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NCT Number: NCT05264298

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIRTUAL

Other

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 care

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 12 month blood pressure control (24-hour ambulatory)

    Time frame: 12 months after discharge

    Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg)

  2. Composite Recurrent Vascular Events

    Time frame: 12 months after discharge

    Number of patients with myocardial infarction, ischemic or hemorrhagic stroke, coronary revascularization, acute cardiac death, and heart failure hospitalization)

  3. Proportion of uninsured who obtain insurance

    Time frame: 3 months after hospital discharge

    Proportion of uninsured patients who obtain insurance

  4. Proportion of uninsured who obtain insurance

    Time frame: 6 months after hospital discharge

    Proportion of uninsured patients who obtain insurance

  5. Acute healthcare utilization

    Time frame: 3 months after hospital discharge

    Number of hospital readmissions, emergency department (ED) visits, and urgent care visits

  6. Acute healthcare utilization

    Time frame: 6 months after hospital discharge

    Number of hospital readmissions, ED visits, and urgent care visits

  7. Acute healthcare utilization

    Time frame: 12 months after hospital discharge

    Number of hospital readmissions, ED visits, and urgent care visits

Other outcomes

  1. 24 hour ambulatory systolic blood pressure

    Time frame: 6 month

    24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor

  2. 24 hour ambulatory systolic blood pressure

    Time frame: 12 month

    24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor

  3. 24 hour ambulatory diastolic blood pressure

    Time frame: 6 month

    24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor

  4. 24 hour ambulatory diastolic blood pressure

    Time frame: 12 month

    24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor

  5. Daytime ambulatory systolic blood pressure

    Time frame: 6 month

    Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor

  6. Daytime ambulatory systolic blood pressure

    Time frame: 12 month

    Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor

  7. Daytime ambulatory diastolic blood pressure

    Time frame: 6 month

    Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor

  8. Daytime ambulatory diastolic blood pressure

    Time frame: 12 month

    Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor

  9. Night time ambulatory systolic blood pressure

    Time frame: 6 month

    Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor

  10. Night time ambulatory systolic blood pressure

    Time frame: 12 month

    Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor

  11. Night time ambulatory diastolic blood pressure

    Time frame: 6 month

    Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor

  12. Night time ambulatory diastolic blood pressure

    Time frame: 12 month

    Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor

  13. Proportion of participants who quit smoking or attempt to quit smoking

    Time frame: 6 months

    Among participants who are tobacco users at time of enrollment

  14. Proportion of participants who quit smoking or attempt to quit smoking

    Time frame: 12 months

    Among participants who are tobacco users at time of enrollment

  15. Proportion of participants who quit smoking

    Time frame: 6 months

    Among participants who are tobacco users at time of enrollment

  16. Proportion of participants who quit smoking

    Time frame: 12 months

    Among participants who are tobacco users at time of enrollment

  17. Depressive symptoms as assessed by score on the Patient Health Questionnaire 9

    Time frame: 6 months

    Patient Health Questionnaire 9 total score ranges from 0 to 27

  18. Depressive symptoms as assessed by score on the Patient Health Questionnaire 9

    Time frame: 12 months

    Patient Health Questionnaire 9 total score ranges from 0 to 27

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Video-based Intervention to Reduce Treatment and OUtcome Disparities in Adults Living With Stroke or Transient Ischemic Attack (VIRTUAL)

Acronym: VIRTUAL

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2022
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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