mHealth Screening to Prevent Strokes (mSToPS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02506244 |
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Recruitment Status :
Completed
First Posted : July 23, 2015
Results First Posted : December 8, 2022
Last Update Posted : December 8, 2022
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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 : | 6135 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 |
|---|---|
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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. |
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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 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)
- Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls [ Time Frame: 1 year ]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.
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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 |
Documents provided by Steven Steinhubl, Scripps Translational Science Institute:
| 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 |
| Results First Posted: | December 8, 2022 |
| Last Update Posted: | December 8, 2022 |
| Last Verified: | June 2022 |
| 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 |
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Atrial Fibrillation Wearable device Wristband ECG Patch |
Strokes Asymptomatic Heart Rhythm Home Monitoring |
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Atrial Fibrillation Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes |