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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Any medical condition making 1-month survival unlikely.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
1-Month.
2

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.

Time frame
1-Month.
3

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.

Time frame
1-Month.
4

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.

Time frame
1-Month.

Secondary outcomes

1

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

% of physicians who adhere to the recommendations.

Time frame
1-Month.
2

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.

Time frame
1-Month.

Other outcomes

1

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

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

Time frame
1-Month
2

Number of Adverse Events

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

Time frame
1-Month.

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