Back to resultsmHealth Screening to Prevent Strokes (mSToPS)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iRhythm ZIO XT Patch
Wristband by Amiigo
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Wearable device, Wristband, ECG Patch, Strokes, Asymptomatic, Heart Rhythm, Home Monitoring
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
Sites / Locations
- Scripps Translational Science Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate Monitoring
Delayed Monitoring
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls
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.
Full Information
NCT ID
NCT02506244
First Posted
July 17, 2015
Last Updated
November 8, 2022
Sponsor
Scripps Translational Science Institute
Collaborators
Janssen Scientific Affairs, LLC, Aetna, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02506244
Brief Title
mHealth Screening to Prevent Strokes
Acronym
mSToPS
Official Title
mHealth Screening to Prevent Strokes (mSToPS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Translational Science Institute
Collaborators
Janssen Scientific Affairs, LLC, Aetna, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Wearable device, Wristband, ECG Patch, Strokes, Asymptomatic, Heart Rhythm, Home Monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Monitoring
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
iRhythm ZIO XT Patch
Intervention Description
Single-lead ECG monitoring via a wearable patch
Intervention Type
Device
Intervention Name(s)
Wristband by Amiigo
Intervention Description
Determines pulse rate using photoplethysmography.
Primary Outcome Measure Information:
Title
Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
Description
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)
Time Frame
End of 4 month monitoring period
Secondary Outcome Measure Information:
Title
Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Steinhubl
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Translational Science Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34610049
Citation
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.
Results Reference
derived
PubMed Identifier
30656241
Citation
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.
Results Reference
derived
PubMed Identifier
29998336
Citation
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.
Results Reference
derived
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mHealth Screening to Prevent Strokes
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