Clinical trial NCT02506244: mHealth Screening to Prevent Strokes
Official title: mHealth Screening to Prevent Strokes (mSToPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Wearable device
Wristband
ECG Patch
Strokes
Asymptomatic
Heart Rhythm
Home Monitoring
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
name: Aetna, Inc.
First posted: 2015-07-23
Enrollment: 6135
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
timeFrame: End of 4 month monitoring period
Secondary outcomes:
measure: Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls
timeFrame: 1 year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Translational Science Institute
state: California
Study officials:
affiliation: Study Principal Investigator
name: Steven R Steinhubl
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.