- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02506244
mHealth Screening to Prevent Strokes (mSToPS)
mHealth Screening to Prevent Strokes (mSToPS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Scripps Translational Science Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
Single-lead ECG monitoring via a wearable patch
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. |
Single-lead ECG monitoring via a wearable patch
Determines pulse rate using photoplethysmography.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
End of 4 month monitoring period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Steven R Steinhubl, Study Principal Investigator
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Version 3.5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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