100 (criteria 1)
  • If the patient has repeated measurements after achieving Criteria 1, at least one of the repeat BP remains systolic BP ≥140 or a diastolic BP ≥90
  • Must have cell phones with text-messaging capability
  • Likely to be discharged from the ED

Exclusion Criteria for Main Trial Participants:

  • Critical illness
  • Unable to read English (<1% at study site)
  • Incarcerated
  • Pregnant
  • Pre-existing condition making 6-month follow-up unlikely

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Self-Measured Blood Pressure Monitoring

Prompted SMBP with tailored feedback

Physician appointment and transportation scheduling

Physician appointment and transportation scheduling or none dependent on current BP control

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lesli Skolarus, MD, MS

312-503-0644lesli.skolarus@northwestern.edu

Locations

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

More Information

Sponsor

Northwestern University

Last update posted

Jul 13, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-07-13.