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Atrial FibrillationNCT03080857

Computer Simulated Atrial Fibrillation Tool

A study testing Virtual Platform and AliveCor Heart Monitor in people with Atrial Fibrillation, run by Nova Scotia Health Authority at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Virtual Platform and AliveCor Heart Monitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteCanada
Study dates
15 May 2018to 31 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • QE II Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

Other trials in Canada

About this study

Official title: Computer Simulated Atrial Fibrillation Tool to Reduce Hospitalizations and Emergency Department Visits

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.

Read the 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.

Being tested
Virtual Platform, AliveCor Heart Monitor
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual PlatformOther

    Also called Computer simulated atrial fibrillation tool (CSAF Tool)

    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.

  • AliveCor Heart MonitorDevice

    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.

Study groups in NCT03080857
Study groupRoleWhat they receive
Virtual PlatformExperimentalPatients will be provided with a computer simulated tool to assist with education and support relating to atrial fibrillation.
Receives: Other: Virtual Platform; Device: AliveCor Heart Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (1)
  1. Patient satisfaction

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2017
  2. Study start15 May 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Cohort study to assess a computer simulated electronic platform
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080857
Sponsor's protocol ID
RP-003
Status last verified
Jul 2020
First submitted
9 Mar 2017
Last updated
22 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Platform and AliveCor Heart Monitor in people with Atrial Fibrillation, run by Nova Scotia Health Authority at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of using the simulated AF clinic platform (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.

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