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OpenTrials
Completed

NCT Number: NCT02506244

mHealth Screening to Prevent Strokes

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Translational Science Institute

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iRhythm ZIO XT Patch

Device

Single-lead ECG monitoring via a wearable patch

Wristband by Amiigo

Device

Determines pulse rate using photoplethysmography.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Collaborators

  • Aetna, Inc.
  • Janssen Scientific Affairs, LLC

Registry information

Official study title

mHealth Screening to Prevent Strokes (mSToPS)

Acronym: mSToPS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2015
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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