Connected Health Blood Pressure Monitoring In Stroke and TIA Patients

NCT02450760 | Completed Results

• 1 other identifier: 821743
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Systolic Blood Pressure Over Study Period

  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

  90 days

Study Arms (2)

Control

OTHER

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

Social Incentive

OTHER

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

Interventions

Social incentive OTHER

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

Control; Social Incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Results Point of Contact

• Title: Michael Mullen
• Organization: University of Pennsylvania

Michael.Mullen@Pennmedicine.Upenn.edu

215-662-3339

Study Officials

• Michael Mullen, M.D

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 21, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2021
• Last Updated: February 17, 2022
• Results First Posted: February 17, 2022

Record last verified: 2021-12

Locations

US (1)