Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

Not Applicable

Completed

• Conditions: Telemedicine; Stroke Prevention; Blood Pressure; Psychosocial Impairment

• Registration Number: NCT03923790
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-04
• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-23
• Primary Completion: 2021-10-14
• Study Completion: 2021-10-14
• Status Verified: 2022-10
• Results First Submitted: 2022-10-14
• Results First Submitted QC: 2022-10-14
• Last Update Submitted: 2022-10-14
• Results First Posted: 2022-11-09
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Daytime Ambulatory Systolic Blood Pressure	6 months after enrollment	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).

Secondary Outcome Measures

Name	Time	Method
Nighttime Diastolic Blood Pressure	6 months	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Body Mass Index(BMI)	6 months	BMI will be calculated from height and weight.
Night Time Ambulatory Systolic Blood Pressure	6 months	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Daytime Ambulatory Diastolic Blood Pressure	6 months	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)	6 months	Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death.
Number of Participants With Acute Healthcare Utilization	6 months	Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care.

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States