RAPID AFib Decision Aid for Stroke Prevention in Atrial Fibrillation

NCT05900414 | Recruiting

• 1 other identifier: REB22-1737
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

patient decision aid; stroke; shared decision aid; anticoagulant therapy

Outcome Measures

Primary Outcomes (1)

• The 9-Item Shared Decision Making Questionnaire (SDM-Q-9: patient version).

  The SDM-Q-9 is a reliable, brief and well accepted instrument for measuring shared decision-making process from the patient's perspective. The statements can be rated on a 6-point scale ranging from completely disagree (0) to completely agree (5). The addition of these scores for the 9 items will result in a score between 0 and 45. The raw score (over 45) can be converted to an equivalent number between 0 and 100 by multiplying by 20/9. 0 represents the lowest possible level of SDM while 100 corresponds to highest level of SDM.

  Immediately after clinic visit

Other Outcomes (5)

• OPTION 5: Objective assessment of shared decision-making

  Immediately after clinic visit

• Physician version of the 9-Item Shared Decision Making Questionnaire (SDM-Q-Doc)

  Immediately after clinic visit

• Therapy decision

  Immediately after clinic visit

Study Arms (2)

Patient Decision Aid

EXPERIMENTAL

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

Behavioral: Electronic patient decision aid

Control

ACTIVE COMPARATOR

Receives web-based information only before clinic visit

Other: Information

Interventions

Electronic patient decision aid BEHAVIORAL

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

Patient Decision Aid

Information OTHER

Link to website with information about atrial fibrillation treatments

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Calgary: lead
• Servier: collaborator

Study Sites (2)

Calgary Zone, Alberta Health Services

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Vita Diagnostics

Calgary, Alberta, T2W 3M6, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Stephen B Wilton, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen B Wilton, MD

CONTACT

403-210-7102; sbwilton@ucalgary.ca

Joel Adekanye, MPH

CONTACT

joel.adekanye@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Cardiac Sciences

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 12, 2023
• Study Start: April 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)