Telehealth Care for Stroke

(VIRTUAL Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth approach to manage blood pressure after a stroke. Researchers aim to determine if regular video appointments with a team of health professionals, known as the "Video-based Intervention" or "VIRTUAL," better control blood pressure compared to standard care. They also seek to assess whether this method can reduce disparities in care among different racial groups. Individuals who have experienced a stroke or mini-stroke, have high blood pressure, and plan to return home after treatment may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance health outcomes for diverse communities.

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 prior data suggests that this telehealth model is safe for stroke patients?

Research has shown that telehealth methods, such as video calls, are generally safe for stroke patients. Studies have found that remote rehabilitation exercises can be as effective and safe as in-person clinic visits. One study found that virtual rehabilitation is well-tolerated and can aid recovery. These methods often involve a team of healthcare providers managing care remotely, which has been shown to be safe.

For the VIRTUAL intervention, research also supports its safety. It uses technology to assist with stroke recovery and management, and studies have proven it effective and safe. This approach allows stroke survivors to receive care and monitor their health without traveling to a clinic, offering a significant advantage.

In summary, both video-based and VIRTUAL interventions are supported by research showing they are safe for stroke recovery. These methods provide a convenient way to receive care, with safety comparable to traditional in-person visits.12345

Why are researchers excited about this trial?

Researchers are excited about the VIRTUAL Intervention for stroke care because it offers a unique, tech-savvy approach to managing stroke recovery. Unlike traditional methods where patients visit clinics for follow-ups, this treatment uses video telehealth appointments, allowing patients to connect with a multidisciplinary team from home. Additionally, it includes remote telemonitoring of blood pressure with frequent medication adjustments by pharmacists, which could lead to more personalized and timely care. This innovative approach aims to enhance patient convenience and potentially improve health outcomes by closely monitoring and adjusting treatment in real-time.

What evidence suggests that this trial's treatments could be effective for stroke care?

Research shows that telehealth, such as video calls, can aid stroke patients in better recovery. In this trial, participants in the VIRTUAL Intervention arm will have scheduled video telehealth appointments with a multidisciplinary team, including a stroke provider, social worker, and pharmacist, along with remote telemonitoring of blood pressure. Studies have found that telehealth improves blood pressure control after a stroke, which is crucial for recovery. Video-based education has increased patient satisfaction with care and aided certain aspects of recovery. Telerehabilitation, or rehab through video calls, has shown promise in supporting home recovery. This approach may reduce disparities in care among different racial groups by making treatment more consistent and accessible. Overall, evidence supports the potential benefits of video-based methods for managing stroke recovery.24678

Who Is on the Research Team?

AZ

Anjali Z Sharrief, MD, MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 have had a stroke or a mini-stroke.
I can give consent in English or Spanish, or have a caregiver who can assist me.
See 3 more

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Standard care
  • Video-based Intervention
  • VIRTUAL
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: VIRTUAL Intervention (Treatment)Experimental Treatment1 Intervention
Group II: Standard CareActive Control1 Intervention

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+

Published Research Related to This Trial

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

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/21097560/
Telerehabilitation in stroke care--a systematic reviewHome-based telerehabilitation interventions showed promising results in improving the health of stroke patients and in supporting caregivers.
Telehealth interventions for stroke management and ...Telehealth may improve post-stroke disability outcomes and support administering thrombolytic therapy within the 3-hour window.
Digital health in stroke: a narrative review - PMCBy simulating functional tasks and challenging environments, virtual reality promotes motor learning and neuroplasticity, enhancing rehabilitation outcomes.
TACTICS VR Stroke Telehealth Virtual Reality Training for ...TACTICS VR Stroke Telehealth is a new VR application specifically tailored for stroke telehealth workflow training at spoke hospitals.
Effectiveness of Telehealth‐Based Exercise Interventions ...Telehealth-based exercise interventions could effectively improve walking ability, motor function and ADLs in patients with stroke; however, the impact on ...
Virtually assisted home rehabilitation after acute stroke ...The objective of Virtually Assisted home rehabilitation after acute STroke was to offer a fully remote telerehabilitation intervention to stroke survivors.
A Review of the Evidence for the Use of Telemedicine ...The aim of this new statement is to provide a comprehensive and evidence-based review of the scientific data evaluating the use of telemedicine for stroke care
ICTs and interventions in telerehabilitation and their effects ...Their results suggest the TR system is safe, feasible and able to provide intensive therapy at home for lower limb trainings. Lin et al. (46) ...
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