mHealth Screening to Prevent Strokes (mSToPS)
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ClinicalTrials.gov Identifier: NCT02506244 |
Recruitment Status :
Completed
First Posted : July 23, 2015
Last Update Posted : January 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation | Device: iRhythm ZIO XT Patch Device: Wristband by Amiigo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2274 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | mHealth Screening to Prevent Strokes (mSToPS) |
Actual Study Start Date : | November 2015 |
Actual Primary Completion Date : | September 2020 |
Actual Study Completion Date : | December 31, 2020 |

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. |
- Incidence of newly diagnosed AF [ 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)
- Prevalence of atrial fibrillation [ Time Frame: 1 year ]
Comparison of the rate of newly diagnosed AF in the entire monitored cohort compared to that in the matched cohort.
Difference in healthcare utilization/costs.
- Time to first event of the combined endpoint of stroke, systemic emboli, or MI in patients diagnosed with AF in monitored vs. control cohorts. [ Time Frame: 3 years ]Clinical outcomes will be determined using claims data and compared between the monitored and observational cohorts.
- Difference in total healthcare costs in AF cohorts of monitored and controls [ Time Frame: 3 years ]Evaluation if there is a difference in healthcare costs with monitored individuals compared to controls with respect to AF

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506244
United States, California | |
Scripps Translational Science Institute | |
La Jolla, California, United States, 92037 |
Principal Investigator: | Steven R Steinhubl | Study Principal Investigator |
Responsible Party: | Steven Steinhubl, Director, Digital Medicine, Scripps Translational Science Institute |
ClinicalTrials.gov Identifier: | NCT02506244 |
Other Study ID Numbers: |
Version 3.5 |
First Posted: | July 23, 2015 Key Record Dates |
Last Update Posted: | January 13, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Atrial Fibrillation Wearable device Wristband ECG Patch |
Strokes Asymptomatic Heart Rhythm Home Monitoring |
Atrial Fibrillation Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes |