Virtual for Care Atrial Fibrillation Patients Using VIRTUES

NCT04599114 | Unknown

• 1 other identifier: 4411
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Atrial Fibrillation

Keywords

Virtual care

Outcome Measures

Primary Outcomes (1)

• Number of patients who present to the emergency department due to atrial fibrillation, after their index visit

  See title

  12 months

Secondary Outcomes (6)

• Number of AF-related ER visit per patient, post index visit

  12 months

• Utility of the system

  12 months

• Survey-based experience with the VIRTUES application

  Baseline, 3 months, 12 months

• Pre and post patient reported outcomes using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire and the EQ-5D-5L

  Baseline, 3 months, 12 months

• Time to stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death

  12 months

Study Arms (1)

VIRTUES Arm

EXPERIMENTAL

Patients in the VIRTUES arm will be offered enrollment into the virtual atrial fibrillation care platform.

Behavioral: VIRTUES

Interventions

VIRTUES BEHAVIORAL

VIRTUES is a digital health platform that offers 2 way communication between clinicians and patients to address symptoms stemming from atrial fibrillation.

VIRTUES Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Cardiac Arrhythmia Network of Canada: collaborator

Study Sites (3)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Rachel Caris

London, Ontario, N6A 5A5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Allan C Skanes, Md

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel A Caris, BScN

CONTACT

5196858500; rachel.caris@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Electrophysiology Laboratory

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 22, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)