VIRTUES-CC: Testing VIRTUES Patient Care Sets in Cardiac Patients (VIRTUES Cardiac Care)

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05452356
Collaborator
Cardiac Arrhythmia Network of Canada (Other)
550
16

Study Details

Study Description

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 mobile 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: Blood Thinning, Post Heart Attack Care, Rate and Rhythm Control, Lipid Management, Blood Pressure Management, Physical Activity, Healthy Eating, Blood Sugar Management, Smoking Cessation, Alcohol Reduction, and Heart Failure Care. In this pilot study, the investigators will test each module with 50 patients for a month 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 for cardiac patients.

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 Cardiac Arrhythmia Network of Canada (CANet). VIRTUES is a downloadable mobile phone application using built-in algorithms specific to each patient to make guideline-directed recommendations to patients and their healthcare providers and provide educational material. VIRTUES includes the following 11 targeted modules: Blood Thinning, Post Heart Attack Care, Rate and Rhythm Control, Lipid Management, Blood Pressure Management, Physical Activity, Healthy Eating, Blood Sugar Management, Smoking Cessation, Alcohol Reduction, and Heart Failure Care. The current pilot study tests the feasibility, usability, and patient experience of using VIRTUES. Each patient will only be exposed to module(s) specific to her/his condition. Each of the 11 modules will be tested for one month with approximately 50 patients. Patients will complete a survey 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 2 weeks of using it, and after the one-month trial. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
550 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Testing of Patient Care Sets and Management of Cardiovascular Conditions Using a Virtual Platform
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Patient Application Utilization (success is treated as ≥80% on each of the sub-items). [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). [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%). [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%). [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%). [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. [1-Month.]

    Emerging themes on VIRTUES features to improve and modify.

Secondary Outcome Measures

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

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

Other Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lawson Health Research Institute
  • Cardiac Arrhythmia Network of Canada

Investigators

  • Principal Investigator: Allan Skanes, MD FRCPC, London Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT05452356
Other Study ID Numbers:
  • 12505
First Posted:
Jul 11, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022