Virtual for Care Atrial Fibrillation Patients Using VIRTUES

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04599114
• Other study ID #: 4411
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2020
• Source: Lawson Health Research Institute
• Contact: Rachel A Caris, BScN
• Phone: 5196858500
• Email: rachel.caris[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See brief summary.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Rachel Caris	London	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Cardiac Arrhythmia Network of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who present to the emergency department due to atrial fibrillation, after their index visit	See title	12 months
Secondary	Number of AF-related ER visit per patient, post index visit	See title	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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