mHealth Screening to Prevent Strokes (mSToPS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Scripps Translational Science Institute
- Enrollment
- 6135
- Locations
- 1
- Primary Endpoint
- Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Steven Steinhubl
Director, Digital Medicine
Scripps Translational Science Institute
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
Time Frame: End of 4 month monitoring period
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)
Secondary Outcomes
- Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls(1 year)