- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03080857
Computer Simulated Atrial Fibrillation Tool
Computer Simulated Atrial Fibrillation Tool to Reduce Hospitalizations and Emergency Department Visits
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 3A7
- QE II Health Sciences Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Virtual Platform
Patients will be provided with a computer simulated tool to assist with education and support relating to atrial fibrillation.
|
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.
Andra namn:
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Feasibility of using the simulated AF clinic platform
Tidsram: 6 months
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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.
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6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Patient satisfaction
Tidsram: 6 months
|
Semi-quantitative data will be collected regarding patient satisfaction with the platform.
|
6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ratika Parkash, MD FRCPC, Nova Scotia Health Authority
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RP-003
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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