Clinical trial NCT02450760: Connected Health Blood Pressure Monitoring In Stroke and TIA Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Ischemic Attack, Transient
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed
timeFrame: 90 Days
Secondary outcomes:
measure: Change in Systolic Blood Pressure Over Study Period
timeFrame: 90 days
measure: Number of Physician Visits
timeFrame: 90 days
measure: Number of Emergency Department Visits
timeFrame: 90 days
measure: Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent)
timeFrame: 90 days
measure: Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use
timeFrame: 90 days
measure: Number of Patients That Perceived Blood Pressure Monitoring to be Useful
timeFrame: 90 days
measure: Number of Patients Who Felt They Had Well-controlled Blood Pressure
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael Mullen, M.D
role: PRINCIPAL_INVESTIGATOR
References: