Clinical trial NCT05452356: Testing VIRTUES Patient Care Sets in Cardiac Patients (VIRTUES Cardiac Care)
Official title: Testing of Patient Care Sets and Management of Cardiovascular Conditions Using a Virtual Platform
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Diseases
Arrhythmias, Cardiac
Atrial Fibrillation
Cardiovascular Diseases
Pathologic Processes
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Cardiac Arrhythmia Network of Canada
First posted: 2022-07-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 pilot trial. 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).

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 application.

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 trial to determine which modules apply to them, and they will be given a survey on their experience using VIRTUES after approximately 2 weeks of using it, and again after approximately one-month of using VIRTUES. Patients will also be given an opportunity to volunteer for a virtual focus group discussion with other patients. The goal of this pilot study is to provide insights on how to modify and improve VIRTUES based on patient feedback.

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.

Primary outcomes:
measure: Patient Application Utilization (success is treated as ≥80% on each of the sub-items).
timeFrame: 1-Month.
measure: Patient Access to Care (success is treated as ≥80% on each of the sub-items).
timeFrame: 1-Month.
measure: Patient Autonomy (success is treated as ≥80%).
timeFrame: 1-Month.
measure: Patient Recommendation Adherence (success is treated as ≥80%).
timeFrame: 1-Month.
measure: Patient Overall Satisfaction (success is treated as ≥80%).
timeFrame: 1-Month.
measure: Qualitative Outcomes from Focus Groups.
timeFrame: 1-Month.
Secondary outcomes:
measure: Physician Adherence to Guideline-Directed Recommendations (success is treated as ≥80%).
timeFrame: 1-Month.
measure: Patient Self-Reported Improvements in Parameters Specific to Each Module's Condition (success is treated as ≥80%).
timeFrame: 1-Month.
Other outcomes:
measure: VIRTUES Application Reliability (for all reliability outcomes, success is treated as ≤20% disruptions or technical support requests).
timeFrame: 1-Month
measure: Number of Adverse Events
timeFrame: 1-Month.
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Anthony Tang, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: