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.

Not Applicable

Not yet recruiting

• Conditions: Stroke; Hypertension; Home Blood Pressure Monitoring; Implementation Research

• Registration Number: NCT07091851
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

We 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. We think that using both methods together will make it easier to lower blood pressure after a stroke. We need this study to test these two methods together in people who have had a stroke. We believe this is an important study because having high blood pressure makes having another stroke very likely. Therefore, we want to lower blood pressure in people with strokes to keep their brains as healthy aspossible 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. Our prior studies show that VGVs that incorporate HBPM are feasible and effective in a prospective cohort of primary care patients. Our 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 Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Study Start: 2025-08-01
• Primary Completion: 2028-01-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	three months	mean systolic blood pressure