NCT07091851

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
23mo left

Started Sep 2025

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Sep 2025Apr 2028

First Submitted

Initial submission to the registry

July 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

July 21, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

strokepost-stroke hypertensionimplementation science

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    mean systolic blood pressure

    three months

Study Arms (1)

Control

ACTIVE COMPARATOR

Home blood pressure monitoring alone

Behavioral: Group medical visits and home blood pressure monitoring

Interventions

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

Control

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

StrokeHypertension

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Nirupama Yechoor, MD, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Neurology

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 29, 2025

Study Start

September 22, 2025

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations