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Virtual for Care Atrial Fibrillation Patients Using VIRTUES

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
VIRTUES
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atrial Fibrillation focused on measuring Virtual care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Elizabeth II Health Sciences Centre
  • Rachel Caris
  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VIRTUES Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of AF-related ER visit per patient, post index visit
See title
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
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.
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.
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.
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.

Full Information

First Posted
October 2, 2020
Last Updated
October 21, 2020
Sponsor
Lawson Health Research Institute
Collaborators
Cardiac Arrhythmia Network of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04599114
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Cardiac Arrhythmia Network of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Virtual care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VIRTUES Arm
Arm Type
Experimental
Arm Description
Patients in the VIRTUES arm will be offered enrollment into the virtual atrial fibrillation care platform.
Intervention Type
Behavioral
Intervention Name(s)
VIRTUES
Intervention Description
VIRTUES is a digital health platform that offers 2 way communication between clinicians and patients to address symptoms stemming from atrial fibrillation.
Primary Outcome Measure Information:
Title
Number of patients who present to the emergency department due to atrial fibrillation, after their index visit
Description
See title
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of AF-related ER visit per patient, post index visit
Description
See title
Time Frame
12 months
Title
Utility of the system
Description
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
Time Frame
12 months
Title
Survey-based experience with the VIRTUES application
Description
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.
Time Frame
Baseline, 3 months, 12 months
Title
Pre and post patient reported outcomes using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire and the EQ-5D-5L
Description
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.
Time Frame
Baseline, 3 months, 12 months
Title
Time to stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death
Description
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.
Time Frame
12 months
Title
Frequency of stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death
Description
The number of any of the above conditions occurring in both the retrospective and prospective cohorts will be counted and analyzed.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel A Caris, BScN
Phone
5196858500
Ext
32835
Email
rachel.caris@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan C Skanes, Md
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ratika Parkash, MD
Phone
902-473-2700
First Name & Middle Initial & Last Name & Degree
Ratika Parkash, MD
Facility Name
Rachel Caris
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Murray, BScN
Phone
416-480-6100
Ext
1994
First Name & Middle Initial & Last Name & Degree
Benedict Glover, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual for Care Atrial Fibrillation Patients Using VIRTUES

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