Connected Health Blood Pressure Monitoring In Stroke and TIA Patients (CHAMPS)

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Ischemic Attack, Transient
• Intervention / Treatment: Other: Social incentive

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: Social incentive; Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence
Other: 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.	Other: Social incentive; Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed	Percentage of requested blood pressure measurements completed. Note that subjects were enrolled for 90 +/- 7 days, and so this calculation was completed at day 83, rather than day 90.	90 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure Over Study Period	Difference in systolic blood pressure from the first 7 days of measurement to the last 7 days of measurement for each subject	90 days
Number of Physician Visits		90 days
Number of Emergency Department Visits		90 days
Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent)		90 days
Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use	Number of patients who felt that device was easy or very easy to use	90 days
Number of Patients That Perceived Blood Pressure Monitoring to be Useful	Number of participants who felt that BP monitoring was useful or very useful	90 days
Number of Patients Who Felt They Had Well-controlled Blood Pressure	Patients perception of whether or not BP was well controlled	90 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Michael Mullen, M.D, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 18, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: 821743