Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05900414

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electronic patient decision aid

Information

Study Details

Brief summary:

The goal of this pilot clinical trial is to evaluate the utility of a new electronic patient decision aid for stroke prevention therapy in patients with atrial fibrillation. The main questions it aims to answer are:

Is the patient decision aid acceptable to both patients and physicians? Does the patient decision aid lead to more effective shared decision-making than standard care among patients with atrial fibrillation who are considering stroke prevention therapy? Participants with a recent diagnosis of atrial fibrillation will be enrolled before an upcoming specialist physician visit. Researchers will compare a pre-visit intervention consisting of standard educational materials plus use of the patient decision aid to educational materials alone to see if using the decision aid results in improved shared decision making during the clinic visit.

Conditions

Atrial Fibrillation

Study ID

NCT05900414

Start date

Apr 1, 2024

Status verified date

Mar, 2025

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Patient Decision Aid

Receives web-based information and access to patient decision aid before clinic visit

active comparator: Control

Receives web-based information only before clinic visit

Interventions

Electronic patient decision aid

Link to website with information about atrial fibrillation treatments, plus access to the web-based patient decision aid to enable shared decision making between patients and their physicians for atrial fibrillation stroke prevention treatments

Information

Link to website with information about atrial fibrillation treatments

Primary outcome measure

  • The 9-Item Shared Decision Making Questionnaire (SDM-Q-9: patient version). [ Time Frame: Immediately after clinic visit ]

Central Contacts and Locations

Central contacts

Stephen B Wilton, MD

403-210-7102sbwilton@ucalgary.ca

Joel Adekanye, MPH

joel.adekanye@ucalgary.ca

Locations

Calgary Zone, Alberta Health Services

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Stephen Wilton, MD

403-210-7102sbwilton@ucalgary.ca

Joel Adekanye, MD

joel.adekanye@ucalgary.ca

Vita Diagnostics

Recruiting

Calgary, Alberta, Canada, T2W 3M6

Contacts

Lou Kolman, MD

587-393-8482louis.kolman@ahs.ca

More Information

Sponsor

University of Calgary

Last update posted

Apr 2, 2025

Last verified

Mar, 2025

Keywords

  • patient decision aid
  • stroke
  • shared decision aid
  • anticoagulant therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2025-04-02.