Clinical trial NCT05264298: Video-based Intervention to Address Disparities in Blood Pressure Control After Stroke
Official title: Video-based Intervention to Reduce Treatment and OUtcome Disparities in Adults Living With Stroke or Transient Ischemic Attack (VIRTUAL)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-03-03
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6 month blood pressure control (24-hour ambulatory)
timeFrame: 6 months after discharge
Secondary outcomes:
measure: 12 month blood pressure control (24-hour ambulatory)
timeFrame: 12 months after discharge
measure: Composite Recurrent Vascular Events
timeFrame: 12 months after discharge
measure: Proportion of uninsured who obtain insurance
timeFrame: 3 months after hospital discharge
measure: Proportion of uninsured who obtain insurance
timeFrame: 6 months after hospital discharge
measure: Acute healthcare utilization
timeFrame: 3 months after hospital discharge
measure: Acute healthcare utilization
timeFrame: 6 months after hospital discharge
measure: Acute healthcare utilization
timeFrame: 12 months after hospital discharge
Other outcomes:
measure: 24 hour ambulatory systolic blood pressure
timeFrame: 6 month
measure: 24 hour ambulatory systolic blood pressure
timeFrame: 12 month
measure: 24 hour ambulatory diastolic blood pressure
timeFrame: 6 month
measure: 24 hour ambulatory diastolic blood pressure
timeFrame: 12 month
measure: Daytime ambulatory systolic blood pressure
timeFrame: 6 month
measure: Daytime ambulatory systolic blood pressure
timeFrame: 12 month
measure: Daytime ambulatory diastolic blood pressure
timeFrame: 6 month
measure: Daytime ambulatory diastolic blood pressure
timeFrame: 12 month
measure: Night time ambulatory systolic blood pressure
timeFrame: 6 month
measure: Night time ambulatory systolic blood pressure
timeFrame: 12 month
measure: Night time ambulatory diastolic blood pressure
timeFrame: 6 month
measure: Night time ambulatory diastolic blood pressure
timeFrame: 12 month
measure: Proportion of participants who quit smoking or attempt to quit smoking
timeFrame: 6 months
measure: Proportion of participants who quit smoking or attempt to quit smoking
timeFrame: 12 months
measure: Proportion of participants who quit smoking
timeFrame: 6 months
measure: Proportion of participants who quit smoking
timeFrame: 12 months
measure: Depressive symptoms as assessed by score on the Patient Health Questionnaire 9
timeFrame: 6 months
measure: Depressive symptoms as assessed by score on the Patient Health Questionnaire 9
timeFrame: 12 months
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Anjali Z Sharrief, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: