mHealth Screening to Prevent Strokes "mSToPS"

Active, not recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to investigate whether it is possible to identify a high-risk cohort suitable for screening for asymptomatic atrial fibrillation using claims data, and then engage those individuals in a mobile health technology-enabled home monitoring program in order to document previously undiagnosed atrial fibrillation, and provide clinical evidence of an outcomes benefit associated with this early detection.

Detailed Description

The purpose of this study is to propose to study two different methods of intermittent rhythm monitoring in a cohort of individuals without prior history of atrial fibrillation, but determined to be at increased risk based on clinical risk factors, and compare the rate of atrial fibrillation detection through monitoring relative to routine care.

Conditions

Interventions

  • IRhythm ZIO XT Patch Device
    Intervention Desc: Single-lead ECG monitoring via a wearable patch
    ARM 1: Kind: Experimental
    Label: Immediate Monitoring
    Description: Individuals randomized to immediate monitoring will receive the ZIO XT patch sensor and wear it for the first and last 2 week period of the 4 month monitoring period of time 0 to 4 months. Note: Approximately 250 consenting participants will also be invited to participate in a sub-study to wear an additional monitoring device (Amiigo wristband) continuously over the 4 month monitoring period.
    ARM 2: Kind: Experimental
    Label: Delayed Monitoring
    Description: Individuals randomized to delayed monitoring will receive usual care for 4 months after which they will receive the ZIO XT patch sensor and wear it for the first and last 2 week period of study months 4 through 8. Note: Approximately 250 consenting participants will also be invited to participate in a sub-study to wear an additional monitoring device (Amiigo wristband) daily for months 4 through 8.
  • Wristband by Amiigo Device
    Intervention Desc: Determines pulse rate using photoplethysmography.
    ARM 1: Kind: Experimental
    Label: Immediate Monitoring
    Description: Individuals randomized to immediate monitoring will receive the ZIO XT patch sensor and wear it for the first and last 2 week period of the 4 month monitoring period of time 0 to 4 months. Note: Approximately 250 consenting participants will also be invited to participate in a sub-study to wear an additional monitoring device (Amiigo wristband) continuously over the 4 month monitoring period.
    ARM 2: Kind: Experimental
    Label: Delayed Monitoring
    Description: Individuals randomized to delayed monitoring will receive usual care for 4 months after which they will receive the ZIO XT patch sensor and wear it for the first and last 2 week period of study months 4 through 8. Note: Approximately 250 consenting participants will also be invited to participate in a sub-study to wear an additional monitoring device (Amiigo wristband) daily for months 4 through 8.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of newly diagnosed AF End of 4 month monitoring period No
Secondary Prevalence of atrial fibrillation 1 year No
Secondary Time to first event of the combined endpoint of stroke, systemic emboli, or MI in patients diagnosed with AF in monitored vs. control cohorts. 3 years No
Secondary Difference in total healthcare costs in AF cohorts of monitored and controls 3 years No

Sponsors