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

NCT05452356 | Recruiting

• 1 other identifier: 12505
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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. 1.antithrombotic management
2. 2.lipid management
3. 3.rate and rhythm control for atrial fibrillation
4. 4.heart failure care
5. 5.post myocardial infarction care
6. 6.blood sugar management
7. 7.blood pressure management
8. 8.physical activity
9. 9.healthy eating
10. 10.smoking cessation
11. 11.alcohol reduction

Conditions

Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Cardiovascular Diseases; Pathologic Processes

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  1-Month.

• Qualitative Outcomes from Focus Groups.

  Emerging themes on VIRTUES features to improve and modify.

  1-Month.

Secondary Outcomes (2)

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

  1-Month.

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

  1-Month.

Other Outcomes (2)

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

  1-Month

• Number of Adverse Events

  1-Month.

Eligibility Criteria

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

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).

You may qualify if:

• 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.

You may not qualify if:

• Any medical condition making 1-month survival unlikely.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Cardiac Arrhythmia Network of Canada: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Cardiovascular Diseases; Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony Tang, MD FRCPC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nellie Kamkar, MSc

CONTACT

5196612111; Nellie.Kamkar@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: April 18, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-03

Locations

CA (1)