Clinical trial NCT04599114: Virtual for Care Atrial Fibrillation Patients Using VIRTUES
Official title: Virtual for Care Atrial Fibrillation Patients Using VIRTUES (Virtual Integrated Reliable Transformative User-Driven E-Health System)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Virtual care
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Cardiac Arrhythmia Network of Canada
First posted: 2020-10-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will use a retrospective chart review to examine characteristics of patients who present to the emergency room with atrial fibrillation as well as a non-randomized prospective cohort who will be offered enrollment into the virtual platform.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients will atrial fibrillation, a type of irregular heart rhythm, frequently go to the emergency room in order to manage their condition. This study will use a chart review to look at the characteristics and frequency of atrial fibrillation patients who go to the emergency room. In addition to the chart review, patients with atrial fibrillation who have recently gone to the emergency room or have been hospitalized will be approached and asked if they want to use an electronic health care system that can be accessed by both themselves and their health care providers. Along with the system, patients will be given a Health Canada approved heart rhythm sensor, so patients will be able to record their heart rhythm when they feel symptoms and send the information to the heart rhythm team. The heart rhythm team will then make real-time recommendations to the patient about how they can manage their rhythm and symptoms. Patients will be asked to complete satisfaction and quality of life surveys. Our goal is to provide efficient and effective care for patients with AF, resulting in decreased repeat ED visits.

Detailed description: See brief summary.

Eligibility criteria: Inclusion Criteria:

* able to provide informed consent
* documented symptomatic new-onset or pre-existing, non-valvular AF
* ER visit or hospitalization for primary AF in the last 6 months
* proficient in the English language

Exclusion Criteria:

* unable to provide informed consent
* planning to move/relocate during the period of study
* current pregnancy
* patient is a prisoner/incarcerated
* no access to a smart device with Bluetooth capabilities
* planned percutaneous coronary intervention, coronary artery bypass graphing or heart valve surgery within the next year
* any medical condition making 1 year survival unlikely

Primary outcomes:
measure: Number of patients who present to the emergency department due to atrial fibrillation, after their index visit
timeFrame: 12 months
Secondary outcomes:
measure: Number of AF-related ER visit per patient, post index visit
timeFrame: 12 months
measure: Utility of the system
timeFrame: 12 months
measure: Survey-based experience with the VIRTUES application
timeFrame: Baseline, 3 months, 12 months
measure: Pre and post patient reported outcomes using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire and the EQ-5D-5L
timeFrame: Baseline, 3 months, 12 months
measure: Time to stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death
timeFrame: 12 months
measure: Frequency of stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death
timeFrame: 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: Rachel Caris
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Allan C Skanes, Md
role: PRINCIPAL_INVESTIGATOR
References: