Remote Monitoring for Cardiovascular Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this interventional study is to evaluate the implementation, usability, and clinical outcomes of a wearable medical-grade device in a virtual Cardiac Rehabilitation (CR) program, titled HEARTS in Sync. The question guiding this study is: Do patient clinical outcomes differ between those who use the CardioWatch 287-2 during the HEARTS in Sync program as compared to those who participate without using the CardioWatch 287-2? The comparison will happen between two non-randomized groups of patients who are enrolled in the HEARTS in Sync virtual CR program.
The wearable device (CardioWatch 287-2), worn on patient's wrists, will provide clinicians with physiological information to better mirror the clinical oversight provided to an in-person CR program. Participants who choose to use the device will be asked to wear it daily. The clinical team will review weekly summary reports to help guide participant progress through the 13-week program.
The primary objectives of this study are to:
1. Characterize participants (e.g., demographic health history, patient feedback) between those who choose to use the CardioWatch 287-2 device and those who do not.
2. Compare clinical outcomes between users and non-users of the device within the HEARTS in Sync program, by:
1. Tracking patient enrollment, attendance in virtual education sessions, and program completion rates,
2. Evaluating change in patient bloodwork outcomes,
3. Measuring change is physical ability,
4. Analyzing changes in eating behaviours, and
5. Examining quality of life using validated tools.
3. Asses the feasibility of the CardioWatch 287-2 for the HEARTS in Sync virtual CR program by:
1. Assessing device adherence
2. Reviewing patient feedback survey, and
3. Determining if clinician team were able to access and interpret data collected throughout the program
The secondary objective of this study is to compare clinical outcomes of device users during the HEARTS in Sync program with patients who completed the on-site CR program.
This research aims to better understand how a medical-grade device may improve virtual CR programming to extend clinical care to the community. As a result, this could lead to a more personalized care and better results for patients.
Who Is on the Research Team?
Nicholas B Giacomantonio, Medical Doctor
Principal Investigator
Nova Scotia Health Authority
Are You a Good Fit for This Trial?
This trial is for patients in Nova Scotia who qualify for cardiac rehab and are enrolling in the HEARTS in Sync virtual program. It's not specified who can't join, but typically those not meeting CR criteria would be excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in a 13-week virtual Cardiac Rehabilitation program, with or without the CardioWatch 287-2 device
Follow-up
Participants are monitored for changes in clinical outcomes and quality of life after program completion
What Are the Treatments Tested in This Trial?
Interventions
- Corsano CardioWatch 287-2
Trial Overview
The study tests if using the CardioWatch 287-2 wearable device affects clinical outcomes of patients in a virtual Cardiac Rehabilitation (CR) program compared to those without it. The device provides physiological data to clinicians over a 13-week course.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nova Scotia Health Authority
Lead Sponsor
Corsano Health B.V.
Industry Sponsor
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