Connected Health Blood Pressure Monitoring In Stroke and TIA Patients

NCT ID: NCT02450760

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2021-07-31

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.

Conditions

Stroke; Ischemic Attack, Transient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: OTHER

Social incentive

Intervention Type: OTHER

Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence

Social Incentive

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.

Group Type: OTHER

Social incentive

Intervention Type: OTHER

Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence

Interventions

Social incentive

Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Mullen, M.D

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

821743

Identifier Type: -

Identifier Source: org_study_id