Virtual for Care Atrial Fibrillation Patients Using VIRTUES | NCT04599114

Studies
Virtual for Care Atrial Fibrillation Patients Using VIRTUES

NCT04599114

Sponsor

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

Status

Unknown status

Last Update Posted

Oct 22, 2020Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

VIRTUES

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Estimated

Primary Completion Date

Nov 1, 2023Estimated

Completion Date

Nov 1, 2024Estimated

First Submitted Date

Oct 2, 2020

First Submission Date that Met QC Criteria

Oct 21, 2020

First Posted Date

Oct 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2020

Last Update Posted Date

Oct 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Allan Skanes, Director, Electrophysiology Laboratory, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Cardiac Arrhythmia Network of Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VIRTUES Arm	Experimental	Patients in the VIRTUES arm will be offered enrollment into the virtual atrial fibrillation care platform.	Behavioral: VIRTUES

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rachel A Caris, BScN	Contact	5196858500	32835	rachel.caris@lhsc.on.ca

Overall Officials

Name	Affiliation	Role
Allan C Skanes, Md	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Elizabeth II Health Sciences Centre		Halifax	Nova Scotia	B3H 2Y9	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.