Connected Health Blood Pressure Monitoring In Stroke and TIA Patients

Stroke Clinical Trial

— CHAMPS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450760
• Other study ID #: 821743
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: July 2021

Study information

• Verified date: December 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2021
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Physician Visits		90 days
Secondary	Number of Emergency Department Visits		90 days
Secondary	Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent)		90 days
Secondary	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
Secondary	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
Secondary	Number of Patients Who Felt They Had Well-controlled Blood Pressure	Patients perception of whether or not BP was well controlled	90 days