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.
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
- Conditions the study is for
- Stroke, Hypertension, Home Blood Pressure Monitoring
- What is being tested?
- Group medical visits and home blood pressure monitoring
- Type of treatment
- Lifestyle or therapy programme
- 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
- 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 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.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02115
Nirupama Yechoor, MD, MSC, 8572825184, nyechoor@mgh.harvard.edu
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 group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Home 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.
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.
- First posted29 Jul 2025
- Study start22 Sep 2025
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Nirupama Yechoor, MD, MSC, Massachusetts General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07091851
- Acronym / sponsor ID
- BRIDGE / 2025P001538
- Keywords
- stroke, post-stroke hypertension, implementation science
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 29 Jul 2025 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Group medical visits and home blood pressure monitoringHome blood pressure monitoring alone |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Group medical visits and home blood pressure monitoringThis arm will receive instructions for home blood pressure monitoring but also be enrolled in group medical visits. | Behavioural | Control |
Primary outcome
Systolic Blood Pressure
Time frame: three months
mean systolic blood pressure
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 25 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 5 inclusion and 4 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 25 Sep 2025. 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 Nirupama Yechoor, MD, MSc (857-282-5184, nyechoor@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: three months). 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 25 Sep 2025.