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

NCT05264298 | Active Not Recruiting DMC

• 2 other identifiers: HSC-MS-21-05491R01MD016465-01
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 12 month blood pressure control (24-hour ambulatory)

  12 months after discharge

• Composite Recurrent Vascular Events

  12 months after discharge

• Proportion of uninsured who obtain insurance

  3 months after hospital discharge

• Proportion of uninsured who obtain insurance

  6 months after hospital discharge

• Acute healthcare utilization

  3 months after hospital discharge

Other Outcomes (18)

• 24 hour ambulatory systolic blood pressure

  6 month

• 24 hour ambulatory systolic blood pressure

  12 month

• 24 hour ambulatory diastolic blood pressure

  6 month

Study Arms (2)

VIRTUAL Intervention (Treatment)

EXPERIMENTAL

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.

Other: VIRTUAL

Standard Care

ACTIVE COMPARATOR

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.

Other: Standard care

Interventions

VIRTUAL OTHER

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.

VIRTUAL Intervention (Treatment)

Standard care OTHER

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Okpala M, Izeogu C, Wang M, Green C, Cooksey G, Nguyen T, Cohen S, Bryant L, Hernandez DC, Bernstam EV, Gonzales M, Conyers R, Chiadika O, Varacalli K, Savitz SI, Yamal JM, Sharrief AZ. Video-based Intervention to Reduce Treatment and Outcome Disparities in Adults Living with Stroke or Transient Ischemic Attack (VIRTUAL): protocol for a randomized controlled trial. Trials. 2025 Aug 12;26(1):288. doi: 10.1186/s13063-025-09003-5.

  PMID: 40796883 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anjali Z Sharrief, MD, MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: March 3, 2022
• Study Start: March 29, 2022
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): June 29, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)