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

Cardiovascular Diseases Clinical Trial

— VIRTUES-CC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05452356
• Other study ID #: 12505
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: Lawson Health Research Institute
• Contact: Nellie Kamkar, MSc
• Phone: 5196612111
• Email: Nellie.Kamkar[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1400
• Est. completion date: December 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Cardiac Arrhythmia Network of Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	1-Month
Other	Number of Adverse Events	% of patients who experience an adverse event that is related to their participation.	1-Month.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Qualitative Outcomes from Focus Groups.	Emerging themes on VIRTUES features to improve and modify.	1-Month.
Secondary	Physician Adherence to Guideline-Directed Recommendations (success is treated as =80%).	% of physicians who adhere to the recommendations.	1-Month.
Secondary	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.	1-Month.