Virtual for Care Atrial Fibrillation Patients Using VIRTUES

Virtual for Care Atrial Fibrillation Patients Using VIRTUES (Virtual Integrated Reliable Transformative User-Driven E-Health System)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Behavioral: VIRTUES

Detailed Description

See brief summary.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel A Caris, BScN; Phone Number: 32835 5196858500; Email: rachel.caris@lhsc.on.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth Ii Health Sciences Centre
      • Contact: Ratika Parkash, MD; Phone Number: 902-473-2700
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Rachel Caris
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
      • Contact: Dana Murray, BScN; Phone Number: 1994 416-480-6100
      • Principal Investigator: Benedict Glover, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIRTUES Arm; Patients in the VIRTUES arm will be offered enrollment into the virtual atrial fibrillation care platform.	Behavioral: VIRTUES; VIRTUES is a digital health platform that offers 2 way communication between clinicians and patients to address symptoms stemming from atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who present to the emergency department due to atrial fibrillation, after their index visit	See title	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of AF-related ER visit per patient, post index visit	See title	12 months
Utility of the system	Number of uses of the system/patient, number of accesses to the health record, number of heart rhythm VIRTUES team - patient feedbacks on the VIRTUES app, percentage of care plans followed by the patient	12 months
Survey-based experience with the VIRTUES application	Survey-based experience will be determined by the "Virtual AF Care Patient Satisfaction Questionnaire". The questionnaire consists of 5 questions regarding the VIRTUES platform using a 5 point likert scale (strongly agree to strongly disagree) in addition to a final open ended question asking for feedback regarding the 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	The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire is a well-validated questionnaire with 2 sections. The first section asked about a patient's incidence of atrial fibrillation, the second section inquires as to the presence of atrial fibrillation symptomsand how limiting they were. In general, higher scores mean more frequent atrial fibrillation symptoms that are very/extremely limiting and bothersome.	Baseline, 3 months, 12 months
Time to stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death	The length of time between index presentation for atrial fibrillation and the onset of any of the above conditions will be calculated for both the retrospective and prospective cohorts.	12 months
Frequency of stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death	The number of any of the above conditions occurring in both the retrospective and prospective cohorts will be counted and analyzed.	12 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Cardiac Arrhythmia Network of Canada
• Investigators: Principal Investigator: Allan C Skanes, Md, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Virtual care
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 4411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No