mHealth Screening to Prevent Strokes



Status:Active, not recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:55 - Any
Updated:7/8/2018
Start Date:November 2015
End Date:September 2020

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mHealth Screening to Prevent Strokes (mSToPS)

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.

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
We found this trial at
1
site
La Jolla, California 92037
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from
La Jolla, CA
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