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Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

534 Participants Needed

Telehealth Care for Stroke
(VIRTUAL Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Severe disability, Terminal illness, Pregnancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the impact of a multidisciplinary telehealth-based model of outpatient stroke care on blood pressure control following stroke, and further, to evaluate its impact on racial disparities in post-stroke blood pressure control.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment VIRTUAL for stroke?

Research shows that telemedicine, which includes video-based interventions like VIRTUAL, can effectively provide stroke care by reducing treatment times and increasing the use of important therapies, such as tissue plasminogen activator, at remote hospitals. This approach is as reliable as traditional face-to-face care and helps deliver timely treatment to more patients.¹ ² ³ ⁴ ⁵

Is telehealth care for stroke generally safe for humans?

Research on telehealth for stroke care, including telestroke systems, suggests it is generally safe for humans. Studies have shown that telemedicine can effectively support acute stroke management, providing timely and reliable care, especially in areas with limited access to specialists.⁶ ⁷ ⁸ ⁹ ¹⁰

How is the VIRTUAL video-based intervention treatment for stroke unique compared to other treatments?

The VIRTUAL video-based intervention for stroke is unique because it uses telehealth technology to provide remote care and support, which can improve access to stroke expertise and treatment, especially in areas with limited medical resources. This approach can help address disparities in stroke care by reaching patients who might not otherwise have access to specialized stroke services.¹ ⁶ ¹¹ ¹² ¹³

Research Team

Anjali Z Sharrief, MD, MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Inclusion Criteria

I have had a stroke or a mini-stroke.

I can give consent in English or Spanish, or have a caregiver who can assist me.

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Exclusion Criteria

You have been told by doctors that you have less than a year to live, or you have a very serious illness.

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

Your blood pressure should be below 130/80 mmHg according to your doctors.

See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multidisciplinary telehealth-based intervention focusing on blood pressure control with video telehealth appointments and remote monitoring

6 months

Biweekly telehealth visits

Follow-up

Participants are monitored for blood pressure control and other health outcomes

12 months

Monthly follow-up

Long-term follow-up

Participants are monitored for long-term outcomes such as recurrent vascular events and healthcare utilization

12 months

Treatment Details

Interventions

Standard care
Video-based Intervention
VIRTUAL

Trial OverviewThe 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.

Participant Groups

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

The JOIN App smartphone system significantly reduced door-to-needle times for acute ischemic stroke treatment, improving from a median of 90 minutes to 63 minutes, which can lead to better patient outcomes.

Decisions made using the JOIN App were highly accurate, with a 100% agreement rate for thrombolysis decisions compared to traditional imaging methods, indicating that remote teleconsultation can effectively support stroke management in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a Smartphone Application in the Evaluation and Treatment of Acute Stroke in a Comprehensive Stroke Center.Martins, SCO., Weiss, G., Almeida, AG., et al.[2020]

Telehealth has rapidly expanded in chronic care management, particularly for stroke survivors, but evidence on its effectiveness in reducing disparities in chronic stroke care is still limited.

Ongoing large randomized trials are exploring telehealth and telemonitoring for blood pressure management in diverse populations, highlighting both the potential benefits and barriers of telehealth in improving stroke outcomes related to social determinants of health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Trials to Address Health Equity in Stroke Survivors.Sharrief, AZ., Guzik, AK., Jones, E., et al.[2023]

Stroke is a leading cause of death and disability, yet many patients do not receive the effective treatment of intravenous tissue plasminogen activator due to barriers like lack of access to specialists, especially in rural areas.

Telemedicine, specifically telestroke systems, has emerged as a promising solution to improve access to acute stroke care, showing safety and efficacy in observational studies, and could expand to enhance overall stroke management beyond just the initial treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on telemedicine to improve stroke treatment.Stewart, SF., Switzer, JA.[2017]