mHealth Screening to Prevent Strokes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immediate Monitoring

Individuals randomized to immediate monitoring will receive the ZIO XT patch sensor and wear it for the first and last 2 week period of the 4 month monitoring period of time 0 to 4 months.

Note: Approximately 250 consenting participants will also be invited to participate in a sub-study to wear an additional monitoring device (Amiigo wristband) continuously over the 4 month monitoring period.

Group Type EXPERIMENTAL

iRhythm ZIO XT Patch

Intervention Type DEVICE

Single-lead ECG monitoring via a wearable patch

Wristband by Amiigo

Intervention Type DEVICE

Determines pulse rate using photoplethysmography.

Delayed Monitoring

Individuals randomized to delayed monitoring will receive usual care for 4 months after which they will receive the ZIO XT patch sensor and wear it for the first and last 2 week period of study months 4 through 8.

Note: Approximately 250 consenting participants will also be invited to participate in a sub-study to wear an additional monitoring device (Amiigo wristband) daily for months 4 through 8.

Group Type ACTIVE_COMPARATOR

iRhythm ZIO XT Patch

Intervention Type DEVICE

Single-lead ECG monitoring via a wearable patch

Wristband by Amiigo

Intervention Type DEVICE

Determines pulse rate using photoplethysmography.

Interventions

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iRhythm ZIO XT Patch

Single-lead ECG monitoring via a wearable patch

Intervention Type DEVICE

Wristband by Amiigo

Determines pulse rate using photoplethysmography.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No