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StrokeBRIDGENCT07091851

BRIDGE: Blood Pressure Reduction and Intervention Delivery Via Group Engagement

A study testing Group medical visits and home blood pressure monitoring in people with Stroke and Hypertension, run by Massachusetts General Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The investigators want to improve care for people who have had a stroke. High blood pressure is the leading cause for having a second stroke and can lead to poor brain health. The goal of this study is to compare two new ways of lowering blood pressure. Read more about this study

Who is it for?
Ages 35 years and older
What is being tested?
Group medical visits and home blood pressure monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
22 Sep 2025to 30 Apr 2028
Phase
Interventional

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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Incident, mild to moderate, ischemic or hemorrhagic stroke (NIHSS≤15, ICH score≤3)
  • history or new diagnosis of hypertension
  • ability to read and speak English
  • internet access
  • established primary care physician at MGH

Who cannot join

  • severe stroke (NIHSS>15, ICH score>3)
  • discharge location to inpatient rehabilitation or skilled nursing facility
  • dementia
  • subjects with moderate to severe aphasia without a caregiver to consent on their behalf

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nirupama Yechoor, MD, MSc contact

857-282-5184

nyechoor@mgh.harvard.edu

United States1 site, 1 recruiting
  • Massachusetts General Hospital

    Boston, Massachusetts, 02115

    Nirupama Yechoor, MD, MSC, 8572825184, nyechoor@mgh.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: A Hybrid Type 1 Randomized Trial for Improved Post-Stroke Hypertension: This Study Aims to Examine the Impact of Group Medical Visits and Home Blood Pressure Monitoring Versus Home Blood Pressure Monitoring Alone on the the Impact of Hypertension in Those With Recent Stroke.

The investigators want to improve care for people who have had a stroke. High blood pressure is the leading cause for having a second stroke and can lead to poor brain health. The goal of this study is to compare two new ways of lowering blood pressure. The first way is to help people check their blood pressure at home. The second way is to bring people together and learn about blood pressure in a group setting. The study team thinks that using both methods together will make it easier to lower blood pressure after a stroke. The study team needs this study to test these two methods together in people who have had a stroke. The investigators believe this is an important study because having high blood pressure makes having another stroke very likely. Therefore, the investigators want to lower blood pressure in people with strokes to keep their brains as healthy as possible and to help with stroke recovery.

Read the detailed description

Lowering blood pressure is a clear and effective target for improved secondary stroke prevention. Two evidenced-based interventions have shown clinical effectiveness in non-stroke populations to improve hypertension. Frist, home blood pressure monitoring (HBPM) has been shown to be accurate, pragmatic, effective, and incorporated into AHA guidelines. The second evidence-based intervention is the virtual group visit (VGV) model. VGVs are shared medical appointments conducted over virtual conference rooms that aim to provide pragmatic, patient-centered, cost-effective care for chronic disease management by leveraging patients' shared lived experiences to create a supportive community. The study team's prior studies show that VGVs that incorporate HBPM are feasible and effective in a prospective cohort of primary care patients. The investigators have generated preliminary data also suggest that stroke survivors find serial virtual focus groups feasible and useful. However, no studies to date have tested VGVs that incorporate HBPM in a stroke survivor population. The long-term goal of this proposal is to use implementation science to investigate alternative models of care to promote neuro-recovery and improve secondary stroke prevention. The overall research objective of this proposal is to first adapt existing evidence-based interventions using the CFIR framework, then conduct a Hybrid Type 1 randomized control trial to test effectiveness of a VGV-HBPM intervention compared to HBPM-alone in stroke survivors, and finally to measure the implementation outcomes of adoption and acceptability using the RE-AIM framework. The central hypothesis is that a VGV-HBPM intervention will result in superior BP control at 3-months compared to HBPM-alone in stroke survivors and will have high adoption and acceptability.

The rationale for this proposed research is that two evidence-based interventions show promise to help lower blood pressure and could be adapted for a very high-risk patient population. Guided by proven implementation science frameworks, three aims will be investigated: 1) adapt a VGV-HBPM model for stroke survivors and caregivers; 2) conduct a pilot randomized control trial to test the effectiveness of VGV-HBPM compared to HBPM-alone in stroke survivors; 3) measure the adoption and acceptability of our intervention. Successful completion of this proposal will lead to a refined, implementation-ready intervention and inform a fully powered efficacy trial for future proposals.

Being tested
Group medical visits and home blood pressure monitoring
Keywords
stroke, post-stroke hypertension, implementation science
Medical subject headings
Stroke, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group medical visits and home blood pressure monitoringBehavioural

    This arm will receive instructions for home blood pressure monitoring but also be enrolled in group medical visits.

Study groups in NCT07091851
Study groupRoleWhat they receive
ControlActive comparatorHome blood pressure monitoring alone
Receives: Behavioral: Group medical visits and home blood pressure monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic Blood Pressure

    mean systolic blood pressure

    Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start22 Sep 2025
  3. Primary completion30 Jan 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07091851
Sponsor's protocol ID
2025P001538
Acronym
BRIDGE
Status last verified
Sep 2025
First submitted
21 Jul 2025
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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