Blood Pressure Clinical Trial
— STOP-StrokeOfficial title:
Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction
Verified date | October 2022 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 83 |
Est. completion date | October 14, 2021 |
Est. primary completion date | October 14, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston | National Center for Advancing Translational Sciences (NCATS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Caregiver Burden as Assessed by the Zarit Caregiver Burden Questionnaire | 6 months | ||
Other | Medication Adherence as Assessed by the Morisky Medication Adherence Scale (MMAS) | 6 months | ||
Other | Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES) | 6 months | ||
Other | Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES) | Baseline | ||
Primary | Daytime Ambulatory Systolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | 6 months after enrollment | |
Secondary | Daytime Ambulatory Diastolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | 6 months | |
Secondary | Night Time Ambulatory Systolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | 6 months | |
Secondary | Nighttime Diastolic Blood Pressure | Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM). | 6 months | |
Secondary | Body Mass Index(BMI) | BMI will be calculated from height and weight. | 6 months | |
Secondary | Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death) | Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death. | 6 months | |
Secondary | Number of Participants With Acute Healthcare Utilization | Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care. | 6 months |
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