This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02450760
First received: May 18, 2015
Last updated: October 27, 2016
Last verified: October 2016
May 18, 2015
October 27, 2016
November 2015
January 2018   (Final data collection date for primary outcome measure)
Adherence with home blood pressure monitoring, defined by the proportion of home blood pressure recordings successfully completed [ Time Frame: 90 Days ]
Same as current
Complete list of historical versions of study NCT02450760 on ClinicalTrials.gov Archive Site
  • Change in blood pressure over the 90 day study period [ Time Frame: 90 days ]
  • Number of physician visits [ Time Frame: 90 days ]
  • Number of emergency department visits [ Time Frame: 90 days ]
  • Number of phone calls to the study team [ Time Frame: 90 days ]
  • Number of changes in antihypertensive medications (dose adjustment or addition of a new agent) [ Time Frame: 90 days ]
  • Patients perception of blood pressure monitoring device ease of use [ Time Frame: 90 days ]
  • Patients perception of the utility of blood pressure monitoring [ Time Frame: 90 days ]
  • Patients perception of blood pressure control [ Time Frame: 90 days ]
Same as current
Not Provided
Not Provided
 
Connected Health Blood Pressure Monitoring In Stroke and TIA Patients
Not Provided
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Stroke
  • Ischemic Attack, Transient
Other: Social incentive
Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence
  • 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.
    Intervention: Other: Social incentive
  • 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.
    Intervention: Other: Social incentive
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Not Provided
January 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Nichole Gallatti, M.S.Ed 215-349-8651 nichole.gallatti@uphs.upenn.edu
United States
 
 
NCT02450760
821743
No
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Michael Mullen, M.D University of Pennsylvania
University of Pennsylvania
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP