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mHealth Screening to Prevent Strokes | Clinical Trials | Clareo Health

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COMPLETEDNANCT02506244

mHealth Screening to Prevent Strokes

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 i...

Lead sponsor: Scripps Translational Science Institute•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Scripps Translational Science Institute

Collaborators

Janssen Scientific Affairs, LLC
Aetna, Inc.

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.

Age

55 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Participants:
•The study population will be derived from the Aetna and Medicare populations.
•Male or females age \> 75 or
•Male age \> 55, or females age \> 65, and
•Prior CVA, or
•Heart failure, or
•Diagnosis of both diabetes and hypertension, or
•Mitral valve disease, or
•Left ventricular hypertrophy, or
•COPD requiring home O2, or
•Sleep apnea, or
•History of pulmonary embolism, or
•History of myocardial infarction, or
•Diagnosis of obesity

Exclusion Criteria

•Current or prior diagnosis of atrial fibrillation, atrial flutter or atrial tachycardia
•Receiving chronic anticoagulation therapy
•Hospice care
•End stage renal disease
•Diagnosis of moderate or greater dementia
•Implantable pacemaker and/or defibrillator
•History of skin allergies to adhesive patches
•Known metastatic cancer
•Aetna Compassionate Care Program (ACCP) participants - individuals with advanced illness and limited life expectancy

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 8, 2022Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment6,135

Start dateNov 2015

Last updatedDec 8, 2022

Condition

Atrial Fibrillation

Locations shown

Scripps Translational Science Institute

La Jolla, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2022Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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