Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05452356

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location status: Recruiting

Location contact

Kamkar

CONTACT

[email protected]

519-661-2111 ext. 86461

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Qualitative Outcomes from Focus Groups.

    Time frame: 1-Month.

    Emerging themes on VIRTUES features to improve and modify.

Secondary outcomes

  1. Physician Adherence to Guideline-Directed Recommendations (success is treated as ≥80%).

    Time frame: 1-Month.

    % of physicians who adhere to the recommendations.

  2. Patient Self-Reported Improvements in Parameters Specific to Each Module's Condition (success is treated as ≥80%).

    Time frame: 1-Month.

    % of patients who self-report an improvement in the condition specific to their module.

Other outcomes

  1. VIRTUES Application Reliability (for all reliability outcomes, success is treated as ≤20% disruptions or technical support requests).

    Time frame: 1-Month

    % of system disruptions over the 1-month trial use period and % of technical support requests over the 1-month trial use period.

  2. Number of Adverse Events

    Time frame: 1-Month.

    % of patients who experience an adverse event that is related to their participation.

Study contacts

Contact information is provided by the study sponsor or research team.

Nellie Kamkar, MSc

CONTACT

[email protected]

5196612111 ext. 86013

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Cardiac Arrhythmia Network of Canada

Registry information

Official study title

Testing of Patient Care Sets and Management of Cardiovascular Conditions Using a Virtual Platform

Acronym: VIRTUES-CC

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 11, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.