Video-based Intervention to Reduce Treatment and OUtcome Disparities in Adults Living With Stroke or Transient Ischemic Attack (VIRTUAL)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 542
- Locations
- 2
- Primary Endpoint
- 6 month blood pressure control (24-hour ambulatory)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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
- 12 month blood pressure control (24-hour ambulatory)(12 months after discharge)
- Composite Recurrent Vascular Events(12 months after discharge)
- Acute healthcare utilization(12 months after hospital discharge)
- Proportion of uninsured who obtain insurance(6 months after hospital discharge)
Investigators
Anjail Z Sharrief
Associate Professor
The University of Texas Health Science Center, Houston