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

Stroke Clinical Trial

— VIRTUAL  

Official title:

Video-based Intervention to Reduce Treatment and OUtcome Disparities in Adults Living With Stroke or Transient Ischemic Attack (VIRTUAL)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05264298
• Other study ID #: HSC-MS-21-0549
• Secondary ID: 1R01MD016465-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• VIRTUAL
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.
• Standard care
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

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