Clinical Trial Radar

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: 1. High compliance: ≥ 50% daily wear time (\~12 hours/day on all 7 days/week) 2. Moderate compliance: ≥ 25% daily wear time (\~6 hours/day) 3. 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)

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)