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mHealth Screening to Prevent Strokes (mSToPS)

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ClinicalTrials.gov Identifier: NCT02506244
Recruitment Status : Active, not recruiting
First Posted : July 23, 2015
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
Janssen Scientific Affairs, LLC
Aetna, Inc.
Information provided by (Responsible Party):
Steven Steinhubl, Scripps Translational Science Institute

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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)
Study Start Date : November 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of newly diagnosed AF [ 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 Outcome Measures :
  1. Prevalence of atrial fibrillation [ Time Frame: 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.


  2. Time to first event of the combined endpoint of stroke, systemic emboli, or MI in patients diagnosed with AF in monitored vs. control cohorts. [ Time Frame: 3 years ]
    Clinical outcomes will be determined using claims data and compared between the monitored and observational cohorts.

  3. Difference in total healthcare costs in AF cohorts of monitored and controls [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506244


Locations
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United States, California
Scripps Translational Science Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Janssen Scientific Affairs, LLC
Aetna, Inc.
Investigators
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Principal Investigator: Steven R Steinhubl Study Principal Investigator
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steven Steinhubl, Director, Digital Medicine, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT02506244     History of Changes
Other Study ID Numbers: Version 3.5
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Steven Steinhubl, Scripps Translational Science Institute:
Atrial Fibrillation
Wearable device
Wristband
ECG Patch
 Strokes
Asymptomatic
Heart Rhythm
Home Monitoring

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes