mHealth Screening to Prevent Strokes

Study Overview
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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.

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.

Official Title
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mHealth Screening to Prevent Strokes (mSToPS)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: iRhythm ZIO XT Patch
* Device: Wristband by Amiigo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Monitoring<br>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. | Device: iRhythm ZIO XT Patch<br>* Single-lead ECG monitoring via a wearable patch<br>Device: Wristband by Amiigo<br>* Determines pulse rate using photoplethysmography.<br>|
| Active Comparator: Delayed Monitoring<br>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. | Device: iRhythm ZIO XT Patch<br>* Single-lead ECG monitoring via a wearable patch<br>Device: Wristband by Amiigo<br>* Determines pulse rate using photoplethysmography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | End of 4 month monitoring period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Wearable device, Wristband, ECG Patch, Strokes, Asymptomatic, Heart Rhythm, Home Monitoring