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mHealth Screening to Prevent Strokes

NCT02506244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6135

Last updated 2022-12-08

Study results available
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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.

Conditions

Interventions

DEVICE

iRhythm ZIO XT Patch

Single-lead ECG monitoring via a wearable patch

DEVICE

Wristband by Amiigo

Determines pulse rate using photoplethysmography.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Aetna, Inc.

    collaborator INDUSTRY

  • Scripps Translational Science Institute

    lead OTHER

Principal Investigators

  • Steven R Steinhubl · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-09-30
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506244 on ClinicalTrials.gov