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Clinical Trials/NCT03923790
NCT03923790
Completed
Not Applicable

Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction

The University of Texas Health Science Center, Houston1 site in 1 country83 target enrollmentMarch 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke Prevention
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
83
Locations
1
Primary Endpoint
Daytime Ambulatory Systolic Blood Pressure
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this pilot trial is to compare post-stroke care blood pressure (BP) treatment using an interdisciplinary telehealth model [called the Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction] to usual care in stroke patients at risk for uncontrolled BP. The intervention will address general and stroke-related factors associated with racial disparities in BP control. We will assess feasibility of implementation of the trial and will use the measures and outcomes assessed in the pilot to examine knowledge gaps.

Registry
clinicaltrials.gov
Start Date
March 4, 2019
End Date
October 14, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anjail Z Sharrief

Assistant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • Ischemic and hemorrhagic stroke patients
  • Presence of at least one of the following high risk criteria: uninsured, Medicaid payer status, small vessel ischemic stroke, hypertensive ICH)
  • Age ≥ 18; presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
  • Plan to discharge home after stroke
  • Ability to provide consent (patient or caregiver)
  • Ability to communicate in English

Exclusion Criteria

  • modified Rankin scale \> 4 at the time of enrollment (severe disability)
  • life expectancy \< 1 year or terminal illness,
  • eGFR \< 30 at time of discharge
  • pregnancy
  • symptomatic flow limiting carotid stenosis without plan for intervention
  • urine toxicology positive for cocaine or methamphetamine or recent use
  • long-term BP goal ≥ 130/80 mmHg according to clinical team

Outcomes

Primary Outcomes

Daytime Ambulatory Systolic Blood Pressure

Time Frame: 6 months after enrollment

Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).

Secondary Outcomes

  • Nighttime Diastolic Blood Pressure(6 months)
  • Body Mass Index(BMI)(6 months)
  • Night Time Ambulatory Systolic Blood Pressure(6 months)
  • Daytime Ambulatory Diastolic Blood Pressure(6 months)
  • Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)(6 months)
  • Number of Participants With Acute Healthcare Utilization(6 months)

Study Sites (1)

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