Video-based Intervention to Address Disparities in Blood Pressure Control After Stroke (VIRTUAL)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: VIRTUAL; Other: Standard care

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 Type: Interventional
• Enrollment (Actual): 542
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIRTUAL Intervention (Treatment); 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.	Other: VIRTUAL; 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.
Active Comparator: Standard Care; 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.	Other: Standard care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 month blood pressure control (24-hour ambulatory)	Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg)	6 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 month blood pressure control (24-hour ambulatory)	Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg)	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)	12 months after discharge
Proportion of uninsured who obtain insurance	Proportion of uninsured patients who obtain insurance	3 months after hospital discharge
Proportion of uninsured who obtain insurance	Proportion of uninsured patients who obtain insurance	6 months after hospital discharge
Acute healthcare utilization	Number of hospital readmissions, emergency department (ED) visits, and urgent care visits	3 months after hospital discharge
Acute healthcare utilization	Number of hospital readmissions, ED visits, and urgent care visits	6 months after hospital discharge
Acute healthcare utilization	Number of hospital readmissions, ED visits, and urgent care visits	12 months after hospital discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour ambulatory systolic blood pressure	24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor	6 month
24 hour ambulatory systolic blood pressure	24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor	12 month
24 hour ambulatory diastolic blood pressure	24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor	6 month
24 hour ambulatory diastolic blood pressure	24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor	12 month
Daytime ambulatory systolic blood pressure	Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor	6 month
Daytime ambulatory systolic blood pressure	Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor	12 month
Daytime ambulatory diastolic blood pressure	Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor	6 month
Daytime ambulatory diastolic blood pressure	Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor	12 month
Night time ambulatory systolic blood pressure	Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor	6 month
Night time ambulatory systolic blood pressure	Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor	12 month
Night time ambulatory diastolic blood pressure	Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor	6 month
Night time ambulatory diastolic blood pressure	Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor	12 month
Proportion of participants who quit smoking or attempt to quit smoking	Among participants who are tobacco users at time of enrollment	6 months
Proportion of participants who quit smoking or attempt to quit smoking	Among participants who are tobacco users at time of enrollment	12 months
Proportion of participants who quit smoking	Among participants who are tobacco users at time of enrollment	6 months
Proportion of participants who quit smoking	Among participants who are tobacco users at time of enrollment	12 months
Depressive symptoms as assessed by score on the Patient Health Questionnaire 9	Patient Health Questionnaire 9 total score ranges from 0 to 27	6 months
Depressive symptoms as assessed by score on the Patient Health Questionnaire 9	Patient Health Questionnaire 9 total score ranges from 0 to 27	12 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Anjali Z Sharrief, MD, MPH, The University of Texas Health Science Center, Houston

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): June 29, 2026

Study Registration Dates

• First Submitted: February 6, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: HSC-MS-21-0549; 1R01MD016465-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No