Computer Simulated Atrial Fibrillation Tool

NCT03080857 | Completed

• 1 other identifier: RP-003
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a before-after study, using a prospective cohort to evaluate the use of a virtual, patient-centered platform as compared to a historical cohort of patients with atrial fibrillation (AF) and if the education and support provided by the platform will reduce Emergency Department visits for AF.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Feasibility of using the simulated AF clinic platform

  Assessing the percentage of patients who utilize the virtual patient platform on a regular basis to guide their management. A successful pilot will be defined as: 90% of patients use the platform at least once, 75% of patients use it at least twice over the six month follow up period.

  6 months

Secondary Outcomes (1)

• Patient satisfaction

  6 months

Study Arms (1)

Virtual Platform

EXPERIMENTAL

Patients will be provided with a computer simulated tool to assist with education and support relating to atrial fibrillation.

Other: Virtual Platform; Device: AliveCor Heart Monitor

Interventions

Virtual Platform OTHER

The platform will direct patients to review the Canadian Cardiovascular Guidelines and the Heart \& Stroke website for commonly asked questions relating to atrial fibrillation, as well as recommendations regarding nutrition and activity.

Also known as: Computer simulated atrial fibrillation tool (CSAF Tool)

Virtual Platform

AliveCor Heart Monitor DEVICE

A substudy of patients enrolled into the CSAF Tool study who own a compatible smart phone will be randomized to the Alive Cor Heart Monitor plus the virtual platform versus the virtual platform alone. The purpose of this substudy is to assess the feasibility and effect of incorporating Alive COR into a virtual online patient-education platform on patients' quality of life and AF-related emergency room visits and hospitalizations.

Virtual Platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• can ambulate independently
• provide informed consent
• have documented symptomatic AF
• are proficient in the English language
• have access to a computer, tablet or smartphone

You may not qualify if:

• unable to participate due to physical limitations
• are planning to move during the period of study
• have a medical condition making 1 year survival unlikely.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Cardiac Arrhythmia Network of Canada: collaborator

Study Sites (1)

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ratika Parkash, MD FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Model Details: Cohort study to assess a computer simulated electronic platform

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 15, 2017
• Study Start: May 15, 2018
• Primary Completion: December 31, 2019
• Study Completion: May 31, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)