NCT06391073

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
31mo left

Started Jul 2024

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jul 2024Nov 2028

First Submitted

Initial submission to the registry

April 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

April 25, 2024

Last Update Submit

July 21, 2025

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in systolic blood pressure

    Change in 6-month Systolic Blood Pressure (SBP)

    6 month

Secondary Outcomes (2)

  • Change in diastolic blood pressure

    6 month

  • BP Control (130/80mmHg)

    6 month

Other Outcomes (5)

  • BP Control (140/90mmHg)

    6 month

  • Initiation of antihypertensive medication

    6 month

  • Change in antihypertensive medication

    6 month

  • +2 more other outcomes

Study Arms (2)

Usual Care Group

NO INTERVENTION

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.

REACH OUT

EXPERIMENTAL

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).

Behavioral: Self-Measured Blood Pressure MonitoringBehavioral: Physician appointment and transportation scheduling

Interventions

Self-Measured Blood Pressure MonitoringBEHAVIORAL

Prompted SMBP with tailored feedback

REACH OUT
Physician appointment and transportation schedulingBEHAVIORAL

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

REACH OUT

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hurley Medical Center

Flint, Michigan, 48503, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Lesli Skolarus, MD, MS

CONTACT

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

William Meurer, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 30, 2024

Study Start

July 22, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Data in which direct and indirect identifiers have been removed will be made available through data-sharing website

Shared Documents
STUDY PROTOCOL
Time Frame
Before completion of trial data collection.

Locations

US(1)