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Completed

NCT Number: NCT02450760

Connected Health Blood Pressure Monitoring In Stroke and TIA Patients

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.

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Key information

Conditions

Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social incentive

Other

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

Primary outcomes

  1. Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed

    Time frame: 90 Days

    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 outcomes

  1. Change in Systolic Blood Pressure Over Study Period

    Time frame: 90 days

    Difference in systolic blood pressure from the first 7 days of measurement to the last 7 days of measurement for each subject

  2. Number of Physician Visits

    Time frame: 90 days

  3. Number of Emergency Department Visits

    Time frame: 90 days

  4. Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent)

    Time frame: 90 days

  5. Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use

    Time frame: 90 days

    Number of patients who felt that device was easy or very easy to use

  6. Number of Patients That Perceived Blood Pressure Monitoring to be Useful

    Time frame: 90 days

    Number of participants who felt that BP monitoring was useful or very useful

  7. Number of Patients Who Felt They Had Well-controlled Blood Pressure

    Time frame: 90 days

    Patients perception of whether or not BP was well controlled

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: CHAMPS

Important dates

Study start
2015
Primary completion
2018
Study completion
2021
First posted
May 21, 2015
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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