CompletedNot Applicable

mHealth Screening to Prevent Strokes

United States6,135 participantsStarted 2015-11

Plain-language 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.

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group

Timeframe: End of 4 month monitoring period

Trial details

NCT IDNCT02506244

SponsorScripps Translational Science Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09

Results submitted2022-05-04

View on ClinicalTrials.gov More Atrial Fibrillation trials