Connected Health Blood Pressure Monitoring In Stroke and TIA Patients "CHAMPS"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Social incentive Other
    Intervention Desc: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence
    ARM 1: Kind: Experimental
    Label: Control
    Description: Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. If subjects miss blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. Subjects will also receive weekly emails with their blood pressure data for the week.
    ARM 2: Kind: Experimental
    Label: Social Incentive
    Description: Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Adherence with home blood pressure monitoring, defined by the proportion of home blood pressure recordings successfully completed 90 Days No
Secondary Change in blood pressure over the 90 day study period 90 days No
Secondary Number of physician visits 90 days No
Secondary Number of emergency department visits 90 days No
Secondary Number of phone calls to the study team 90 days No
Secondary Number of changes in antihypertensive medications (dose adjustment or addition of a new agent) 90 days No
Secondary Patients perception of blood pressure monitoring device ease of use 90 days No
Secondary Patients perception of the utility of blood pressure monitoring 90 days No
Secondary Patients perception of blood pressure control 90 days No

Sponsors