Testing VIRTUES Patient Care Sets in Cardiac Patients (VIRTUES Cardiac Care)

NCT ID: NCT05452356

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-18
• Study Completion Date: 2028-09-30

Brief 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. 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:

1. antithrombotic management

2. lipid management

3. rate and rhythm control for atrial fibrillation

4. heart failure care

5. post myocardial infarction care

6. blood sugar management

7. blood pressure management

8. physical activity

9. healthy eating

10. smoking cessation

11. 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:

1. antithrombotic management

2. lipid management

3. rate and rhythm control for atrial fibrillation

4. heart failure care

5. post myocardial infarction care

6. blood sugar management

7. blood pressure management

8. physical activity

9. healthy eating

10. smoking cessation

11. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Any medical condition making 1-month survival unlikely.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiac Arrhythmia Network of Canada

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Tang, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Nellie Kamkar, MSc

Role: CONTACT

Nellie.Kamkar@lhsc.on.ca

5196612111 ext. 86013

Facility Contacts

Kamkar

Role: primary

Nellie.Kamkar@lhsc.on.ca

519-661-2111 ext. 86461

Other Identifiers

12505

Identifier Type: -

Identifier Source: org_study_id