Heart DiseasesVIRTUES-CCNCT05452356
Testing VIRTUES Patient Care Sets in Cardiac Patients (VIRTUES Cardiac Care)
An observational study of Heart Diseases and Arrhythmias, Cardiac, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients with various cardiac conditions (such as those who experience a heart attack) are increasing in Canada and are in need of appropriate cardiac rehabilitation and care. Many patients do not have access to local in-person cardiac clinics, particularly in rural regions of Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases, Arrhythmias, Cardiac, Atrial Fibrillation
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2024to 30 Sep 2028
- Phase
- Observational
- 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
Study population: Patients will be recruited via emergency room (ER) visits, cardiac care unit (CCU) visits, and cardiac rehabilitation visits for any cardiac health problem over the course of the study. Cardiac conditions include the following: 1. Atrial Fibrillation (AF). 2. Atrial Flutter. 3. Prior Myocardial Infarction (Post MI). 4. Prior Coronary Artery Disease (CAD). 5. Prosthetic Heart Valve. 6. Dilated Aorta. 7. Carotid Artery Disease. 8. Peripheral Artery Disease. 9. Diabetes Mellitus (DM). 10. Hyperlipidemia (HLP). 11. Hypertension (HTN).
Who may be able to join
- Any patient with a cardiovascular condition.
- Ability to provide informed consent.
- Proficient in the English language.
- Access to a device capable of running mobile application.
- Used mobile technology within the past 3 months.
Who cannot join
- Any medical condition making 1-month survival unlikely.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre Research Institute
London, Ontario, N6A5A5
Allan Skanes, MD, FRCPC, FHRS, 519-685-8500 ext. 33746, Allan.Skanes@lhsc.on.ca
About this study
Official title: Testing of Patient Care Sets and Management of Cardiovascular Conditions Using a Virtual Platform
Patients with various cardiac conditions (such as those who experience a heart attack) are increasing in Canada and are in need of appropriate cardiac rehabilitation and care. Many patients do not have access to local in-person cardiac clinics, particularly in rural regions of Canada. A user-friendly digital application with accessible educational resources and recommendations based on the most up to date clinical practice guidelines can help mitigate these issues. VIRTUES is a digital healthcare application that targets 11 modifiable modules as follows:
- antithrombotic management
- lipid management
- rate and rhythm control for atrial fibrillation
- heart failure care
- post myocardial infarction care
- blood sugar management
- blood pressure management
- physical activity
- healthy eating
- smoking cessation
- alcohol reduction
Of the 11 total modules, the first 7 listed provide recommendations in VIRTUES. The remaining 4 (physical activity, healthy eating, smoking cessation and alcohol reduction) consist of simple referrals to existing recommendations (i.e., for healthy eating and physical exercise) and referrals to existing local programs (i.e., for smoking cessation and alcohol reduction). Thus, in this cohort study, the investigators will test the primary 7 modules with 200 patients per module for approximately one month each in order to obtain feedback on the usability of each module. The investigators will also conduct virtual focus group discussions to obtain open ended feedback on the application. This study will provide valuable feedback, which will be used to improve and adapt the VIRTUES platform.
Read the detailed description
Heart conditions are on the rise in Canada, contributing substantially to patient quality of life. For example, over 60,000 Canadians will experience a heart attack per year. Other conditions, such as Atrial Fibrillation (in which the heart beats rapidly and irregularly) are also highly prevalent, with an estimated 250% increase by 2050. Unfortunately, few patients receive appropriate cardiac rehabilitation, and local in-person cardiac clinics are often inaccessible in rural regions. Patients need user-friendly, accessible educational resources based on current clinical practice guidelines. A digital interphase where patients can access their health information easily, and receive accurate medical advice can significantly help them manage their conditions. VIRTUES ("Virtual Integrated Reliable Transformative User Driven E-Health System") is a digital healthcare platform developed in partnership with the Cardiovascular Network of Canada (CANet). VIRTUES is a web application that uses built-in algorithms specific to each patient to make guideline-directed recommendations to patients and their healthcare providers and provide individually tailored educational material. VIRTUES includes the following 11 targeted modules:
- antithrombotic management
- lipid management
- rate and rhythm control for atrial fibrillation
- heart failure care
- post myocardial infarction care
- blood sugar management
- blood pressure management
- physical activity
- healthy eating
- smoking cessation
- alcohol reduction
Of the 11 total modules, the first 7 listed provide recommendations to patients in VIRTUES. The remaining 4 (physical activity, healthy eating, smoking cessation and alcohol reduction) consist of simple referrals to existing local programs. The current cohort study tests the feasibility, usability, and patient experience of using VIRTUES in 200 patients across the 7 targeted modules that provide individually tailored recommendations. Each patient will only be exposed to module(s) specific to her/his condition. Testing will take place over the duration of approximately one month per module with approximately 1,400 patients in total (200 patients enrolled in each of the 7 modules). Patients will complete a series of forms assessing their medical history at the beginning of the study and they will be given a survey on their experience using VIRTUES after 6 and 12 months of using it. Patients will also be given an opportunity to volunteer for a virtual focus group discussion with other patients. The goal of this study is to provide insights on how to modify and improve VIRTUES based on patient feedback.
- Conditions
- Heart Diseases, Arrhythmias, Cardiac, Atrial Fibrillation, Cardiovascular Diseases, Pathologic Processes
- Medical subject headings
- Heart Diseases, Arrhythmias, Cardiac, Atrial Fibrillation, Cardiovascular Diseases, Pathologic Processes
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Application Utilization (success is treated as ≥80% on each of the sub-items).
% of patients who completed all tasks (i.e., blood pressure entry) required of their module, % of patients who completed all 3 surveys (baseline, mid-VIRTUES, post-VIRTUES), % of patients who viewed all educational material presented to them for their module, and number of interactions with VIRTUES per week across the month.
Measured: 1-Month.
Patient Access to Care (success is treated as ≥80% on each of the sub-items).
% of patients who self-report that the program facilitated their access to care and % of patients who self-report that the program created a higher quality of care for them.
Measured: 1-Month.
Patient Autonomy (success is treated as ≥80%).
% of patients who self-report that the program provided them with a greater sense of autonomy in their care.
Measured: 1-Month.
Patient Recommendation Adherence (success is treated as ≥80%).
% of patients who self-report that they have reviewed all guideline-directed recommendations given to them for their module with their healthcare provider.
Measured: 1-Month.
Patient Overall Satisfaction (success is treated as ≥80%).
% of patients who self-report that they are overall moderately to highly satisfied with the VIRTUES program.
Measured: 1-Month.
Qualitative Outcomes from Focus Groups.
Emerging themes on VIRTUES features to improve and modify.
Measured: 1-Month.
Secondary outcomes (2)
Physician Adherence to Guideline-Directed Recommendations (success is treated as ≥80%).
% of physicians who adhere to the recommendations.
Measured: 1-Month.
Patient Self-Reported Improvements in Parameters Specific to Each Module's Condition (success is treated as ≥80%).
% of patients who self-report an improvement in the condition specific to their module.
Measured: 1-Month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start18 Apr 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada
- Responsible party
- Sponsor
- Investigators
- Anthony Tang, MD FRCPC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452356
- Sponsor's protocol ID
- 12505
- Acronym
- VIRTUES-CC
- Status last verified
- May 2026
- First submitted
- 6 Jul 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of Patient Care Sets and Management of Cardiovascular Conditions Using a Virtual Platform
- ClinicalTrials.gov ID
- NCT05452356
- Acronym / sponsor ID
- VIRTUES-CC / 12505
- Conditions
- Heart Diseases, Arrhythmias, Cardiac, Atrial Fibrillation, Cardiovascular Diseases, Pathologic Processes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 11 Jul 2022 (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.
Patients with various cardiac conditions (such as those who experience a heart attack) are increasing in Canada and are in need of appropriate cardiac rehabilitation and care. Many patients do not have access to local in-person cardiac clinics, particularly in rural regions of Canada. A user-friendly digital application with accessible educational resources and recommendations based on the most up to date clinical practice guidelines can help mitigate these issues. VIRTUES is a digital healthcare application that targets 11 modifiable modules as follows:
- antithrombotic management
- lipid management
- rate and rhythm control for atrial fibrillation
- heart failure care
- post myocardial infarction care
- blood sugar management
- blood pressure management
- physical activity
- healthy eating
- smoking cessation
- alcohol reduction
Of the 11 total modules, the first 7 listed provide recommendations in VIRTUES. The remaining 4 (physical activity, healthy eating, smoking cessation and alcohol reduction) consist of simple referrals to existing recommendations (i.e., for healthy eating and physical exercise) and referrals to existing local programs (i.e., for smoking cessation and alcohol reduction). Thus, in this cohort study, the investigators will test the primary 7 modules with 200 patients per module for approximately one month each in order to obtain feedback on the usability of each module. The investigators will also conduct virtual focus group discussions to obtain open ended feedback on the application. This study will provide valuable feedback, which will be used to improve and adapt the VIRTUES platform.
Detailed description
Heart conditions are on the rise in Canada, contributing substantially to patient quality of life. For example, over 60,000 Canadians will experience a heart attack per year. Other conditions, such as Atrial Fibrillation (in which the heart beats rapidly and irregularly) are also highly prevalent, with an estimated 250% increase by 2050. Unfortunately, few patients receive appropriate cardiac rehabilitation, and local in-person cardiac clinics are often inaccessible in rural regions. Patients need user-friendly, accessible educational resources based on current clinical practice guidelines. A digital interphase where patients can access their health information easily, and receive accurate medical advice can significantly help them manage their conditions. VIRTUES ("Virtual Integrated Reliable Transformative User Driven E-Health System") is a digital healthcare platform developed in partnership with the Cardiovascular Network of Canada (CANet). VIRTUES is a web application that uses built-in algorithms specific to each patient to make guideline-directed recommendations to patients and their healthcare providers and provide individually tailored educational material. VIRTUES includes the following 11 targeted modules:
- antithrombotic management
- lipid management
- rate and rhythm control for atrial fibrillation
- heart failure care
- post myocardial infarction care
- blood sugar management
- blood pressure management
- physical activity
- healthy eating
- smoking cessation
- alcohol reduction
Of the 11 total modules, the first 7 listed provide recommendations to patients in VIRTUES. The remaining 4 (physical activity, healthy eating, smoking cessation and alcohol reduction) consist of simple referrals to existing local programs. The current cohort study tests the feasibility, usability, and patient experience of using VIRTUES in 200 patients across the 7 targeted modules that provide individually tailored recommendations. Each patient will only be exposed to module(s) specific to her/his condition. Testing will take place over the duration of approximately one month per module with approximately 1,400 patients in total (200 patients enrolled in each of the 7 modules). Patients will complete a series of forms assessing their medical history at the beginning of the study and they will be given a survey on their experience using VIRTUES after 6 and 12 months of using it. Patients will also be given an opportunity to volunteer for a virtual focus group discussion with other patients. The goal of this study is to provide insights on how to modify and improve VIRTUES based on patient feedback.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited via emergency room (ER) visits, cardiac care unit (CCU) visits, and cardiac rehabilitation visits for any cardiac health problem over the course of the study. Cardiac conditions include the following: 1. Atrial Fibrillation (AF). 2. Atrial Flutter. 3. Prior Myocardial Infarction (Post MI). 4. Prior Coronary Artery Disease (CAD). 5. Prosthetic Heart Valve. 6. Dilated Aorta. 7. Carotid Artery Disease. 8. Peripheral Artery Disease. 9. Diabetes Mellitus (DM). 10. Hyperlipidemia (HLP). 11. Hypertension (HTN).
Key inclusion criteria (5 listed)
- Any patient with a cardiovascular condition.
- Ability to provide informed consent.
- Proficient in the English language.
- Access to a device capable of running mobile application.
- Used mobile technology within the past 3 months.
Key exclusion criteria (1 listed)
- Any medical condition making 1-month survival unlikely.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Application Utilization (success is treated as ≥80% on each of the sub-items).
Time frame: 1-Month.
% of patients who completed all tasks (i.e., blood pressure entry) required of their module, % of patients who completed all 3 surveys (baseline, mid-VIRTUES, post-VIRTUES), % of patients who viewed all educational material presented to them for their module, and number of interactions with VIRTUES per week across the month.
Patient Access to Care (success is treated as ≥80% on each of the sub-items).
Time frame: 1-Month.
% of patients who self-report that the program facilitated their access to care and % of patients who self-report that the program created a higher quality of care for them.
Patient Autonomy (success is treated as ≥80%).
Time frame: 1-Month.
% of patients who self-report that the program provided them with a greater sense of autonomy in their care.
Patient Recommendation Adherence (success is treated as ≥80%).
Time frame: 1-Month.
% of patients who self-report that they have reviewed all guideline-directed recommendations given to them for their module with their healthcare provider.
Patient Overall Satisfaction (success is treated as ≥80%).
Time frame: 1-Month.
% of patients who self-report that they are overall moderately to highly satisfied with the VIRTUES program.
Qualitative Outcomes from Focus Groups.
Time frame: 1-Month.
Emerging themes on VIRTUES features to improve and modify.
2 secondary outcomes
Physician Adherence to Guideline-Directed Recommendations (success is treated as ≥80%).
Time frame: 1-Month.
Patient Self-Reported Improvements in Parameters Specific to Each Module's Condition (success is treated as ≥80%).
Time frame: 1-Month.
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 13 Aug 2026.
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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.
Anthony Tang, MD FRCPC principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Arrhythmias, Cardiac, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site 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 5 inclusion and 1 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Nellie Tang, MD, FRCPC (519-685-8500 ext. 33746, Anthony.Tang@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Application Utilization (success is treated as ≥80% on each of the sub-items). (time frame: 1-Month.). The study lists 6 primary outcomes in all. 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 13 Aug 2026.