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Patients admitted to the General Internal Medicine ward are sick and in need of monitoring that cannot be provided at home or treatments best administered in hospital. Standard care currently includes vital signs measurements and in some cases ECG. Wearable devices that continuous monitor patients could provided added information to improve the care of inpatients. This could include more monitoring and catching deterioration before it happens. Wearables have been shown to be largely accurate for monitoring heart rate, however it is still necessary to determine if they can reliably measure sleep, activity, and other health metrics. For this, study investigators are evaluating the validity of FitBit Sense 2 (or other FitBit devices) for measurement of sleep, activity, heart rate, respiratory rate, and oxygen saturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General internal medicine patients admitted to General Medicine Wards | Intervention: Fitbit Sense 2 (Fitbit, San Francisco, CA, USA) Gold standard devices: To compare measures, patients will be asked to wear the following for 24 hours:
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| Measure | Description | Time Frame |
|---|---|---|
| Fitbit Sense 2 vs. StepWatch for activity (step count) | Comparisons of step counts between Fitbit and Modus StepWatch | Collected over 24 hours in 1 min bins |
| Fitbit Sense 2 vs. Nox T3 for heart rate (bpm) | Comparisons of HR between Fitbit and Nox pulse oximeter | Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins |
| Fitbit Sense 2 vs. Nox T3 for respiratory rate (breaths per minute) | Comparisons of RR between Fitbit and Nox RIP (respiratory inductive plethysmograph) | Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins. |
| Fitbit Sense 2 vs. Nox T3 for oxygen saturation (SpO2, %) | Comparisons of SpO2 between Fitbit and Nox T3 | Fitbit collected over 24 hours in 1 min bins and Nox collected during nighttime sleep in 1 sec bins. |
| Fitbit Sense 2 vs. Nox T3 for total sleep time (min) | Comparisons of sleep TST between Fitbit and Nox T3 | Fitbit and Nox T3 collected during nighttime sleep (1 night) |
| Fitbit Sense 2 vs. Nox T3 for sleep efficiency (%) | Comparisons of SE between Fitbit and Nox T3 | Fitbit and Nox T3 collected during nighttime sleep (1 night) |
| Fitbit Sense 2 vs. Nox T3 for sleep stages (%, min) |
| Measure | Description | Time Frame |
|---|---|---|
| Fitbit Sense 2 vs. Sleep Diary for total sleep time (min) | Comparisons of total sleep time between Fitbit and self-reported sleep diary. | Collected during nighttime sleep (1 night) |
| Fitbit Sense 2 vs. Sleep Diary for sleep efficiency (%) |
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Subject inclusion criteria.
Subject exclusion criteria.
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The population will be General Internal Medicine inpatients on the GIM wards. Patients who can provide informed consent will be approached for enrollment. Exclusion criteria are patients who are purely palliative and therefore in which vital sign measurement would be inappropriate.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G2C4 | Canada |
This study requested sharing of IPD in the ethics application.
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Comparisons of sleep stages (NREM - stage 1-3, REM) between Fitbit and Nox T3
| Fitbit and Nox T3 collected during nighttime sleep (1 night) |
| Fitbit Sense 2 vs. Nox T3 for wake after sleep onset (min) | Comparisons of WASO between Fitbit and Nox T3 | Fitbit and Nox T3 collected during nighttime sleep (1 night) |
| Fitbit Sense 2 vs. Nox T3 for time of sleep onset and wake time | Comparisons of sleep onset time and wake time between Fitbit and Nox T3 | Fitbit and Nox T3 collected during nighttime sleep (1 night) |
Comparisons of sleep efficiency between Fitbit and self-reported sleep diary.
| Collected during nighttime sleep (1 night) |
| Fitbit Sense 2 vs. Sleep Diary for time of sleep schedule | Comparisons of time of sleep between Fitbit and self-reported sleep diary. | Collected during nighttime sleep (1 night) |
| Fitbit Sense 2 vs. Sleep Diary for wake after sleep onset (min) | Comparisons of WASO between Fitbit and self-reported sleep diary. | Collected during nighttime sleep (1 night) |
| Subgroup analysis based on gender | Gender-based subgroup analysis of outcomes | Collected at study baseline |
| Subgroup analysis based on comorbidities | Descriptive data on participant comorbidities (e.g., presence of mobility limiting conditions, etc; yes/no) or subgroup analysis by comorbidities | Collected at study baseline |
| Subgroup analysis based on use of walking aids | Subgroup analysis by walking aid usage or descriptive data on walking aid use among participants (e.g., yes vs. no) | Collected at study baseline |