HEARTS in Sync + CardioWatch 287-2

Summary

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.

Conditions

• Wearable Device
• Cardiovascular Disease
• ASCVD Management
• CHF - Congestive Heart Failure

Interventions

DEVICE

Remote Patient Monitoring with Corsano CardioWatch 287-2

Participants wear a CardioWatch 287-2 during the 13-week virtual cardiac rehabilitation program, HEARTS in Sync. The program is delivered by the Nova Scotia Health clinical team that consists of a Registered Nurse, Registered Dietitian and Physiotherapist. The CardioWatch 287-2 collects health information such as pulse rate, blood pressure, sleep, steps, activity, and more. This information is available for participants to check on the patient app called "Corsano". The information is also summarized on a weekly report that reports 7-day average which the clinical team will review on the Healthcare Practitioner web-based portal. This information is used to guide the participants rehabilitation journey. These participants will be followed to understand program adherence, patient-reported usability and acceptability, and clinical outcomes collected at baseline and program discharge.

Sponsors & Collaborators

• Corsano Health B.V.

  collaborator INDUSTRY

• Nova Scotia Health Authority

  lead OTHER

Principal Investigators

• Nicholas B Giacomantonio, Medical Doctor · Nova Scotia Health Authority

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-28

Primary Completion

2028-02-29

Completion

2029-02-28

Countries

• Canada

Study Locations