HEARTS in Sync + CardioWatch 287-2
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who meet CR inclusion criteria requirements and who are enrolling in virtual cardiac rehab program, HEARTS in Sync, in Nova Scotia.
Disqualifiers
Huawei P8 Lite
Huawei P9 Lite
Xiaomi Mi 6
Huawei P20 Lite
Trial design
Design model
Single group
Treatments tested in this trial
Remote Patient Monitoring with Corsano CardioWatch 287-2
DeviceParticipants 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.
Treatment groups
216 Participants
are divided into 1 treatment groupGroup A: Virtual Cardiac Rehab + Corsano CardioWatch 287-2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to 13-week program completion2
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.
Time frame
Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)3
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.
Time frame
Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)4
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.
Time frame
Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)Secondary outcomes
1
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.
Time frame
Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)2
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.
Time frame
Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)3
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.
Time frame
Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)4
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.
Time frame
Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nova Scotia Health Authority
Lead sponsor
Corsano Health B.V.
Collaborator
Source ClinicalTrials.gov
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