NCT02506244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,135

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 8, 2022

Completed
Last Updated

December 8, 2022

Status Verified

June 1, 2022

Enrollment Period

4.8 years

First QC Date

July 17, 2015

Results QC Date

May 4, 2022

Last Update Submit

November 8, 2022

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationWearable deviceWristbandECG PatchStrokesAsymptomaticHeart RhythmHome Monitoring

Outcome Measures

Primary Outcomes (1)

  • Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group

    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 Outcomes (1)

  • Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls

    1 year

Study Arms (2)

Immediate Monitoring

EXPERIMENTAL

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 PatchDevice: Wristband by Amiigo

Delayed Monitoring

ACTIVE COMPARATOR

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 PatchDevice: Wristband by Amiigo

Interventions

iRhythm ZIO XT PatchDEVICE

Single-lead ECG monitoring via a wearable patch

Delayed MonitoringImmediate Monitoring
Wristband by AmiigoDEVICE

Determines pulse rate using photoplethysmography.

Delayed MonitoringImmediate Monitoring

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Translational Science Institute

La Jolla, California, 92037, United States

Location

Related Publications (4)

  • Reynolds MR, Stein AB, Sun X, Hytopoulos E, Steinhubl SR, Cohen DJ. Cost-Effectiveness of AF Screening With 2-Week Patch Monitors: The mSToPS Study. Circ Cardiovasc Qual Outcomes. 2023 Nov;16(11):e009751. doi: 10.1161/CIRCOUTCOMES.122.009751. Epub 2023 Oct 31.

    PMID: 37905421DERIVED

  • Steinhubl SR, Waalen J, Sanyal A, Edwards AM, Ariniello LM, Ebner GS, Baca-Motes K, Zambon RA, Sarich T, Topol EJ. Three year clinical outcomes in a nationwide, observational, siteless clinical trial of atrial fibrillation screening-mHealth Screening to Prevent Strokes (mSToPS). PLoS One. 2021 Oct 5;16(10):e0258276. doi: 10.1371/journal.pone.0258276. eCollection 2021.

    PMID: 34610049DERIVED

  • 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.

    PMID: 30656241DERIVED

  • 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.

    PMID: 29998336DERIVED

MeSH Terms

Conditions

Atrial FibrillationStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Results Point of Contact

Title
Steven R. Steinhul, MD, Prinicipal Investigator
Organization
Scripps Research Translational Institute
steinhub@scripps.edu
858-554-5757

Study Officials

  • Steven R Steinhubl

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Digital Medicine

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 23, 2015

Study Start

November 1, 2015

Primary Completion

September 1, 2020

Study Completion

December 31, 2020

Last Updated

December 8, 2022

Results First Posted

December 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)