HEARTS in Sync + CardioWatch 287-2

Nova Scotia Health Authority (NSHA)

Status: Not yet enrolling

Conditions: ASCVD Management; CHF - Congestive Heart Failure; Wearable Device; Cardiovascular Disease

Treatments: Device: Remote Patient Monitoring with Corsano CardioWatch 287-2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07322510

REB File No. 1032019

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who meet CR inclusion criteria requirements and who are enrolling in virtual cardiac rehab program, HEARTS in Sync, in Nova Scotia.

Exclusion criteria

Phones that are not compatible with the Corsano system.

• Huawei P8 Lite
• Huawei P9 Lite
• Xiaomi Mi 6
• Huawei P20 Lite
• Apple iOS version lower than 14.5
• Android OS version lower than 8.0
• Android or Apple devices without Bluetooth® 5.0 Low Energy capability

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

216 participants in 1 patient group

Virtual Cardiac Rehab + Corsano CardioWatch 287-2

Experimental group

Treatment:

Device: Remote Patient Monitoring with Corsano CardioWatch 287-2