HEARTS in Sync + CardioWatch 287-2

NCT07322510 | Not Yet Recruiting

• 1 other identifier: REB File No. 1032019
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Compare clinical outcomes between users and non-users of the device within the HEARTS in Sync program, by:
3. 3.Tracking patient enrollment, attendance in virtual education sessions, and program completion rates,
4. 4.Evaluating change in patient bloodwork outcomes,
5. 5.Measuring change is physical ability,
6. 6.Analyzing changes in eating behaviours, and
7. 7.Examining quality of life using validated tools.
8. 8.Asses the feasibility of the CardioWatch 287-2 for the HEARTS in Sync virtual CR program by:
9. 9.Assessing device adherence
10. 10.Reviewing patient feedback survey, and
11. 11.Determining if clinician team were able to access and interpret data collected throughout the program

Conditions

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

Keywords

virtual cardiac rehabilitation; wearable device; remote monitoring

Outcome Measures

Primary Outcomes (20)

• Patient Program Adherence

  The proportion (%) of program sessions attended by each patient, comparing device users and non-device user. Attendance percentage will be obtained by program records.

  From enrollment to 13-week program completion

• Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and Non-Device Users

  Change in Metabolic Equivalents measured during the baseline exercise stress test and discharge stress test.

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

• Change in Fat Intake Score Between Device Users and Non-Device Users

  Change in patient fat intake score measured using a validated nutrition questionnaire at baseline and discharge.

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

• Change in Fibre Intake Score Between Device Users and Non-Device Users

  Change in patient fibre intake score measured using a validated nutrition questionnaire at baseline and discharge.

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

• Change in Sodium Intake Score Between Device Users and Non-Device Users

  Change in patient sodium intake score measured using a validated nutrition questionnaire at baseline and discharge.

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

• Change in Sugar Intake Score Between Device Users and Non-Device Users

  Change in patient fat intake score measured using a validated nutrition questionnaire at baseline and discharge.

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

• Change in Quality of Life Ladder Score Between Device Users and Non-Device Users

  Examine change in patient-reported quality of life using the Quality of Life Ladder at initial/baseline and discharge report.

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

• Change in Satisfaction with Life Between Device Users and Non-Device Users

  Examine change in patient-reported quality of life using the Satisfaction with Life Scale at initial/baseline and discharge report.

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

• Characterize Participants

  Determine demographic and health history between device users and non-device users

  Initial (at assessment)

• Device Adherence to Wearing the CardioWatch 287-2

  Device adherence will be assessed by calculating the proportion of total study days during which each participant wore the device for the required monitoring duration. Adherence will be categorized into one of the three following groups: 1. High compliance: ≥ 50% daily wear time (\~12 hours/day on all 7 days/week) 2. Moderate compliance: ≥ 25% daily wear time (\~6 hours/day) 3. Low compliance: ≥ 12.5% daily wear time (\~3 hours/day) The unit of measure is percentage (%) of days with required wear time and proportion (%) of participants in each adherence category. Device adherence is automatically captured through the Corsano CardioWatch 287-2 system.

  From enrollment to the end of the program at 13-weeks

• Patient-Reported Usability and Acceptability of the CardioWatch 287-2

  Participants' perceptions of usability, comfort, and acceptability of the device will be assessed using a study-specific questionnaire that includes both participant rating scale and free-text responses. Only the ranked items will be used for quantitative outcome reporting while the free-text responses will be summarized descriptively.

  After completion of the program (e.g. after 13 weeks)

• Clinician-Reported Usability of the CardioWatch 287-2 System

  Clinicians' assessment of device usability including ease of data interpretation, integration into clinical workflow, and perceived clinical value. This will be a descriptive analysis only captured through a study-specific focus group.

  Up to 1 year after study completion

• Change in Triglyceride Level Change Between Device Users and Non-Device Users

  Triglycerides (mmol/L) will be measured via standard blood panel.

  Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)

• Change in Total Cholesterol Level Change Between Device Users and Non-Device Users

  Total cholesterol (mmol/L) will be measured via lipid panel in bloodwork.

  Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)

• Change in HDL Cholesterol Level Change Between Device Users and Non-Device Users

  HDL cholesterol (mmol/L) will be measured via lipid panel in bloodwork.

  Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)

• Change in LDL Cholesterol Level Change Between Device Users and Non-Device Users

  LDL cholesterol (mmol/L) will be measured via lipid panel in bloodwork.

  Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)

• Change in Hemoglobin A1C Level Change Between Device Users and Non-Device Users

  HbA1C (%) will be measured via standard bloodwork.

  Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)

• Change in Systolic Blood Pressure Between Device Users and Non-Device Users

  Systolic blood pressure (mmHg) measured by a blood pressure monitor.

  Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)

• Change in Diastolic Blood Pressure Between Device Users and Non-Device Users

  Diastolic blood pressure (mmHg) measured by a blood pressure monitor.

  Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)

• Change in Resting Heart Rate between Device Users and Non-Device Users

  Resting heart rate (beats per minute) will be measured at assessment and near end of program completion

  Initial (at assessment) and Discharge (near end of program completion, up to 6 weeks after program completion)

Secondary Outcomes (15)

• Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and In-Person Patients

  Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)

• Change in Fat Intake Score Between Device Users and In-Person Patients

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

• Change in Fibre Intake Score Between Device Users and In-Person Patients

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

• Change in Sodium Intake Score Between Device Users and In-Person Patients

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

• Change in Sugar Intake Score Between Device Users and In-Person Patients

  Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)

Study Arms (1)

Virtual Cardiac Rehab + Corsano CardioWatch 287-2

EXPERIMENTAL

Device: Remote Patient Monitoring with Corsano CardioWatch 287-2

Interventions

Remote Patient Monitoring with Corsano CardioWatch 287-2 DEVICE

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.

Virtual Cardiac Rehab + Corsano CardioWatch 287-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Corsano Health B.V.: collaborator

Study Sites (1)

Mumford Professional Centre

Halifax, Nova Scotia, B3L4P1, Canada

Location

Related Publications (27)

• Corsano Health BV. CardioWatch 287-2 Bracelet & Mobile Patient App Instruction Manual.; 2024. www.corsano.com

  BACKGROUND

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• van Deudekom T. Corsano Health Receives ISO 13485 Certification. https://corsano.com/medical-certification/.

  BACKGROUND

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  PMID: 33664502 BACKGROUND

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  PMID: 30274638 BACKGROUND

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  PMID: 34661090 BACKGROUND

• Ramachandran HJ, Jiang Y, Tam WWS, Yeo TJ, Wang W. Effectiveness of home-based cardiac telerehabilitation as an alternative to Phase 2 cardiac rehabilitation of coronary heart disease: a systematic review and meta-analysis. Eur J Prev Cardiol. 2022 May 25;29(7):1017-1043. doi: 10.1093/eurjpc/zwab106.

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• Dalal HM, Doherty P, McDonagh ST, Paul K, Taylor RS. Virtual and in-person cardiac rehabilitation. BMJ. 2021 Jun 3;373:n1270. doi: 10.1136/bmj.n1270. No abstract available.

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MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Nicholas B Giacomantonio, Medical Doctor

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin N Welsh, PhD

CONTACT

9027170603; erin.welsh@nshealth.ca

Brittany L Bhatnagar, MSc

CONTACT

5062320947; brittanyl.bhatnagar@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director - REDUCE-IT, Cardiologist

Model Details: Participants enrolled in HEARTS in Sync program who use the Corsano CardioWatch 287-2 will be followed to evaluate the implementation and usability of the device into routine virtual cardiac rehabilitation care, as well as associated health outcomes. The health outcomes from participants in the clinical trial will be compared to two external control groups. First external control group consists of patients who are enrolled in usual care, virtual cardiac rehab program without the Corsano CardioWatch 287-2 device. The second external control group consists of patients who completed an on-site cardiac rehabilitation program. Both external control groups sign a program consent form that allows their data to be used for research purposes. This design allows for assessment of the device integration into usual care and its impact on patient outcomes in a real-world setting.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 7, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)