HEARTS in Sync + CardioWatch 287-2

Официальное название

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)

Обзор

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.

Вмешательства

• Устройство 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 summa

Первичные конечные точки

• Patient Program Adherence [Срок оценки: From enrollment to 13-week program completion]
• Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and Non-Device Users [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)]
• Characterize Participants [Срок оценки: Initial (at assessment)]
• Device Adherence to Wearing the CardioWatch 287-2 [Срок оценки: From enrollment to the end of the program at 13-weeks]

Вторичные конечные точки (12)

• Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and In-Person Patients [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Канада · 1 центр

• Mumford Professional Centre — Halifax

Публикации

• 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. PMID 38774367
• 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. PMID 34256184
• 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. PMID 39388061
• 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. PMID 37256878

Идентификаторы

NCT: NCT07322510 · REB File No. 1032019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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