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

Primary Purpose

Stroke

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VIRTUAL
Standard care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VIRTUAL Intervention (Treatment)

Standard Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

6 month blood pressure control (24-hour ambulatory)
Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg)

Secondary Outcome Measures

12 month blood pressure control (24-hour ambulatory)
Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg)
Composite Recurrent Vascular Events
Number of patients with myocardial infarction, ischemic or hemorrhagic stroke, coronary revascularization, acute cardiac death, and heart failure hospitalization)
Proportion of uninsured who obtain insurance
Proportion of uninsured patients who obtain insurance
Proportion of uninsured who obtain insurance
Proportion of uninsured patients who obtain insurance
Acute healthcare utilization
Number of hospital readmissions, emergency department (ED) visits, and urgent care visits
Acute healthcare utilization
Number of hospital readmissions, ED visits, and urgent care visits
Acute healthcare utilization
Number of hospital readmissions, ED visits, and urgent care visits

Full Information

First Posted
February 6, 2022
Last Updated
March 31, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05264298
Brief Title
Video-based Intervention to Address Disparities in Blood Pressure Control After Stroke
Acronym
VIRTUAL
Official Title
Video-based Intervention to Reduce Treatment and OUtcome Disparities in Adults Living With Stroke or Transient Ischemic Attack (VIRTUAL)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
534 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VIRTUAL Intervention (Treatment)
Arm Type
Experimental
Arm 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.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
VIRTUAL
Intervention Description
At the time of discharge, stroke survivors in the VIRTUAL arm will receive a package containing an iPad and a remote BP monitoring device that allows transmission of BP to the study team.The first telehealth visit will occur 7-14 days after discharge. Patient will be counseled on the importance of BP monitoring, salt reduction, and the importance of diet and exercise for stroke prevention. Medications, side effects and interactions will be reviewed. The social worker will refer the patient to specific resources according to social needs abd patient will be referred to a primary care provider if they do not have one. Subsequent video visits will be 1-month (30 days +/- 7) , 3 months (90 days +/- 14), and 5 months (150 days +/- 14) days after enrollment.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Participants randomized to standard care will receive an educational packet and a blood pressure monitor prior to hospital discharge. They will be contacted by a social worker to determine if they received their medications and appointments. The stroke practitioner will evaluate the patients at 7-14 days and then follow up according to current standard of care. They will be seen over video or in-person, according to their preference and capabilities. The pharmacist will contact patients at 1-month (30 +/- 7 days) days over the telephone to review BP logs and will make recommendations to their primary care provider to adjust BP medications. Subsequent pharmacist calls will occur monthly until 6 months and recommendations for medication adjustments will be communicated to their primary care provider.
Primary Outcome Measure Information:
Title
6 month blood pressure control (24-hour ambulatory)
Description
Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg)
Time Frame
6 months after discharge
Secondary Outcome Measure Information:
Title
12 month blood pressure control (24-hour ambulatory)
Description
Proportion of participants with controlled BP according to 24- hour ambulatory BP (<125/75 mmHg)
Time Frame
12 months after discharge
Title
Composite Recurrent Vascular Events
Description
Number of patients with myocardial infarction, ischemic or hemorrhagic stroke, coronary revascularization, acute cardiac death, and heart failure hospitalization)
Time Frame
12 months after discharge
Title
Proportion of uninsured who obtain insurance
Description
Proportion of uninsured patients who obtain insurance
Time Frame
3 months after hospital discharge
Title
Proportion of uninsured who obtain insurance
Description
Proportion of uninsured patients who obtain insurance
Time Frame
6 months after hospital discharge
Title
Acute healthcare utilization
Description
Number of hospital readmissions, emergency department (ED) visits, and urgent care visits
Time Frame
3 months after hospital discharge
Title
Acute healthcare utilization
Description
Number of hospital readmissions, ED visits, and urgent care visits
Time Frame
6 months after hospital discharge
Title
Acute healthcare utilization
Description
Number of hospital readmissions, ED visits, and urgent care visits
Time Frame
12 months after hospital discharge
Other Pre-specified Outcome Measures:
Title
24 hour ambulatory systolic blood pressure
Description
24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
6 month
Title
24 hour ambulatory systolic blood pressure
Description
24 hour systolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
12 month
Title
24 hour ambulatory diastolic blood pressure
Description
24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
6 month
Title
24 hour ambulatory diastolic blood pressure
Description
24 hour diastolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
12 month
Title
Daytime ambulatory systolic blood pressure
Description
Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
6 month
Title
Daytime ambulatory systolic blood pressure
Description
Daytime systolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
12 month
Title
Daytime ambulatory diastolic blood pressure
Description
Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
6 month
Title
Daytime ambulatory diastolic blood pressure
Description
Daytime diastolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
12 month
Title
Night time ambulatory systolic blood pressure
Description
Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
6 month
Title
Night time ambulatory systolic blood pressure
Description
Night time systolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
12 month
Title
Night time ambulatory diastolic blood pressure
Description
Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
6 month
Title
Night time ambulatory diastolic blood pressure
Description
Night time diastolic blood pressure as assessed by an ambulatory blood pressure monitor
Time Frame
12 month
Title
Proportion of participants who quit smoking or attempt to quit smoking
Description
Among participants who are tobacco users at time of enrollment
Time Frame
6 months
Title
Proportion of participants who quit smoking or attempt to quit smoking
Description
Among participants who are tobacco users at time of enrollment
Time Frame
12 months
Title
Proportion of participants who quit smoking
Description
Among participants who are tobacco users at time of enrollment
Time Frame
6 months
Title
Proportion of participants who quit smoking
Description
Among participants who are tobacco users at time of enrollment
Time Frame
12 months
Title
Depressive symptoms as assessed by score on the Patient Health Questionnaire 9
Description
Patient Health Questionnaire 9 total score ranges from 0 to 27
Time Frame
6 months
Title
Depressive symptoms as assessed by score on the Patient Health Questionnaire 9
Description
Patient Health Questionnaire 9 total score ranges from 0 to 27
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjali Z Sharrief, MD, MPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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