mHealth Screening to Prevent Strokes (mSToPS)

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

Tracking Information

• First Submitted Date: July 17, 2015
• First Posted Date: July 23, 2015
• Last Update Posted Date: January 13, 2021
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: mHealth Screening to Prevent Strokes
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Atrial Fibrillation

Intervention

• Device: iRhythm ZIO XT Patch
  Single-lead ECG monitoring via a wearable patch
• Device: Wristband by Amiigo
  Determines pulse rate using photoplethysmography.

Study Arms

• 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 *

• Baca-Motes K, Edwards AM, Waalen J, Edmonds S, Mehta RR, Ariniello L, Ebner GS, Talantov D, Fastenau JM, Carter CT, Sarich TC, Felicione E, Topol EJ, Steinhubl SR. Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial. Contemp Clin Trials Commun. 2019 Jan 7;14:100318. doi: 10.1016/j.conctc.2019.100318. eCollection 2019 Jun.
• Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T, Topol EJ. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155. doi: 10.1001/jama.2018.8102.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 20, 2017): 2274
• Original Estimated Enrollment (submitted: July 21, 2015): 2000
• Actual Study Completion Date: December 31, 2020
• Actual Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02506244
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Steven Steinhubl, Scripps Translational Science Institute
• Study Sponsor: Scripps Translational Science Institute

Collaborators

• Janssen Scientific Affairs, LLC
• Aetna, Inc.

Investigators

• Principal Investigator: Steven R Steinhubl; Study Principal Investigator

• PRS Account: Scripps Translational Science Institute
• Verification Date: January 2021