NCT03860246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

February 14, 2019

Last Update Submit

February 28, 2019

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • atrial fibrillation

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

    30 days

Interventions

Portable ECG monitorDIAGNOSTIC_TEST

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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

nursing home residents

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CTRC

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne B Curtis, MD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SUNY Distinguished Professor

Study Record Dates

First Submitted

February 14, 2019

First Posted

March 1, 2019

Study Start

February 1, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

March 4, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)