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

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ClinicalTrials.gov Identifier: NCT02450760
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Stroke Ischemic Attack, Transient Other: Social incentive Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : November 2015
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Adherence with home blood pressure monitoring, defined by the proportion of home blood pressure recordings successfully completed [ Time Frame: 90 Days ]

Secondary Outcome Measures :
  1. Change in blood pressure over the 90 day study period [ Time Frame: 90 days ]
  2. Number of physician visits [ Time Frame: 90 days ]
  3. Number of emergency department visits [ Time Frame: 90 days ]
  4. Number of phone calls to the study team [ Time Frame: 90 days ]
  5. Number of changes in antihypertensive medications (dose adjustment or addition of a new agent) [ Time Frame: 90 days ]
  6. Patients perception of blood pressure monitoring device ease of use [ Time Frame: 90 days ]
  7. Patients perception of the utility of blood pressure monitoring [ Time Frame: 90 days ]
  8. Patients perception of blood pressure control [ Time Frame: 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450760


Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Michael Mullen, M.D University of Pennsylvania

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02450760     History of Changes
Other Study ID Numbers: 821743
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Stroke
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia