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OpenTrials
Completed

NCT Number: NCT03860246

Atrial Fibrillation Screening in Nursing Homes

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CTRC

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

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

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

Treatment and study plan

Portable ECG monitor

Diagnostic Test

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

Primary outcomes

  1. atrial fibrillation

    Time frame: 30 days

    number of participants with atrial fibrillation on any of four rhythm recordings

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

Screening for Atrial Fibrillation in High-Risk Nursing Home Residents

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2019
Registry last updated
Mar 4, 2019

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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