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Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm

NCT03515083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-06-12

No results posted yet for this study

Summary

There is a need to determine actual compliance of direct oral anticoagulants and how to improve this to reduce risk of stroke in patients with atrial fibrillation. Mobile health tools have been implemented world-wide in various patient populations as means of reducing cardiovascular risk and improving disease management. Results of these interventions have been mixed with some interventions demonstrating significant improvement while others demonstrated no difference between the intervention group and the control group. More importantly, these studies indicate that implementation of mobile health tools is feasible in various patient populations and it may just be a matter of finding the correct intervention for a given disease state. The aim of this study is to increase awareness of atrial fibrillation as a means of improving compliance with anticoagulant medication.

Conditions

  • Non-valvular Atrial Fibrillation

Interventions

DEVICE

Alive Cor Kardia mobile electrocardiogram monitor

Mobile ECG monitor paired with smart phone application

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • AliveCor

    collaborator INDUSTRY

  • Saint Luke's Health System

    lead OTHER

Principal Investigators

  • Sanjaya Gupta, MD · Saint Luke's Health System

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2022-06-01
Completion
2022-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03515083 on ClinicalTrials.gov