search
Back to results

Computer Simulated Atrial Fibrillation Tool

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Platform
AliveCor Heart Monitor
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • QE II Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Platform

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient satisfaction
Semi-quantitative data will be collected regarding patient satisfaction with the platform.

Full Information

First Posted
March 9, 2017
Last Updated
July 20, 2020
Sponsor
Nova Scotia Health Authority
Collaborators
Cardiac Arrhythmia Network of Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT03080857
Brief Title
Computer Simulated Atrial Fibrillation Tool
Official Title
Computer Simulated Atrial Fibrillation Tool to Reduce Hospitalizations and Emergency Department Visits
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
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
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.
Detailed Description
Atrial fibrillation (AF) is the most common sustained arrhythmia affecting 1-2% of the population of the western world, increasing to 10% in patients above the age of 75. The lifetime risk for development of AF is 26% for men and 23% for women. It is associated with significant morbidity, mortality and cost, but also with a two-fold increase in mortality and a six-fold risk of stroke. Severity of symptoms for AF may range from a 'nuisance' feeling of palpitations to debilitating symptoms that affect quality of life, interfere with normal livelihood and significantly impair exercise tolerance to more severe symptoms (hemodynamic compromise and heart failure), which are associated with poor prognosis and increased mortality. Patients who are symptomatic pose the greatest burden to the health care system, often making repeated visits to the emergency room for treatment or repeated hospitalizations. AF is known to be a chronic disease. The majority of patients have progressively more episodes of AF, or present with persistent AF. As with all chronic diseases, it cannot be cured but can be controlled with effective treatments. AF often occurs in the setting of other diseases, increasing the complexity in determining appropriate therapies. Most often, AF occurs in the setting of other cardiovascular disease, obesity, diabetes, sleep apnea or a combination of the above. In order to effectively manage AF, a 'holistic' approach is necessary. Appropriate management of hypertension, sleep apnea, obesity, etc. is part of the mainstay of therapy for AF. This is part of the Canadian Cardiovascular Society (CCS) AF guidelines recommendations stating: "underlying causes or precipitating factors for AF including hypertension should be identified and treated". Current guidelines suggest that AF treatment should focus on strategies to manage and control heart rate and rhythm. Exercise and physical activity have been shown to improve outcomes in patients with some cardiac conditions (ischemic heart disease, myocardial infarction, congestive heart failure), but its effects on AF are still not clear. The current Canadian health care system was designed to address acute illness, rather than chronic disease, which is impacting hospitalizations for symptomatic AF. There is not an AF clinic at the QEII Health Sciences Centre to assist with AF management after a patient has been seen by a specialist. The investigators propose to create, evaluate, refine and implement a virtual, patient-centered platform to guide patients with out-of-hospital management of atrial fibrillation, after evaluation by a specialist.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort study to assess a computer simulated electronic platform
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Platform
Arm Type
Experimental
Arm Description
Patients will be provided with a computer simulated tool to assist with education and support relating to atrial fibrillation.
Intervention Type
Other
Intervention Name(s)
Virtual Platform
Other Intervention Name(s)
Computer simulated atrial fibrillation tool (CSAF Tool)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AliveCor Heart Monitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of using the simulated AF clinic platform
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Semi-quantitative data will be collected regarding patient satisfaction with the platform.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: can ambulate independently provide informed consent have documented symptomatic AF are proficient in the English language have access to a computer, tablet or smartphone Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ratika Parkash, MD FRCPC
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
QE II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Computer Simulated Atrial Fibrillation Tool

We'll reach out to this number within 24 hrs