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Telehealth Care for Stroke (VIRTUAL Trial)

N/A

Waitlist Available

Led By Anjali Z Sharrief, MD, MPH

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ischemic stroke, hemorrhagic stroke (intracerebral hemorrhage), or transient ischemic attack (TIA)

Ischemic stroke, hemorrhagic stroke (intracerebral hemorrhage),or transient ischemic attack (TIA

Must not have

Stroke unrelated to vascular risk factors (RFs) (drug use, trauma, vasculitis)

Modified Rankin scale (mRs) > 4 (severe disability) at time of discharge

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new telehealth-based model of outpatient care for stroke patients to see if it can help improve blood pressure control and reduce racial disparities in care.

Who is the study for?

This trial is for individuals who've had a stroke or transient ischemic attack (TIA) and have high blood pressure. They must be able to go home after discharge, give consent in English or Spanish, and can participate with a caregiver's help if they have cognitive issues. It's not for those with severe disability, less than a year to live, pregnant women, certain carotid artery conditions without planned treatment, or strokes caused by non-vascular factors.

What is being tested?

The study is testing a video-based telehealth program against standard care to see if it helps control blood pressure better after a stroke. The goal is also to check if this approach reduces racial disparities in managing post-stroke blood pressure.

What are the potential side effects?

Since the intervention involves non-invasive telehealth services rather than medication or surgery, typical medical side effects are not expected. However, participants may experience technical difficulties or privacy concerns related to virtual healthcare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a stroke or a mini-stroke.

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I have had a stroke or a mini-stroke.

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I have high blood pressure, measured over 140/90 mmHg twice.

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I plan to go home after my stroke treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stroke not caused by common risk factors like drug use or trauma.

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I have severe disability (mRs > 4) at discharge.

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I have a narrowed artery in my neck causing symptoms but no plans for surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6 month blood pressure control (24-hour ambulatory)

Secondary study objectives

12 month blood pressure control (24-hour ambulatory)

Acute healthcare utilization

Composite Recurrent Vascular Events

+1 more

Other study objectives

24 hour ambulatory diastolic blood pressure

24 hour ambulatory systolic blood pressure

Daytime ambulatory diastolic blood pressure

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VIRTUAL Intervention (Treatment)Experimental Treatment1 Intervention

Participants assigned to intervention arm will have scheduled video telehealth appointments with a multidisciplinary team (Stroke provider, social worker, pharmacist) and remote telemonitoring of blood pressure with blood pressure medication adjustments biweekly as needed by pharmacists.

Group II: Standard CareActive Control1 Intervention

Participants assigned to standard care will follow-up with a stroke provider within 2 weeks of discharge and primary care as per usual recommendations. Participants will monitor their blood pressure on their own and pharmacists will contact participants monthly to review blood pressure. Pharmacists will make recommendations for blood pressure medication adjustment to participant primary care provider.

0 / 7Eligibility criteria met