Stroke Clinical Trial
— VIRTUALOfficial title:
Video-based Intervention to Reduce Treatment and OUtcome Disparities in Adults Living With Stroke or Transient Ischemic Attack (VIRTUAL)
Verified date | April 2024 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 534 |
Est. completion date | March 1, 2026 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 24 hour ambulatory systolic blood pressure | 24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month | |
Other | 24 hour ambulatory systolic blood pressure | 24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month | |
Other | 24 hour ambulatory diastolic blood pressure | 24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month | |
Other | 24 hour ambulatory diastolic blood pressure | 24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month | |
Other | Daytime ambulatory systolic blood pressure | Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month | |
Other | Daytime ambulatory systolic blood pressure | Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month | |
Other | Daytime ambulatory diastolic blood pressure | Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month | |
Other | Daytime ambulatory diastolic blood pressure | Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month | |
Other | Night time ambulatory systolic blood pressure | Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month | |
Other | Night time ambulatory systolic blood pressure | Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month | |
Other | Night time ambulatory diastolic blood pressure | Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 6 month | |
Other | Night time ambulatory diastolic blood pressure | Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor | 12 month | |
Other | Proportion of participants who quit smoking or attempt to quit smoking | Among participants who are tobacco users at time of enrollment | 6 months | |
Other | Proportion of participants who quit smoking or attempt to quit smoking | Among participants who are tobacco users at time of enrollment | 12 months | |
Other | Proportion of participants who quit smoking | Among participants who are tobacco users at time of enrollment | 6 months | |
Other | Proportion of participants who quit smoking | Among participants who are tobacco users at time of enrollment | 12 months | |
Other | Depressive symptoms as assessed by score on the Patient Health Questionnaire 9 | Patient Health Questionnaire 9 total score ranges from 0 to 27 | 6 months | |
Other | Depressive symptoms as assessed by score on the Patient Health Questionnaire 9 | Patient Health Questionnaire 9 total score ranges from 0 to 27 | 12 months | |
Primary | 6 month blood pressure control (24-hour ambulatory) | Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg) | 6 months after discharge | |
Secondary | 12 month blood pressure control (24-hour ambulatory) | Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg) | 12 months after discharge | |
Secondary | Composite Recurrent Vascular Events | Number of patients with myocardial infarction, ischemic or hemorrhagic stroke, coronary revascularization, acute cardiac death, and heart failure hospitalization) | 12 months after discharge | |
Secondary | Proportion of uninsured who obtain insurance | Proportion of uninsured patients who obtain insurance | 3 months after hospital discharge | |
Secondary | Proportion of uninsured who obtain insurance | Proportion of uninsured patients who obtain insurance | 6 months after hospital discharge | |
Secondary | Acute healthcare utilization | Number of hospital readmissions, emergency department (ED) visits, and urgent care visits | 3 months after hospital discharge | |
Secondary | Acute healthcare utilization | Number of hospital readmissions, ED visits, and urgent care visits | 6 months after hospital discharge | |
Secondary | Acute healthcare utilization | Number of hospital readmissions, ED visits, and urgent care visits | 12 months after hospital discharge |
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