Clinical trial NCT03080857: Computer Simulated Atrial Fibrillation Tool
Official title: Computer Simulated Atrial Fibrillation Tool to Reduce Hospitalizations and Emergency Department Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Cardiac Arrhythmia Network of Canada
First posted: 2017-03-15
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort study to assess a computer simulated electronic platform
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Feasibility of using the simulated AF clinic platform
timeFrame: 6 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QE II Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Ratika Parkash, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: