mHealth Screening to Prevent Strokes (mSToPS)

November 8, 2022 updated by: Steven Steinhubl, Scripps Translational Science Institute

mHealth Screening to Prevent Strokes (mSToPS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

6135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Translational Science Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
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)
End of 4 month monitoring period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls
Time Frame: 1 year
In the observational study, over 12 months of follow-up, we looked at the prevalence of AF in the actively monitored and delayed monitored cohorts.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Collaborators

Janssen Scientific Affairs, LLC
Aetna, Inc.

Investigators

  • Principal Investigator: Steven R Steinhubl, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 3.5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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