Video-based Intervention to Address Disparities in Blood Pressure Control After Stroke
- Conditions
- Stroke
- Interventions
- Other: Standard careOther: VIRTUAL
- Registration Number
- NCT05264298
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 534
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care 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. VIRTUAL Intervention (Treatment) VIRTUAL 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.
- Primary Outcome Measures
Name Time Method 6 month blood pressure control (24-hour ambulatory) 6 months after discharge Proportion of participants with controlled BP according to 24- hour ambulatory BP (\<125/75 mmHg)
- Secondary Outcome Measures
Name Time Method 12 month blood pressure control (24-hour ambulatory) 12 months after discharge Proportion of participants with controlled BP according to 24- hour ambulatory BP (\<125/75 mmHg)
Composite Recurrent Vascular Events 12 months after discharge Number of patients with myocardial infarction, ischemic or hemorrhagic stroke, coronary revascularization, acute cardiac death, and heart failure hospitalization)
Acute healthcare utilization 12 months after hospital discharge Number of hospital readmissions, ED visits, and urgent care visits
Proportion of uninsured who obtain insurance 6 months after hospital discharge Proportion of uninsured patients who obtain insurance
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States