Atrial Fibrillation Screening in Nursing Homes

Atrial Fibrillation Clinical Trial

Official title:

Screening for Atrial Fibrillation in High-Risk Nursing Home Residents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860246
• Other study ID #: STUDY00001737
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: February 2019
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Portable ECG monitor
Recording of ECG rhythm on a portable monitor (Kardia Mobile)

Locations

Country	Name	City	State
United States	CTRC	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	atrial fibrillation	number of participants with atrial fibrillation on any of four rhythm recordings	30 days