HEARTS in Sync + CardioWatch 287-2

Health Behaviour Change, Education on Risk Factor Reduction, Physical Activity Guidance, and Nutrition Counselling With a Remote Team to Support Patient Progress Using Technology in Synchronization With Medication Management and CardioWatch 287-2. (HEARTS in Sync + CardioWatch 287-2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Disease; ASCVD Management; CHF - Congestive Heart Failure; Wearable Device
• Intervention / Treatment: Device: Remote Patient Monitoring with Corsano CardioWatch 287-2

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin N Welsh, PhD; Phone Number: 9027170603; Email: erin.welsh@nshealth.ca
• Study Contact Backup: Name: Brittany L Bhatnagar, MSc; Phone Number: 5062320947; Email: brittanyl.bhatnagar@nshealth.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3L4P1
      • Mumford Professional Centre
      • Contact: Wanda Firth; Phone Number: 9024733846; Email: wanda.firth@nshealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Cardiac Rehab + Corsano CardioWatch 287-2

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: High compliance: ≥ 50% daily wear time (~12 hours/day on all 7 days/week); Moderate compliance: ≥ 25% daily wear time (~6 hours/day); 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and In-Person Patients	Change in Metabolic Equivalents measured during the baseline exercise stress test and discharge stress test.	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	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 In-Person Patients	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 In-Person Patients	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 In-Person Patients	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 In-Person Patients	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 In-Person Patients	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)
Change in Triglyceride Level Change Between Device Users and In-Person Patients	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 In-Person Patients	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 In-Person Patients	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 In-Person Patients	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 In-Person Patients	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 In-Person Patients	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 In-Person Patients	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 In-Person Patients	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)

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: Corsano Health B.V.
• Investigators: Principal Investigator: Nicholas B Giacomantonio, Medical Doctor, Nova Scotia Health Authority

Publications and helpful links

General Publications

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• Brouwers RWM, van Exel HJ, van Hal JMC, Jorstad HT, de Kluiver EP, Kraaijenhagen RA, Kuijpers PMJC, van der Linde MR, Spee RF, Sunamura M, Uszko-Lencer NHMK, Vromen T, Wittekoek ME, Kemps HMC; Committee for Cardiovascular Prevention and Cardiac Rehabilitation of the Netherlands Society of Cardiology. Cardiac telerehabilitation as an alternative to centre-based cardiac rehabilitation. Neth Heart J. 2020 Sep;28(9):443-451. doi: 10.1007/s12471-020-01432-y.
• Lear SA. The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. Can J Cardiol. 2018 Oct;34(10 Suppl 2):S278-S283. doi: 10.1016/j.cjca.2018.07.009. Epub 2018 Jul 18.
• Bayoumy K, Gaber M, Elshafeey A, Mhaimeed O, Dineen EH, Marvel FA, Martin SS, Muse ED, Turakhia MP, Tarakji KG, Elshazly MB. Smart wearable devices in cardiovascular care: where we are and how to move forward. Nat Rev Cardiol. 2021 Aug;18(8):581-599. doi: 10.1038/s41569-021-00522-7. Epub 2021 Mar 4.
• Blok S, Piek MA, Tulevski II, Somsen GA, Winter MM. The accuracy of heartbeat detection using photoplethysmography technology in cardiac patients. J Electrocardiol. 2021 Jul-Aug;67:148-157. doi: 10.1016/j.jelectrocard.2021.06.009. Epub 2021 Jul 2.
• Corsano Health BV. CardioWatch 287-2 Bracelet & Mobile Patient App Instruction Manual.; 2024. www.corsano.com
• van Vliet M, Monnink SHJ, Kuiper MJ, Constandse JC, Hoftijzer D, Ronner E. Evaluation of a novel cuffless photoplethysmography-based wristband for measuring blood pressure according to the regulatory standards. Eur Heart J Digit Health. 2024 Feb 8;5(3):335-343. doi: 10.1093/ehjdh/ztae006. eCollection 2024 May.
• Monnink SHJ, van Vliet M, Kuiper MJ, Constandse JC, Hoftijzer D, Muller M, Ronner E. Clinical evaluation of a smart wristband for monitoring oxygen saturation, pulse rate, and respiratory rate. J Clin Monit Comput. 2025 Apr;39(2):451-457. doi: 10.1007/s10877-024-01229-z. Epub 2024 Oct 10.
• Stas P. Corsano Health Receives EU-MDR Certification. https://corsano.com/corsano-health-receives-eu-mdr-certification/.
• Verhaar C. Corsano Health Receives FDA Clearance. https://corsano.com/28091-2/.
• van Deudekom T. Corsano Health Receives ISO 13485 Certification. https://corsano.com/medical-certification/.
• Jones AK, Yan CL, Rivera Rodriquez BP, Kaur S, Andrade-Bucknor S. Role of wearable devices in cardiac telerehabilitation: A scoping review. PLoS One. 2023 May 31;18(5):e0285801. doi: 10.1371/journal.pone.0285801. eCollection 2023.
• Yeghiazarians Y, Jneid H, Tietjens JR, Redline S, Brown DL, El-Sherif N, Mehra R, Bozkurt B, Ndumele CE, Somers VK. Obstructive Sleep Apnea and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021 Jul 20;144(3):e56-e67. doi: 10.1161/CIR.0000000000000988. Epub 2021 Jun 21.
• Cheung C. The Emerging Role of Wearables in Cardiac Care. Vol 100.; 2023.
• Pare G, Leaver C, Bourget C. Diffusion of the Digital Health Self-Tracking Movement in Canada: Results of a National Survey. J Med Internet Res. 2018 May 2;20(5):e177. doi: 10.2196/jmir.9388.
• Lam J, Ahmad K, Gin K, Chow CM. Deliver Cardiac Virtual Care: A Primer for Cardiovascular Professionals in Canada. CJC Open. 2022 Feb;4(2):148-157. doi: 10.1016/j.cjco.2021.10.001. Epub 2021 Oct 9.
• 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.
• Moulson N, Bewick D, Selway T, Harris J, Suskin N, Oh P, Coutinho T, Singh G, Chow CM, Clarke B, Cowan S, Fordyce CB, Fournier A, Gin K, Gupta A, Hardiman S, Jackson S, Lamarche Y, Lau B, Legare JF, Leong-Poi H, Mansour S, Marelli A, Quraishi AUR, Roifman I, Ruel M, Sapp J, Small G, Turgeon R, Wood DA, Zieroth S, Virani S, Krahn AD. Cardiac Rehabilitation During the COVID-19 Era: Guidance on Implementing Virtual Care. Can J Cardiol. 2020 Aug;36(8):1317-1321. doi: 10.1016/j.cjca.2020.06.006. Epub 2020 Jun 14.
• 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.
• Thomas RJ, Beatty AL, Beckie TM, Brewer LC, Brown TM, Forman DE, Franklin BA, Keteyian SJ, Kitzman DW, Regensteiner JG, Sanderson BK, Whooley MA. Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. J Am Coll Cardiol. 2019 Jul 9;74(1):133-153. doi: 10.1016/j.jacc.2019.03.008. Epub 2019 May 13.
• Scherrenberg M, Wilhelm M, Hansen D, Voller H, Cornelissen V, Frederix I, Kemps H, Dendale P. The future is now: a call for action for cardiac telerehabilitation in the COVID-19 pandemic from the secondary prevention and rehabilitation section of the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2021 May 14;28(5):524-540. doi: 10.1177/2047487320939671.
• Santiago de Araujo Pio C, Beckie TM, Varnfield M, Sarrafzadegan N, Babu AS, Baidya S, Buckley J, Chen SY, Gagliardi A, Heine M, Khiong JS, Mola A, Radi B, Supervia M, Trani MR, Abreu A, Sawdon JA, Moffatt PD, Grace SL. Promoting patient utilization of outpatient cardiac rehabilitation: A joint International Council and Canadian Association of Cardiovascular Prevention and Rehabilitation position statement. Int J Cardiol. 2020 Jan 1;298:1-7. doi: 10.1016/j.ijcard.2019.06.064. Epub 2019 Jul 4.
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• Owen O, O'Carroll V. The effectiveness of cardiac telerehabilitation in comparison to centre-based cardiac rehabilitation programmes: A literature review. J Telemed Telecare. 2024 May;30(4):631-646. doi: 10.1177/1357633X221085865. Epub 2022 Apr 4.
• Grace SL, Turk-Adawi K, Santiago de Araujo Pio C, Alter DA. Ensuring Cardiac Rehabilitation Access for the Majority of Those in Need: A Call to Action for Canada. Can J Cardiol. 2016 Oct;32(10 Suppl 2):S358-S364. doi: 10.1016/j.cjca.2016.07.001. Epub 2016 Jul 9.
• Jamal Z, Horn R, Ager A. Effect of contributing factors on the incidence of non-communicable diseases among adults with common mental health disorders: a systematic review [Internet]. Southampton (UK): National Institute for Health and Care Research; 2024 May 22. Available from http://www.ncbi.nlm.nih.gov/books/NBK612376/
• Mizuno A, Changolkar S, Patel MS. Wearable Devices to Monitor and Reduce the Risk of Cardiovascular Disease: Evidence and Opportunities. Annu Rev Med. 2021 Jan 27;72:459-471. doi: 10.1146/annurev-med-050919-031534. Epub 2020 Sep 4.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: wearable device; remote monitoring; virtual cardiac rehabilitation
• Additional Relevant MeSH Terms: Heart Diseases; Heart Failure; Cardiovascular Diseases
• Other Study ID Numbers: REB File No. 1032019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No