Atrial FibrillationmSToPSNCT02506244
mHealth Screening to Prevent Strokes
A study testing iRhythm ZIO XT Patch and Wristband by Amiigo in people with Atrial Fibrillation, run by Scripps Translational Science Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- iRhythm ZIO XT Patch and Wristband by Amiigo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,135 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- History of skin allergies to adhesive patches
- Known metastatic cancer
- Aetna Compassionate Care Program (ACCP) participants - individuals with advanced illness and limited life expectancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Translational Science Institute
La Jolla, California, 92037
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- iRhythm ZIO XT Patch, Wristband by Amiigo
- Keywords
- Atrial Fibrillation, Wearable device, Wristband, ECG Patch, Strokes, Asymptomatic, Heart Rhythm, Home Monitoring
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iRhythm ZIO XT PatchDevice
Single-lead ECG monitoring via a wearable patch
Wristband by AmiigoDevice
Determines pulse rate using photoplethysmography.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: iRhythm ZIO XT Patch; Device: 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. Receives: Device: iRhythm ZIO XT Patch; Device: Wristband by Amiigo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: End of 4 month monitoring period
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Aetna, Inc.
- Responsible party
- Principal investigator, Steven Steinhubl, Scripps Translational Science Institute
- Investigators
- Steven R Steinhubl, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506244
- Sponsor's protocol ID
- Version 3.5
- Acronym
- mSToPS
- Status last verified
- Jun 2022
- First submitted
- 17 Jul 2015
- Last updated
- 8 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37905421Steinhubl 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.
PubMed 34610049Baca-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.
PubMed 30656241Steinhubl 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.
PubMed 29998336
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Screening to Prevent Strokes (mSToPS)
- ClinicalTrials.gov ID
- NCT02506244
- Acronym / sponsor ID
- mSToPS / Version 3.5
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Wearable device, Wristband, ECG Patch, Strokes, Asymptomatic, Heart Rhythm, Home Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,135 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Aetna, Inc.
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Posted 8 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Monitoring | Experimental | Device: iRhythm ZIO XT Patch, Device: Wristband by AmiigoIndividuals 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. |
| Delayed Monitoring | Active comparator | Device: iRhythm ZIO XT Patch, Device: Wristband by AmiigoIndividuals 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iRhythm ZIO XT PatchSingle-lead ECG monitoring via a wearable patch | Device | Delayed Monitoring, Immediate Monitoring |
| Wristband by AmiigoDetermines pulse rate using photoplethysmography. | Device | Delayed Monitoring, Immediate Monitoring |
Primary outcome
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)
1 secondary outcome
Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37905421Reynolds 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.
- Derived from this study: PubMed 34610049Steinhubl 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.
- Derived from this study: PubMed 30656241Baca-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.
- Derived from this study: PubMed 29998336Steinhubl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Steinhubl principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iRhythm ZIO XT Patch and Wristband by Amiigo in people with Atrial Fibrillation, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group (time frame: End of 4 month monitoring period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506244, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.