Atrial FibrillationNCT05900414
RAPID AFib Decision Aid for Stroke Prevention in Atrial Fibrillation
A study testing Electronic patient decision aid and Information in people with Atrial Fibrillation, run by University of Calgary at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Electronic patient decision aid and Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Apr 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Joel Adekanye, MPH contact
Canada2 sites, 2 recruiting
- Recruiting
Calgary Zone, Alberta Health Services
Calgary, Alberta, T2N 2T9
Stephen Wilton, MD, 403-210-7102, sbwilton@ucalgary.ca
Joel Adekanye, MD, joel.adekanye@ucalgary.ca
- Recruiting
Vita Diagnostics
Calgary, Alberta, T2W 3M6
Lou Kolman, MD, 587-393-8482, louis.kolman@ahs.ca
About this study
Official title: 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.
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.
Read the detailed description
Background:
Atrial fibrillation (AF) leads to a 4-fold increased risk of stroke, accounting for 15-20% of the 50,000 strokes suffered by Canadians each year. The annual stroke risk in untreated patients is 4.5%, but varies 10-fold based on risk factors captured in clinical prediction tools. Given that oral anticoagulation (OAC) reduces stroke risk by 65%, the majority of AF-associated strokes are potentially preventable. All current Canadian and international AF guidelines strongly recommend use of clinical prediction rules to assess stroke risk, and anticoagulation of high-risk patients. However, population-based studies continue to document significant rates of risk-discordant stroke prevention therapy. Addressing this care gap is a major knowledge translation challenge.
Patient decision aids are knowledge translation tools that can facilitate a process of shared decision-making to improve patient knowledge and decision quality. These tools have the potential to improve both initial therapy selection and adherence, ultimately reducing the risks of AF-associated stroke and unnecessary bleeding. We have developed and performed initial user testing for a new, web-based decision aid, called Risk Assessment and Personal preferences to Improve Decisions for Atrial Fibrillation (RAPID AFib). The tool has 3 sequential functions: (1) it estimates an individual's risk for stroke and for bleeding using published risk scores; (2) it allows them to interactively compare OACs to select one or more therapies that best matches their risk profile and individual preferences ; and (3) it summarizes the risk information and their selected therapy to facilitate discussion with their physician in a Summary Report. This study represents the next step in this program of research, by performing a formal evaluation of the performance of this tool in a real-world clinical setting.
Primary Objective:
To conduct a pilot study to establish the acceptability of the RAPID AFib tool and its impact on the process of shared decision-making for stroke prevention therapy in patients with recent onset AF
Hypothesis:
The RAPID Afib decision aid will be acceptable for both patients and clinicians, and will lead to more effective shared decision-making than standard care among patients with AF who are considering OAC.
Methods:
Study Design: Prospective, randomized pilot study.
Study procedures:
Clinic staff will screen referred patients, then the research team will approach them to confirm eligibility, request informed consent for participation, and collect baseline demographic and clinical data. Consenting patients will be randomized 1:1 using a web-based application linked to the study database to receive the study intervention or control. Randomization will be stratified by clinic site.
All patients will be invited to review an evidence-based website providing information about AF and its management.
Intervention group: Patients randomized to the RAPID AFib intervention will be sent a link to the decision aid website and asked to complete the decision aid before their upcoming visit. They will also be asked to bring the Summary Report to their upcoming clinic visit. A copy of the Summary Report will be added to the patient chart for clinician review.
Control group: Patients randomized to the control group will attend their clinic visit as scheduled, with no further direction from the study team.
Follow-up: Study participation will end after completion of a post-visit survey.
- Conditions
- Atrial Fibrillation
- Being tested
- Electronic patient decision aid, Information
- Keywords
- patient decision aid, stroke, shared decision aid, anticoagulant therapy
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic patient decision aidBehavioural
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
InformationOther
Link to website with information about atrial fibrillation treatments
| Study group | Role | What they receive |
|---|---|---|
| Patient Decision Aid | Experimental | Receives web-based information and access to patient decision aid before clinic visit Receives: Behavioral: Electronic patient decision aid |
| Control | Active comparator | Receives web-based information only before clinic visit Receives: Other: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Apr 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Principal investigator, Stephen B. Wilton, University of Calgary
- Investigators
- Stephen B Wilton, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900414
- Sponsor's protocol ID
- REB22-1737
- Status last verified
- Mar 2025
- First submitted
- 4 Jun 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make individual patient data available to external researchers from this pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05900414
- Acronym / sponsor ID
- REB22-1737
- Conditions
- Atrial Fibrillation
- Keywords
- patient decision aid, stroke, shared decision aid, anticoagulant therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Servier
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Atrial fibrillation (AF) leads to a 4-fold increased risk of stroke, accounting for 15-20% of the 50,000 strokes suffered by Canadians each year. The annual stroke risk in untreated patients is 4.5%, but varies 10-fold based on risk factors captured in clinical prediction tools. Given that oral anticoagulation (OAC) reduces stroke risk by 65%, the majority of AF-associated strokes are potentially preventable. All current Canadian and international AF guidelines strongly recommend use of clinical prediction rules to assess stroke risk, and anticoagulation of high-risk patients. However, population-based studies continue to document significant rates of risk-discordant stroke prevention therapy. Addressing this care gap is a major knowledge translation challenge.
Patient decision aids are knowledge translation tools that can facilitate a process of shared decision-making to improve patient knowledge and decision quality. These tools have the potential to improve both initial therapy selection and adherence, ultimately reducing the risks of AF-associated stroke and unnecessary bleeding. We have developed and performed initial user testing for a new, web-based decision aid, called Risk Assessment and Personal preferences to Improve Decisions for Atrial Fibrillation (RAPID AFib). The tool has 3 sequential functions: (1) it estimates an individual's risk for stroke and for bleeding using published risk scores; (2) it allows them to interactively compare OACs to select one or more therapies that best matches their risk profile and individual preferences ; and (3) it summarizes the risk information and their selected therapy to facilitate discussion with their physician in a Summary Report. This study represents the next step in this program of research, by performing a formal evaluation of the performance of this tool in a real-world clinical setting.
Primary Objective:
To conduct a pilot study to establish the acceptability of the RAPID AFib tool and its impact on the process of shared decision-making for stroke prevention therapy in patients with recent onset AF
Hypothesis:
The RAPID Afib decision aid will be acceptable for both patients and clinicians, and will lead to more effective shared decision-making than standard care among patients with AF who are considering OAC.
Methods:
Study Design: Prospective, randomized pilot study.
Study procedures:
Clinic staff will screen referred patients, then the research team will approach them to confirm eligibility, request informed consent for participation, and collect baseline demographic and clinical data. Consenting patients will be randomized 1:1 using a web-based application linked to the study database to receive the study intervention or control. Randomization will be stratified by clinic site.
All patients will be invited to review an evidence-based website providing information about AF and its management.
Intervention group: Patients randomized to the RAPID AFib intervention will be sent a link to the decision aid website and asked to complete the decision aid before their upcoming visit. They will also be asked to bring the Summary Report to their upcoming clinic visit. A copy of the Summary Report will be added to the patient chart for clinician review.
Control group: Patients randomized to the control group will attend their clinic visit as scheduled, with no further direction from the study team.
Follow-up: Study participation will end after completion of a post-visit survey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Decision Aid | Experimental | Behavioral: Electronic patient decision aidReceives web-based information and access to patient decision aid before clinic visit |
| Control | Active comparator | Other: InformationReceives web-based information only before clinic visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic patient decision aidLink 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 | Behavioural | Patient Decision Aid |
| InformationLink to website with information about atrial fibrillation treatments | Other | Control |
Primary outcome
The 9-Item Shared Decision Making Questionnaire (SDM-Q-9: patient version).
Time frame: Immediately after clinic visit
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No. We do not plan to make individual patient data available to external researchers from this pilot study.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joel Adekanye, MPH contact
Stephen B Wilton, MD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic patient decision aid and Information in people with Atrial Fibrillation, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen B Wilton, MD (403-210-7102, sbwilton@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 9-Item Shared Decision Making Questionnaire (SDM-Q-9: patient version). (time frame: Immediately after clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.