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BRIDGE: Blood Pressure Reduction and Intervention Delivery Via Group Engagement
NCT07091851 · Massachusetts General Hospital
In plain English
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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.
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-22
Estimated completion: 2028-04-30
Last updated: 2025-09-25
Interventions
Behavioral: Group medical visits and home blood pressure monitoring
Primary outcomes
- • Systolic Blood Pressure (three months)
Sponsor
Massachusetts General Hospital · other
With: American Heart Association
Contacts & investigators
ContactNirupama Yechoor, MD, MSc · contact · nyechoor@mgh.harvard.edu · 857-282-5184
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States