StrokeVIRTUALNCT05264298
Video-based Intervention to Address Disparities in Blood Pressure Control After Stroke
A study testing VIRTUAL in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- VIRTUAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2022to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke, hemorrhagic stroke (intracerebral hemorrhage),or transient ischemic attack (TIA
- Presence of hypertension (by clinical history or hospital BP ≥140/90 mmHg on two occasions)
- Plan to discharge home after stroke
- Ability to provide consent (patient or caregiver) in English or Spanish. Patients with cognitive impairment or aphasia limiting participation will be included if they have a caregiver to assist with monitoring and telehealth visits.
- Two neurologists must agree on TIA diagnosis
Who cannot join
- Modified Rankin scale (mRs) > 4 (severe disability) at time of discharge
- Life expectancy < 1 year or terminal illness
- Stroke unrelated to vascular risk factors (RFs) (drug use, trauma, vasculitis)
- Pregnancy
- Symptomatic flow limiting carotid stenosis without plan for intervention
- Long-term BP goal ≥ 130/80 mmHg according to clinical team
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Video-based Intervention to Reduce Treatment and OUtcome Disparities in Adults Living With Stroke or Transient Ischemic Attack (VIRTUAL)
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.
Read the detailed description
Blood pressure is poorly controlled for many stroke survivors and racial disparities in blood pressure control and stroke recurrence exist.
The purpose of this study is to examine the impact of a multidisciplinary, telehealth based, outpatient model of care on outcomes after stroke with a focus on blood pressure control. The Video-based Intervention to Reduce Treatment and Outcome Disparities in Adults Livings with Stroke and Transient Ischemic Attack (VIRTUAL) has several components including early follow-up via telehealth with a multidisciplinary team, remote blood pressure monitoring, and medication adjustment by a pharmacist.
- Conditions
- Stroke
- Being tested
- VIRTUAL, Standard care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIRTUALOther
At the time of discharge, stroke survivors in the VIRTUAL arm will receive a package containing an iPad and a remote BP monitoring device that allows transmission of BP to the study team.The first telehealth visit will occur 7-14 days after discharge. Patient will be counseled on the importance of BP monitoring, salt reduction, and the importance of diet and exercise for stroke prevention. Medications, side effects and interactions will be reviewed. The social worker will refer the patient to specific resources according to social needs abd patient will be referred to a primary care provider if they do not have one. Subsequent video visits will be 1-month (30 days +/- 7) , 3 months (90 days +/- 14), and 5 months (150 days +/- 14) days after enrollment.
Standard careOther
Participants randomized to standard care will receive an educational packet and a blood pressure monitor prior to hospital discharge. They will be contacted by a social worker to determine if they received their medications and appointments. The stroke practitioner will evaluate the patients at 7-14 days and then follow up according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities. The pharmacist will contact patients at 1-month (30 +/- 7 days) days over the telephone to review BP logs and will make recommendations to their primary care provider to adjust BP medications. Subsequent pharmacist calls will occur monthly until 6 months and recommendations for medication adjustments will be communicated to their primary care provider.
| Study group | Role | What they receive |
|---|---|---|
| VIRTUAL Intervention (Treatment) | Experimental | 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. Receives: Other: VIRTUAL |
| Standard Care | Active comparator | 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month blood pressure control (24-hour ambulatory)
Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg)
Measured: 6 months after discharge
Secondary outcomes (7)
12 month blood pressure control (24-hour ambulatory)
Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg)
Measured: 12 months after discharge
Composite Recurrent Vascular Events
Number of patients with myocardial infarction, ischemic or hemorrhagic stroke, coronary revascularization, acute cardiac death, and heart failure hospitalization)
Measured: 12 months after discharge
Proportion of uninsured who obtain insurance
Proportion of uninsured patients who obtain insurance
Measured: 3 months after hospital discharge
Proportion of uninsured who obtain insurance
Proportion of uninsured patients who obtain insurance
Measured: 6 months after hospital discharge
Acute healthcare utilization
Number of hospital readmissions, emergency department (ED) visits, and urgent care visits
Measured: 3 months after hospital discharge
Acute healthcare utilization
Number of hospital readmissions, ED visits, and urgent care visits
Measured: 6 months after hospital discharge
Acute healthcare utilization
Number of hospital readmissions, ED visits, and urgent care visits
Measured: 12 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start29 Mar 2022
- Primary completion29 Jun 2026 (estimated)
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Anjail Z Sharrief, The University of Texas Health Science Center, Houston
- Investigators
- Anjali Z Sharrief, MD, MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264298
- Sponsor's protocol ID
- HSC-MS-21-0549
- Other IDs
- 1R01MD016465-01
- Acronym
- VIRTUAL
- Status last verified
- Jun 2025
- First submitted
- 6 Feb 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okpala M, Izeogu C, Wang M, Green C, Cooksey G, Nguyen T, Cohen S, Bryant L, Hernandez DC, Bernstam EV, Gonzales M, Conyers R, Chiadika O, Varacalli K, Savitz SI, Yamal JM, Sharrief AZ. Video-based Intervention to Reduce Treatment and Outcome Disparities in Adults Living with Stroke or Transient Ischemic Attack (VIRTUAL): protocol for a randomized controlled trial. Trials. 2025 Aug 12;26(1):288. doi: 10.1186/s13063-025-09003-5.
PubMed 40796883
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-based Intervention to Reduce Treatment and OUtcome Disparities in Adults Living With Stroke or Transient Ischemic Attack (VIRTUAL)
- ClinicalTrials.gov ID
- NCT05264298
- Acronym / sponsor ID
- VIRTUAL / HSC-MS-21-0549
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 542 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 29 Jun 2026 (estimated)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Blood pressure is poorly controlled for many stroke survivors and racial disparities in blood pressure control and stroke recurrence exist.
The purpose of this study is to examine the impact of a multidisciplinary, telehealth based, outpatient model of care on outcomes after stroke with a focus on blood pressure control. The Video-based Intervention to Reduce Treatment and Outcome Disparities in Adults Livings with Stroke and Transient Ischemic Attack (VIRTUAL) has several components including early follow-up via telehealth with a multidisciplinary team, remote blood pressure monitoring, and medication adjustment by a pharmacist.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIRTUAL Intervention (Treatment) | Experimental | Other: VIRTUALParticipants 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. |
| Standard Care | Active comparator | Other: Standard careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ischemic stroke, hemorrhagic stroke (intracerebral hemorrhage),or transient ischemic attack (TIA
- Presence of hypertension (by clinical history or hospital BP ≥140/90 mmHg on two occasions)
- Plan to discharge home after stroke
- Ability to provide consent (patient or caregiver) in English or Spanish. Patients with cognitive impairment or aphasia limiting participation will be included if they have a caregiver to assist with monitoring and telehealth visits.
- Two neurologists must agree on TIA diagnosis
Key exclusion criteria (6 listed)
- Modified Rankin scale (mRs) > 4 (severe disability) at time of discharge
- Life expectancy < 1 year or terminal illness
- Stroke unrelated to vascular risk factors (RFs) (drug use, trauma, vasculitis)
- Pregnancy
- Symptomatic flow limiting carotid stenosis without plan for intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIRTUALAt the time of discharge, stroke survivors in the VIRTUAL arm will receive a package containing an iPad and a remote BP monitoring device that allows transmission of BP to the study team.The first telehealth visit will occur 7-14 days after discharge. Patient will be counseled on the importance of BP monitoring, salt reduction, and the importance of diet and exercise for stroke prevention. Medications, side effects and interactions will be reviewed. The social worker will refer the patient to specific resources according to social needs abd patient will be referred to a primary care provider if they do not have one. Subsequent video visits will be 1-month (30 days +/- 7) , 3 months (90 days +/- 14), and 5 months (150 days +/- 14) days after enrollment. | Other | VIRTUAL Intervention (Treatment) |
| Standard careParticipants randomized to standard care will receive an educational packet and a blood pressure monitor prior to hospital discharge. They will be contacted by a social worker to determine if they received their medications and appointments. The stroke practitioner will evaluate the patients at 7-14 days and then follow up according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities. The pharmacist will contact patients at 1-month (30 +/- 7 days) days over the telephone to review BP logs and will make recommendations to their primary care provider to adjust BP medications. Subsequent pharmacist calls will occur monthly until 6 months and recommendations for medication adjustments will be communicated to their primary care provider. | Other | Standard Care |
Primary outcome
6 month blood pressure control (24-hour ambulatory)
Time frame: 6 months after discharge
Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg)
7 secondary outcomes
12 month blood pressure control (24-hour ambulatory)
Time frame: 12 months after discharge
Composite Recurrent Vascular Events
Time frame: 12 months after discharge
Proportion of uninsured who obtain insurance
Time frame: 3 months after hospital discharge
Proportion of uninsured who obtain insurance
Time frame: 6 months after hospital discharge
Acute healthcare utilization
Time frame: 3 months after hospital discharge
Acute healthcare utilization
Time frame: 6 months after hospital discharge
Acute healthcare utilization
Time frame: 12 months after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Derived from this study: PubMed 40796883Okpala M, Izeogu C, Wang M, Green C, Cooksey G, Nguyen T, Cohen S, Bryant L, Hernandez DC, Bernstam EV, Gonzales M, Conyers R, Chiadika O, Varacalli K, Savitz SI, Yamal JM, Sharrief AZ. Video-based Intervention to Reduce Treatment and Outcome Disparities in Adults Living with Stroke or Transient Ischemic Attack (VIRTUAL): protocol for a randomized controlled trial. Trials. 2025 Aug 12;26(1):288. doi: 10.1186/s13063-025-09003-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anjali Z Sharrief, MD, MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIRTUAL in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 month blood pressure control (24-hour ambulatory) (time frame: 6 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05264298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.