mHealth Screening to Prevent Strokes

Scripps Translational Science Institute6,135 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

6,135

Conditions

Atrial Fibrillation

Interventions

iRhythm ZIO XT PatchDEVICE

Single-lead ECG monitoring via a wearable patch

Wristband by AmiigoDEVICE

Determines pulse rate using photoplethysmography.

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

Participants: The study population will be derived from the Aetna and Medicare populations. Inclusion Criteria: * 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

Locations (1)

Scripps Translational Science Institute

La Jolla, California, United States

Outcomes

Primary Outcomes

Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group

Incidence of newly diagnosed AF as defined by at least 30 seconds of AF or atrial flutter at the end of the 4 month monitoring period compared to the delayed monitoring cohort (primary) and observational control (secondary)

Time frame: End of 4 month monitoring period

Secondary Outcomes

Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls

In the observational study, over 12 months of follow-up, we looked at the prevalence of AF in the actively monitored and delayed monitored cohorts.

Time frame: 1 year

Data from ClinicalTrials.gov

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