Electronic decision aid for stroke prevention in atrial fibrillation
Pilot Clinical Trial of the Risk Assessment and Personal Preference to Improve Decisions in Atrial Fibrillation Patient Decision Aid for Stroke Prevention in Atrial Fibrillation: the RAPID AFib Pilot Trial.
This study is testing a new electronic tool to help people with atrial fibrillation make better choices about stroke prevention treatments before their doctor visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT05900414 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates a new electronic patient decision aid designed to enhance shared decision-making for stroke prevention in patients with atrial fibrillation. Participants, diagnosed with atrial fibrillation within the last year, will receive either standard educational materials or the decision aid alongside these materials before their specialist visit. The study aims to determine the acceptability of the decision aid and its effectiveness in improving decision quality compared to standard care. By facilitating better understanding and choices regarding anticoagulant therapy, the trial seeks to address gaps in stroke prevention strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with a recent diagnosis of non-valvular atrial fibrillation and no prior anticoagulant treatment or treatment for less than 90 days.
Not a fit: Patients with valvular atrial fibrillation or those currently on dual antiplatelet therapy for reasons other than atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve patient understanding and adherence to stroke prevention therapies, potentially reducing the incidence of AF-associated strokes.
How similar studies have performed: Other studies have shown promise in using patient decision aids for improving shared decision-making in various medical contexts, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non-valvular AF diagnosed within 12 months, with any level of stroke risk assessed by CHA2DS2-VASc score. * Age 18 or older * Either no OAC treatment or treated for less than 90 days. * Initial specialist AF visit scheduled in 7-30 days. Exclusion Criteria: * Valvular AF, defined, per Canadian Cardiovascular Society Guidelines, as AF in the presence of mechanical heart valves, rheumatic mitral stenosis, or moderate to severe nonrheumatic mitral stenosis. * Currently prescribed dual antiplatelet therapy (ASA plus either clopidogrel, ticagrelor, or prasugrel) for an indication other than AF. * Has an independent, non-AF indication for oral anticoagulation. * Has a non-modifiable impediment to effective use of web-based tools. Examples include lack of internet access, lack of English literacy (Grade 5 level).
Where this trial is running
Calgary, Alberta and 1 other locations
- Calgary Zone, Alberta Health Services — Calgary, Alberta, Canada (Recruiting)
- Vita Diagnostics — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Stephen B Wilton, MD — University of Calgary
- Study coordinator: Stephen B Wilton, MD
- Email: sbwilton@ucalgary.ca
- Phone: 403-210-7102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.