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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
| Aetna, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iRhythm ZIO XT Patch | Device | Single-lead ECG monitoring via a wearable patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Participants:
The study population will be derived from the Aetna and Medicare populations.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Steinhubl | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Translational Science Institute | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37905421 | Derived | 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. | |
| 34610049 | Derived | 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. |
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This was an observational study with two study arms, an immediate monitoring group and a delayed monitoring group. This was not a cross-over design study. The control group for this study consisted of participants that were not given the Zio patch. This group was used to compare who got routine care compared to the other arms that received the Zio patches.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch Wristband by Amiigo: Determines pulse rate using photoplethysmography. |
| FG001 | 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. iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch Wristband by Amiigo: Determines pulse rate using photoplethysmography. |
| FG002 | Match Controls | Observational matched controls that underwent routine care and were not given a Zio patch |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch Wristband by Amiigo: Determines pulse rate using photoplethysmography. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | In the intention-to-treat analysis of the randomized clinical trial, we analyzed the incidence of new AF cases in the immediate monitoring group vs the delayed monitoring groups. | Posted | Count of Participants | Participants | End of 4 month monitoring period |
|
1 year
The only adverse events reported in this study were in relation to skin irritations developed from wearing the Zio patch. There was no risk of all-cause mortality or serious adverse events connected to wearing the patch so all-cause mortality and serious adverse events were not monitored/assessed The observational controls did not receive a patch and thus were not actively monitored for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch Wristband by Amiigo: Determines pulse rate using photoplethysmography. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation from Zio XT patch | Skin and subcutaneous tissue disorders | Systematic Assessment | Minor skin irritation that resulted from wearing the patch. All resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven R. Steinhul, MD, Prinicipal Investigator | Scripps Research Translational Institute | 858-554-5757 | steinhub@scripps.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2016 | May 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2017 | May 4, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Wristband by Amiigo | Device | Determines pulse rate using photoplethysmography. |
|
| 30656241 | Derived | 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. |
| 29998336 | Derived | 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. |
| BG001 | 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. iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch Wristband by Amiigo: Determines pulse rate using photoplethysmography. |
| BG002 | Matched Controls | Individuals that underwent routine care and were not given a Zio XT patch sensor. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch Wristband by Amiigo: Determines pulse rate using photoplethysmography. |
|
|
| Secondary | 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. | 906 participants that were in the immediate monitoring group had 12 months of follow-up data, 832 participants in the delayed monitoring group had 12 months of follow-up data | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 20 |
| 908 |
| EG001 | 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. iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch Wristband by Amiigo: Determines pulse rate using photoplethysmography. | 0 | 0 | 0 | 0 | 21 | 834 |
|
| Skin irritation from Amigo wristband | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| Male |
|