Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
216 participants
INTERVENTIONAL
2026-02-28
2029-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
This design allows for assessment of the device integration into usual care and its impact on patient outcomes in a real-world setting.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Virtual Cardiac Rehab + Corsano CardioWatch 287-2
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.
Interventions
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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.
Eligibility Criteria
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Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Corsano Health B.V.
INDUSTRY
Nova Scotia Health Authority
OTHER
Responsible Party
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Nicholas Giacomantonio
Medical Director - REDUCE-IT, Cardiologist
Principal Investigators
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Nicholas B Giacomantonio, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health Authority
Locations
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Mumford Professional Centre
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Grace SL, Bennett S, Ardern CI, Clark AM. Cardiac rehabilitation series: Canada. Prog Cardiovasc Dis. 2014 Mar-Apr;56(5):530-5. doi: 10.1016/j.pcad.2013.09.010. Epub 2013 Oct 11.
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/
Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
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.
Other Identifiers
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REB File No. 1032019
Identifier Type: -
Identifier Source: org_study_id
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