N/A
N=83
Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction
Stroke Prevention · Blood Pressure · Telemedicine · Psychosocial Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03923790 ↗Enrolled (actual)
83
Serious AEs
13.6%
Results posted
Nov 2022
Primary outcome: Primary: Daytime Ambulatory Systolic Blood Pressure — 123.6; 128.3 millimeters of mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Educational Packet (Behavioral); Phone call at 72 hours by discharge nurse navigator (Behavioral); Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge (Behavioral); Educational messages every other week (Behavioral); BP monitoring by QardioARM with periodic transmission of BP data (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daytime Ambulatory Systolic Blood Pressure |
123.6; 128.3 | — |
| SECONDARY Daytime Ambulatory Diastolic Blood Pressure |
75.1; 76.5 | — |
| SECONDARY Night Time Ambulatory Systolic Blood Pressure |
117.3; 119.3 | — |
| SECONDARY Nighttime Diastolic Blood Pressure |
69.4; 68 | — |
| SECONDARY Body Mass Index(BMI) |
33.8; 27.7 | — |
| SECONDARY Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death) |
3; 2 | — |
| SECONDARY Number of Participants With Acute Healthcare Utilization |
2; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT03923790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.