mHealth Screening to Prevent Strokes (mSToPS)

Scripps Translational Science Institute

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Wristband by Amiigo; Device: iRhythm ZIO XT Patch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02506244

Version 3.5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,135 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,135 participants in 2 patient groups

Immediate Monitoring

Experimental group

Description:

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.

Treatment:

Device: Wristband by Amiigo

Device: iRhythm ZIO XT Patch

Delayed Monitoring

Active Comparator group

Description:

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.

Treatment:

Device: Wristband by Amiigo

Device: iRhythm ZIO XT Patch