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mHealth Screening to Prevent Strokes (mSToPS)

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ClinicalTrials.gov Identifier: NCT02506244
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : January 13, 2021
Sponsor:
Collaborators:
Janssen Scientific Affairs, LLC
Aetna, Inc.
Information provided by (Responsible Party):
Steven Steinhubl, Scripps Translational Science Institute

Tracking Information
First Submitted Date  ICMJE July 17, 2015
First Posted Date  ICMJE July 23, 2015
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2020)
  • 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.
  • 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.
  • Difference in total healthcare costs in AF cohorts of monitored and controls [ Time Frame: 3 years ]
    Evaluation if there is a difference in healthcare costs with monitored individuals compared to controls with respect to AF
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
  • 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.
  • 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.
  • Difference in total healthcare costs in AF cohorts of monitored and controls [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE mHealth Screening to Prevent Strokes
Official Title  ICMJE mHealth Screening to Prevent Strokes (mSToPS)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Device: iRhythm ZIO XT Patch
    Single-lead ECG monitoring via a wearable patch
  • Device: Wristband by Amiigo
    Determines pulse rate using photoplethysmography.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Device: iRhythm ZIO XT Patch
    • Device: Wristband by Amiigo
  • 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.

    Interventions:
    • Device: iRhythm ZIO XT Patch
    • Device: Wristband by Amiigo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2017)
2274
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2015)
2000
Actual Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02506244
Other Study ID Numbers  ICMJE Version 3.5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Steven Steinhubl, Scripps Translational Science Institute
Study Sponsor  ICMJE Scripps Translational Science Institute
Collaborators  ICMJE
  • Janssen Scientific Affairs, LLC
  • Aetna, Inc.
Investigators  ICMJE
Principal Investigator: Steven R Steinhubl Study Principal Investigator
PRS Account Scripps Translational Science Institute
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP