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| Name | Class |
|---|---|
| Corsano Health B.V. | INDUSTRY |
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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:
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.
Compare clinical outcomes between users and non-users of the device within the HEARTS in Sync program, by:
Asses the feasibility of the CardioWatch 287-2 for the HEARTS in Sync virtual CR program by:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Cardiac Rehab + Corsano CardioWatch 287-2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Phones that are not compatible with the Corsano system.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin N Welsh, PhD | Contact | 9027170603 | erin.welsh@nshealth.ca | |
| Brittany L Bhatnagar, MSc | Contact | 5062320947 | brittanyl.bhatnagar@nshealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Nicholas B Giacomantonio, Medical Doctor | Nova Scotia Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mumford Professional Centre | Halifax | Nova Scotia | B3L4P1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Corsano Health BV. CardioWatch 287-2 Bracelet & Mobile Patient App Instruction Manual.; 2024. www.corsano.com | ||
| 38774367 | Background | 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. | |
| 34256184 |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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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.
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|
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:
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) |
| 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) |
| Background |
| 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. |
| 39388061 | Background | 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. |
| Background | Stas P. Corsano Health Receives EU-MDR Certification. https://corsano.com/corsano-health-receives-eu-mdr-certification/. |
| Background | Verhaar C. Corsano Health Receives FDA Clearance. https://corsano.com/28091-2/. |
| Background | van Deudekom T. Corsano Health Receives ISO 13485 Certification. https://corsano.com/medical-certification/. |
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