Clinical trial NCT03923790: Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction
Official title: Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Prevention
Blood Pressure
Telemedicine
Psychosocial Impairment
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-04-23
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Daytime Ambulatory Systolic Blood Pressure
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Daytime Ambulatory Diastolic Blood Pressure
timeFrame: 6 months
measure: Night Time Ambulatory Systolic Blood Pressure
timeFrame: 6 months
measure: Nighttime Diastolic Blood Pressure
timeFrame: 6 months
measure: Body Mass Index(BMI)
timeFrame: 6 months
measure: Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)
timeFrame: 6 months
measure: Number of Participants With Acute Healthcare Utilization
timeFrame: 6 months
Other outcomes:
measure: Caregiver Burden as Assessed by the Zarit Caregiver Burden Questionnaire
timeFrame: 6 months
measure: Medication Adherence as Assessed by the Morisky Medication Adherence Scale (MMAS)
timeFrame: 6 months
measure: Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)
timeFrame: 6 months
measure: Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)
timeFrame: Baseline
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University Of Texas Health Science Center of Houston
name: Anjail Sharrief
role: PRINCIPAL_INVESTIGATOR
References: