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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
VIRTUAL Trial 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.Check my eligibility
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.See study design
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.
VIRTUAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 can give consent in English or Spanish, or have a caregiver who can assist me.
Select...
I have high blood pressure, measured over 140/90 mmHg twice.
Select...
I plan to go home after my stroke treatment.
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I plan to go home after my stroke treatment.
Select...
I have high blood pressure, measured over 140/90 mmHg twice.
VIRTUAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6 month blood pressure control (24-hour ambulatory)
Secondary outcome measures
12 month blood pressure control (24-hour ambulatory)
Acute healthcare utilization
Composite Recurrent Vascular Events
+1 moreOther outcome measures
24 hour ambulatory diastolic blood pressure
24 hour ambulatory systolic blood pressure
Daytime ambulatory diastolic blood pressure
+6 moreVIRTUAL 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.
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,587 Total Patients Enrolled
42 Trials studying Stroke
6,873 Patients Enrolled for Stroke
National Institute on Minority Health and Health Disparities (NIMHD)NIH
373 Previous Clinical Trials
1,213,922 Total Patients Enrolled
9 Trials studying Stroke
14,614 Patients Enrolled for Stroke
Anjali Z Sharrief, MD, MPHPrincipal InvestigatorThe University of Texas Health Science Center, Houston
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been told by doctors that you have less than a year to live, or you have a very serious illness.I have had a stroke or a mini-stroke.I have had a stroke or a mini-stroke.I had a stroke not caused by common risk factors like drug use or trauma.I can give consent in English or Spanish, or have a caregiver who can assist me.Your blood pressure should be below 130/80 mmHg according to your doctors.I have high blood pressure, measured over 140/90 mmHg twice.Two brain doctors must both say you have a TIA.I plan to go home after my stroke treatment.Two brain doctors need to confirm that you had a TIA (mini-stroke).I plan to go home after my stroke treatment.I have severe disability (mRs > 4) at discharge.I have a narrowed artery in my neck causing symptoms but no plans for surgery.I have high blood pressure, measured over 140/90 mmHg twice.I or my caregiver can consent in English or Spanish, and I have support if I can't communicate well.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Care
- Group 2: VIRTUAL Intervention (Treatment)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project currently enrolling participants?
"The records on clinicaltrials.gov show that this investigation, which was initially published in March of 2022, is no longer actively looking for volunteers. However, 1043 other studies are still recruiting patients at present."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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