Atrial Fibrillation Screening in Nursing Homes

NCT ID: NCT03860246

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 245 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-11-01

Brief Summary

This study was designed to screen high risk patients in nursing homes for atrial fibrillation with intermittent electrocardiogram (ECG) recordings using a portable, smartphone-based, mobile ECG recording device (Kardia Mobile, AliveCor, Inc.). The investigators hypothesized that screening patients with 2 or more risk factors for atrial fibrillation would yield a higher incidence of atrial fibrillation compared to prior studies.

Detailed Description

This is a prospective study that enrolled 245 residents from 15 participating nursing homes with ≥2 risk factors for atrial fibrillation. All residents gave informed consent or had a legally appointed representative who could consent on their behalf. Exclusion criteria included residents with a prior diagnosis of atrial fibrillation, continuous rhythm monitoring over the past year, and pacemaker or implantable cardioverter defibrillator in situ.

Screening was performed using the smartphone-based, mobile ECG recording device. Thirty second rhythm recordings were obtained on each resident on four different occasions within a month. All tracings were reviewed by a cardiologist and, in the case of any uncertainty, the diagnosis of atrial fibrillation was confirmed by an electrophysiologist. When atrial fibrillation was detected in a resident (primary endpoint), no further rhythm recordings were performed and the resident's nursing facility was then notified of the diagnosis. Further evaluation and treatment were directed by the resident's primary care physician.

All data were stored on a secure encrypted server with password protection. The investigators used chi-square and t-test analyses to determine if there were significant differences in demographic variables or risk factors for atrial fibrillation between residents with and without atrial fibrillation. Logistic regression analysis determined if any combination of risk factors was predictive of a positive atrial fibrillation screen.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Portable ECG monitor

Recording of ECG rhythm on a portable monitor (Kardia Mobile)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Nursing home residents with ≥2 of the following risk factors for atrial fibrillation:

• age ≥75 years
• female sex
• obstructive sleep apnea
• peripheral vascular disease
• diabetes mellitus
• obesity (body mass index [BMI] >30 kg/m2)
• hypertension
• congestive heart failure

Exclusion Criteria

• prior diagnosis of AF
• continuous rhythm monitoring over the past year
• pacemaker or implantable cardioverter defibrillator in situ

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Anne Curtis

SUNY Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne B Curtis, MD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

CTRC

Buffalo, New York, United States

Countries

United States

Other Identifiers

STUDY00001737

Identifier Type: -

Identifier Source: org_study_id