mSToPS: mHealth Screening to Prevent Strokes

Sponsor

Scripps Translational Science Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02506244

Collaborator

Janssen Scientific Affairs, LLC (Industry), Aetna, Inc. (Industry)

2,274

Enrollment

Location

Arms

Actual Duration (Months)

36.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: iRhythm ZIO XT Patch Device: Wristband by Amiigo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2274 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

mHealth Screening to Prevent Strokes (mSToPS)

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Sep 1, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate Monitoring 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 Single-lead ECG monitoring via a wearable patch Device: Wristband by Amiigo Determines pulse rate using photoplethysmography.
Active Comparator: Delayed Monitoring 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 Single-lead ECG monitoring via a wearable patch Device: Wristband by Amiigo Determines pulse rate using photoplethysmography.

Arm

Intervention/Treatment

Experimental: Immediate Monitoring

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

Single-lead ECG monitoring via a wearable patch

Device: Wristband by Amiigo

Determines pulse rate using photoplethysmography.

Active Comparator: Delayed Monitoring

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

Single-lead ECG monitoring via a wearable patch

Device: Wristband by Amiigo

Determines pulse rate using photoplethysmography.

Outcome Measures

Primary Outcome Measures

Incidence of newly diagnosed AF [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

Prevalence of atrial fibrillation [1 year]
Comparison of the rate of newly diagnosed AF in the entire monitored cohort compared to that in the matched cohort. Difference in healthcare utilization/costs.
Time to first event of the combined endpoint of stroke, systemic emboli, or MI in patients diagnosed with AF in monitored vs. control cohorts. [3 years]
Clinical outcomes will be determined using claims data and compared between the monitored and observational cohorts.
Difference in total healthcare costs in AF cohorts of monitored and controls [3 years]
Evaluation if there is a difference in healthcare costs with monitored individuals compared to controls with respect to AF

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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