Virtual for Care Atrial Fibrillation Patients Using VIRTUES

NCT ID: NCT04599114

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2024-11-01

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

VIRTUES Arm

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

Group Type: EXPERIMENTAL

VIRTUES

Intervention Type: BEHAVIORAL

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

Interventions

VIRTUES

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiac Arrhythmia Network of Canada

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Allan Skanes

Director, Electrophysiology Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allan C Skanes, Md

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Rachel Caris

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Rachel A Caris, BScN

Role: CONTACT

rachel.caris@lhsc.on.ca

5196858500 ext. 32835

Facility Contacts

Ratika Parkash, MD

Role: primary

902-473-2700

Dana Murray, BScN

Role: primary

416-480-6100 ext. 1994

Other Identifiers

4411

Identifier Type: -

Identifier Source: org_study_id