Connected Health Blood Pressure Monitoring In Stroke and TIA Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/4/2018 |
| Start Date: | November 2015 |
| End Date: | January 2019 |
The goal of this pilot project is to assess adherence with home blood pressure monitoring in
hypertensive patients with a history of cerebral infarction and to determine if a social
incentive improves adherence with monitoring. Enrolled subjects will all have a history of
cerebral infarction and uncontrolled blood pressure, defined by SBP>140 or DBP>90 mm Hg at
the time of enrollment. To be eligible subjects will also be required to own a smart phone
(iOS or Android operating system). After enrollment, patients will be given a home blood
pressure cuff with instructions to monitor their BP twice daily for 90 days. Subjects will be
randomly assigned to a social incentive program, in which a social supporter receives updates
via email and/or text message on the subject's adherence with BP monitoring and their average
blood pressure. This study will provide important pilot data which will inform the design of
future studies utilizing connected health and automated systems to improve home blood
pressure monitoring and blood pressure control in patients with a history of stroke.
hypertensive patients with a history of cerebral infarction and to determine if a social
incentive improves adherence with monitoring. Enrolled subjects will all have a history of
cerebral infarction and uncontrolled blood pressure, defined by SBP>140 or DBP>90 mm Hg at
the time of enrollment. To be eligible subjects will also be required to own a smart phone
(iOS or Android operating system). After enrollment, patients will be given a home blood
pressure cuff with instructions to monitor their BP twice daily for 90 days. Subjects will be
randomly assigned to a social incentive program, in which a social supporter receives updates
via email and/or text message on the subject's adherence with BP monitoring and their average
blood pressure. This study will provide important pilot data which will inform the design of
future studies utilizing connected health and automated systems to improve home blood
pressure monitoring and blood pressure control in patients with a history of stroke.
Inclusion Criteria:
- Adult, age ≥ 18 years
- History of ischemic stroke or high risk TIA (defined by ABCD2 ≥ 4)between 2 weeks and
12 months prior to enrollment
- Hypertensive at time of enrollment, defined by SBP>140 mm Hg or DBP >90 mm Hg at the
time of study screening
- Must own a smart phone capable of interacting with the connected blood pressure cuff
(Apple iPhone 3GS or higher; Android 4.0 or higher with Bluetooth connectivity)
- Willingness and ability to sign informed consent by patient
Exclusion Criteria:
- Moderate or severe disability, defined by modified Rankin Scale ≥ 3.
- Expected residence in a rehabilitation hospital, nursing facility or assisted living
community during the study period.
- Upper arm circumference <9 inches or >17 inches
- Inability to monitor BP in both of the upper arms (i.e. history of bilateral radical
mastectomy, bilateral severe subclavian stenosis, or bilateral arterial venous
fistulas for dialysis).
- Blood pressure discrepancy between arms of >10 mm Hg.
- Inability to follow-up at 90 days and return BP monitor
- Active participation in another clinical trial
- Pregnant women
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Principal Investigator: Michael Mullen, M.D
Phone: 215-349-8651
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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