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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Patient Program Adherence
Study Overview
Brief Summary
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:
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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.
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Compare clinical outcomes between users and non-users of the device within the HEARTS in Sync program, by:
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Tracking patient enrollment, attendance in virtual education sessions, and program completion rates,
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Evaluating change in patient bloodwork outcomes,
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Measuring change is physical ability,
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Analyzing changes in eating behaviours, and
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Examining quality of life using validated tools.
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Asses the feasibility of the CardioWatch 287-2 for the HEARTS in Sync virtual CR program by:
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Assessing device adherence
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Reviewing patient feedback survey, and
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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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who meet CR inclusion criteria requirements and who are enrolling in virtual cardiac rehab program, HEARTS in Sync, in Nova Scotia.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Patient Program Adherence
Time Frame: From enrollment to 13-week program completion
The proportion (%) of program sessions attended by each patient, comparing device users and non-device user. Attendance percentage will be obtained by program records.
Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and Non-Device Users
Time Frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Metabolic Equivalents measured during the baseline exercise stress test and discharge stress test.
Change in Fat Intake Score Between Device Users and Non-Device Users
Time Frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in patient fat intake score measured using a validated nutrition questionnaire at baseline and discharge.
Change in Fibre Intake Score Between Device Users and Non-Device Users
Time Frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in patient fibre intake score measured using a validated nutrition questionnaire at baseline and discharge.
Change in Sodium Intake Score Between Device Users and Non-Device Users
Time Frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in patient sodium intake score measured using a validated nutrition questionnaire at baseline and discharge.
Change in Sugar Intake Score Between Device Users and Non-Device Users
Time Frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in patient fat intake score measured using a validated nutrition questionnaire at baseline and discharge.
Change in Quality of Life Ladder Score Between Device Users and Non-Device Users
Time Frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Examine change in patient-reported quality of life using the Quality of Life Ladder at initial/baseline and discharge report.
Change in Satisfaction with Life Between Device Users and Non-Device Users
Time Frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Examine change in patient-reported quality of life using the Satisfaction with Life Scale at initial/baseline and discharge report.
Characterize Participants
Time Frame: Initial (at assessment)
Determine demographic and health history between device users and non-device users
Device Adherence to Wearing the CardioWatch 287-2
Time Frame: From enrollment to the end of the program at 13-weeks
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.
Patient-Reported Usability and Acceptability of the CardioWatch 287-2
Time Frame: After completion of the program (e.g. after 13 weeks)
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.
Clinician-Reported Usability of the CardioWatch 287-2 System
Time Frame: Up to 1 year after study completion
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.
Change in Triglyceride Level Change Between Device Users and Non-Device Users
Time Frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Triglycerides (mmol/L) will be measured via standard blood panel.
Change in Total Cholesterol Level Change Between Device Users and Non-Device Users
Time Frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Total cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Change in HDL Cholesterol Level Change Between Device Users and Non-Device Users
Time Frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
HDL cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Change in LDL Cholesterol Level Change Between Device Users and Non-Device Users
Time Frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
LDL cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Change in Hemoglobin A1C Level Change Between Device Users and Non-Device Users
Time Frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
HbA1C (%) will be measured via standard bloodwork.
Change in Systolic Blood Pressure Between Device Users and Non-Device Users
Time Frame: Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)
Systolic blood pressure (mmHg) measured by a blood pressure monitor.
Change in Diastolic Blood Pressure Between Device Users and Non-Device Users
Time Frame: Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)
Diastolic blood pressure (mmHg) measured by a blood pressure monitor.
Change in Resting Heart Rate between Device Users and Non-Device Users
Time Frame: Initial (at assessment) and Discharge (near end of program completion, up to 6 weeks after program completion)
Resting heart rate (beats per minute) will be measured at assessment and near end of program completion
Secondary Outcomes
- Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and In-Person Patients(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(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(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(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(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(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(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(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(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(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(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(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(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(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(Initial (at assessment) and Discharge (near end of program completion, up to 6 weeks after program completion))
Investigators
Nicholas Giacomantonio
Medical Director - REDUCE-IT, Cardiologist
Nova Scotia Health Authority