N/A
Completed N=6,135
mHealth Screening to Prevent Strokes
Source: ClinicalTrials.gov NCT02506244 ↗Enrolled (actual)
6,135
Serious AEs
—
Results posted
Dec 2022
Primary outcomePrimary: Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group — 53; 12 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group |
53; 12 | — |
| SECONDARY Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls |
63; 46; 81 | — |
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
Data sourced from ClinicalTrials.gov (NCT02506244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.