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

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Stroke

Treatments: Other: VIRTUAL; Other: Standard care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05264298

1R01MD016465-01 (U.S. NIH Grant/Contract)

HSC-MS-21-0549

Details and patient eligibility

About

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.

Full 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.

Enrollment: 542 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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542 participants in 2 patient groups

VIRTUAL Intervention (Treatment)

Experimental group

Description:

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.

Treatment:

Other: VIRTUAL

Standard Care

Active Comparator group

Description:

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.

Treatment:

Other: Standard care