HypertensionNCT06391073
Reach Out 2: Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems
A study testing Self-Measured Blood Pressure Monitoring and Physician appointment and transportation scheduling in people with Hypertension, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Self-Measured Blood Pressure Monitoring and Physician appointment and transportation scheduling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2024to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Critical illness
- Unable to read English (<1% at study site)
- Incarcerated
- Pregnant
- Pre-existing condition making 6-month follow-up unlikely
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
William Meurer, MD contact
United States1 site, 1 recruiting
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Rockefeller Oteng, MD
About this study
Official title: Reach Out 2: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems
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.
Read the detailed description
Hypertension is the most important modifiable risk factor for cardiovascular disease. Black Americans have the highest prevalence of hypertension and the lowest rates of blood pressure (BP) control of any racial or ethnic group in the U.S., contributing to cardiovascular disease disparities. Low-income Americans are also disproportionally burdened by hypertension. To achieve health equity, new approaches to hypertension management leveraging safety-net healthcare systems to reach underserved populations are needed.
One approach to addressing the hypertension epidemic is to identify and treat people undiagnosed, untreated, or with undertreated hypertension - people who have fallen through the cracks in the healthcare system. We did this in Reach Out 1 (R01MD011516), a mobile health (mHealth) 8-arm factorial trial of hypertensive patients recruited from a safety-net ED. Overall, systolic BP declined by 9.2 mmHg (95% CI -12.2 to - 6.3) after 6 months, without differences across treatment arms. Reach Out 1 successfully enrolled a hypertensive, medically underserved population into a mHealth intervention. Despite a very large reduction in BP overall, the efficacy of the Reach Out mHealth intervention is uncertain, given the lack of a control group.
Reach Out 2 proposes to test the most promising components of Reach Out 1 in a randomized open, blinded-endpoint (PROBE) controlled trial. Reach Out 2, continues our work with the same safety-net ED and Federally Qualified Health Centers. In Reach Out 2, we will compare usual care, to 6-months of prompted self-monitored blood pressure (SMBP) monitoring with tailored feedback and facilitated primary care appointment and transportation. The usual care group will receive instructions to follow up with a primary care provider after ED discharge. After 6 months, the intervention participants will enter an extended treatment period of long-term SMBP monitoring. To contextualize our findings, we will use our chronic disease agent-based simulation model to estimate the reduction in myocardial infarction, stroke, and dementia if Reach Out 2 were to be implemented in safety-net EDs across the US. The overarching goal of our proposal is to determine whether a low-tech mHealth intervention will reduce BP more than usual care among patients recruited from a safety-net ED and to understand the potential national impact of such an intervention. Because safety-net EDs are anchor institutions that care for large populations of medically underserved hypertensive people, mHealth strategies initiated here have tremendous potential to reduce cardiovascular inequities. To reach this potential, evidence based interventions to reduce BP must be identified (aim 1), long-term engagement evaluated (aim 2), and their impact understood (aim 3).
- Conditions
- Hypertension
- Being tested
- Self-Measured Blood Pressure Monitoring, Physician appointment and transportation scheduling
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Measured Blood Pressure MonitoringBehavioural
Prompted SMBP with tailored feedback
Physician appointment and transportation schedulingBehavioural
Physician appointment and transportation scheduling or none dependent on current BP control
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Self-Measured Blood Pressure Monitoring; Behavioral: Physician appointment and transportation scheduling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
Change in 6-month Systolic Blood Pressure (SBP)
Measured: 6 month
Secondary outcomes (2)
Change in diastolic blood pressure
Change in 6-month Diastolic Blood Pressure (DBP)
Measured: 6 month
BP Control (130/80mmHg)
Proportion of participants with controlled BP at 6-months. BP control is defined as BP less than 130/80 mmHg.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start22 Jul 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Ohio State University
- Responsible party
- Principal investigator, Lesli Skolarus, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391073
- Sponsor's protocol ID
- 1R01MD019124
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data in which direct and indirect identifiers have been removed will be made available through data-sharing website
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reach Out 2: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems
- ClinicalTrials.gov ID
- NCT06391073
- Acronym / sponsor ID
- 1R01MD019124
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, Ohio State University
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypertension is the most important modifiable risk factor for cardiovascular disease. Black Americans have the highest prevalence of hypertension and the lowest rates of blood pressure (BP) control of any racial or ethnic group in the U.S., contributing to cardiovascular disease disparities. Low-income Americans are also disproportionally burdened by hypertension. To achieve health equity, new approaches to hypertension management leveraging safety-net healthcare systems to reach underserved populations are needed.
One approach to addressing the hypertension epidemic is to identify and treat people undiagnosed, untreated, or with undertreated hypertension - people who have fallen through the cracks in the healthcare system. We did this in Reach Out 1 (R01MD011516), a mobile health (mHealth) 8-arm factorial trial of hypertensive patients recruited from a safety-net ED. Overall, systolic BP declined by 9.2 mmHg (95% CI -12.2 to - 6.3) after 6 months, without differences across treatment arms. Reach Out 1 successfully enrolled a hypertensive, medically underserved population into a mHealth intervention. Despite a very large reduction in BP overall, the efficacy of the Reach Out mHealth intervention is uncertain, given the lack of a control group.
Reach Out 2 proposes to test the most promising components of Reach Out 1 in a randomized open, blinded-endpoint (PROBE) controlled trial. Reach Out 2, continues our work with the same safety-net ED and Federally Qualified Health Centers. In Reach Out 2, we will compare usual care, to 6-months of prompted self-monitored blood pressure (SMBP) monitoring with tailored feedback and facilitated primary care appointment and transportation. The usual care group will receive instructions to follow up with a primary care provider after ED discharge. After 6 months, the intervention participants will enter an extended treatment period of long-term SMBP monitoring. To contextualize our findings, we will use our chronic disease agent-based simulation model to estimate the reduction in myocardial infarction, stroke, and dementia if Reach Out 2 were to be implemented in safety-net EDs across the US. The overarching goal of our proposal is to determine whether a low-tech mHealth intervention will reduce BP more than usual care among patients recruited from a safety-net ED and to understand the potential national impact of such an intervention. Because safety-net EDs are anchor institutions that care for large populations of medically underserved hypertensive people, mHealth strategies initiated here have tremendous potential to reduce cardiovascular inequities. To reach this potential, evidence based interventions to reduce BP must be identified (aim 1), long-term engagement evaluated (aim 2), and their impact understood (aim 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Self-Measured Blood Pressure Monitoring, Behavioral: Physician appointment and transportation schedulingREACH 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). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Critical illness
- Unable to read English (<1% at study site)
- Incarcerated
- Pregnant
- Pre-existing condition making 6-month follow-up unlikely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Measured Blood Pressure MonitoringPrompted SMBP with tailored feedback | Behavioural | REACH OUT |
| Physician appointment and transportation schedulingPhysician appointment and transportation scheduling or none dependent on current BP control | Behavioural | REACH OUT |
Primary outcome
Change in systolic blood pressure
Time frame: 6 month
Change in 6-month Systolic Blood Pressure (SBP)
2 secondary outcomes
Change in diastolic blood pressure
Time frame: 6 month
BP Control (130/80mmHg)
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. Data in which direct and indirect identifiers have been removed will be made available through data-sharing website
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Meurer, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Measured Blood Pressure Monitoring and Physician appointment and transportation scheduling in people with Hypertension, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lesli Skolarus, MD, MS (312-503-0644, lesli.skolarus@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.