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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05264298
Acronym
VIRTUAL
Enrollment
542
Registered
2022-03-03
Start date
2022-03-29
Completion date
2026-06-29
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief 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.

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.

Interventions

OTHERVIRTUAL

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.

OTHERStandard 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.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
6 month blood pressure control (24-hour ambulatory)6 months after dischargeProportion of participants with controlled BP according to 24- hour ambulatory BP (\<125/75 mmHg)

Secondary

MeasureTime frameDescription
12 month blood pressure control (24-hour ambulatory)12 months after dischargeProportion of participants with controlled BP according to 24- hour ambulatory BP (\<125/75 mmHg)
Composite Recurrent Vascular Events12 months after dischargeNumber of patients with myocardial infarction, ischemic or hemorrhagic stroke, coronary revascularization, acute cardiac death, and heart failure hospitalization)
Proportion of uninsured who obtain insurance3 months after hospital dischargeProportion of uninsured patients who obtain insurance
Acute healthcare utilization3 months after hospital dischargeNumber of hospital readmissions, emergency department (ED) visits, and urgent care visits

Other

MeasureTime frameDescription
Night time ambulatory diastolic blood pressure6 monthNight time diastolic blood pressure as assessed by an ambulatory blood pressure monitor
Proportion of participants who quit smoking or attempt to quit smoking6 monthsAmong participants who are tobacco users at time of enrollment
24 hour ambulatory systolic blood pressure6 month24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor
Depressive symptoms as assessed by score on the Patient Health Questionnaire 96 monthsPatient Health Questionnaire 9 total score ranges from 0 to 27
Proportion of participants who quit smoking6 monthsAmong participants who are tobacco users at time of enrollment
24 hour ambulatory diastolic blood pressure6 month24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor
Daytime ambulatory systolic blood pressure6 monthDaytime systolic blood pressure as assessed by an ambulatory blood pressure monitor
Daytime ambulatory diastolic blood pressure6 monthDaytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor
Night time ambulatory systolic blood pressure6 monthNight time systolic blood pressure as assessed by an ambulatory blood pressure monitor

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026