mHealth Screening to Prevent Strokes
- Conditions
- Atrial Fibrillation
- Interventions
- Device: iRhythm ZIO XT PatchDevice: Wristband by Amiigo
- Registration Number
- NCT02506244
- Lead Sponsor
- Scripps Translational Science Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6135
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed Monitoring iRhythm ZIO XT Patch 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. Delayed Monitoring Wristband by Amiigo 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. Immediate Monitoring iRhythm ZIO XT Patch 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. Immediate Monitoring Wristband by Amiigo 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.
- Primary Outcome Measures
Name Time Method Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group 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 Outcome Measures
Name Time Method Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls 1 year 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.
Trial Locations
- Locations (1)
Scripps Translational Science Institute
🇺🇸La Jolla, California, United States