NCT02506244

mHealth Screening to Prevent Strokes

mHealth Screening to Prevent Strokes (mSToPS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,135 (actual)
• Sponsor: Scripps Translational Science Institute · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	iRhythm ZIO XT Patch	Single-lead ECG monitoring via a wearable patch
DEVICE	Wristband by Amiigo	Determines pulse rate using photoplethysmography.

Timeline

• Start date: 2015-11-01
• Primary completion: 2020-09-01
• Completion: 2020-12-31
• First posted: 2015-07-23
• Last updated: 2022-12-08
• Results posted: 2022-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study