mHealth Screening to Prevent Strokes

Atrial Fibrillation Clinical Trial

— mSToPS  

Official title:

mHealth Screening to Prevent Strokes (mSToPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506244
• Other study ID #: Version 3.5
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2022
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6135
• Est. completion date: December 31, 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• iRhythm ZIO XT Patch
Single-lead ECG monitoring via a wearable patch
• Wristband by Amiigo
Determines pulse rate using photoplethysmography.

Locations

Country	Name	City	State
United States	Scripps Translational Science Institute	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	Aetna, Inc., Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	End of 4 month monitoring period
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.	1 year