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

Primary Purpose

Stroke, Ischemic Attack, Transient

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social incentive
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control

Social Incentive

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Number of Physician Visits
Number of Emergency Department Visits
Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent)
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
Number of Patients That Perceived Blood Pressure Monitoring to be Useful
Number of participants who felt that BP monitoring was useful or very useful
Number of Patients Who Felt They Had Well-controlled Blood Pressure
Patients perception of whether or not BP was well controlled

Full Information

First Posted
May 18, 2015
Last Updated
December 2, 2021
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02450760
Brief Title
Connected Health Blood Pressure Monitoring In Stroke and TIA Patients
Acronym
CHAMPS
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Attack, Transient

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm 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 Title
Social Incentive
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Social incentive
Intervention Description
Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence
Primary Outcome Measure Information:
Title
Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed
Description
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.
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Change in Systolic Blood Pressure Over Study Period
Description
Difference in systolic blood pressure from the first 7 days of measurement to the last 7 days of measurement for each subject
Time Frame
90 days
Title
Number of Physician Visits
Time Frame
90 days
Title
Number of Emergency Department Visits
Time Frame
90 days
Title
Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent)
Time Frame
90 days
Title
Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use
Description
Number of patients who felt that device was easy or very easy to use
Time Frame
90 days
Title
Number of Patients That Perceived Blood Pressure Monitoring to be Useful
Description
Number of participants who felt that BP monitoring was useful or very useful
Time Frame
90 days
Title
Number of Patients Who Felt They Had Well-controlled Blood Pressure
Description
Patients perception of whether or not BP was well controlled
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Mullen, M.D
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Connected Health Blood Pressure Monitoring In Stroke and TIA Patients

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