| Literature DB >> 36107471 |
Kaio Jia Bin1, Lucas Ramos De Pretto1, Fabio Beltrame Sanchez1, Linamara Rizzo Battistella1.
Abstract
BACKGROUND: Monitoring vital signs such as oximetry, blood pressure, and heart rate is important to follow the evolution of patients. Smartwatches are a revolution in medicine allowing the collection of such data in a continuous and organic way. However, it is still a challenge to make this information available to health care professionals to make decisions during clinical follow-up.Entities:
Keywords: clinical intervention; clinical trial; digital health; digital platform; mobile health; sensitive data; smartwatch; telemedicine; telemonitoring; wearable
Year: 2022 PMID: 36107471 PMCID: PMC9523529 DOI: 10.2196/40468
Source DB: PubMed Journal: JMIR Form Res ISSN: 2561-326X
Information collected from the smartwatch for this study.
| Data | Collection | Present at digital solution |
| Steps | Automatically | No |
| Flights of stairs | Automatically | No |
| Exercise time | Automatically | No |
| Sleep quality | Automatically | Yes |
| Heart rate | Automatically | Yes |
| Oxygen saturation during sleep | Automatically | No |
| Oxygen saturation | User action | Yes |
| Blood pressure | User action | Yes |
| Weight | User action | No |
| Height | User action | No |
| Quantity and type of liquid ingested | User action | No |
| Quantity and type of food ingested | User action | No |
Figure 1Data flow from smartwatches. HCFMUSP: Hospital das Clinicas da Faculdade de Medicina of University of São Paulo.
Figure 2Data flow from Research Electronic Data Capture (REDCap).
Figure 3Comparison of the flow of data collected by the digital platform with those recorded in Research Electronic Data Capture (REDCap), on the paper form, and by smartwatch.
Total of users by weeks of the project.
| Week number | New users, n | Number of users who dropped out, n | Total users, n |
| 1 | 2 | 0 | 2 |
| 2 | 7 | 0 | 9 |
| 3 | 8 | 0 | 17 |
| 4 | 5 | 0 | 22 |
| 5 | 9 | 0 | 31 |
| 6 | 6 | 0 | 37 |
| 7 | 4 | 1 | 40 |
| 8 | 9 | 1 | 48 |
| 9 | 2 | 1 | 49 |
| 10 | 7 | 0 | 56 |
| 11 | 3 | 0 | 59 |
| 12 | 2 | 0 | 61 |
| 13 | 6 | 0 | 67 |
| 14 | 1 | 0 | 68 |
Total data records by type and per user (N=2,772,766).
| Data type | Records, n | Total users, n | Users with no synchronization, n |
| Continuous heart rate (bpm) | 2,645,286 | 68 | 9 |
| Oxygen saturation | 7423 | 68 | 1 |
| Blood pressure | 4742 | 68 | 10 |
| Sleep | 3599 | 68 | 0 |
| Sleep intensity | 111,716 | 68 | 0 |
Descriptive statistics of all the collected vital signs.
| Data type | Results | |||||
|
| Mean (SD) | 95% CI | 25th percentile | 50th percentile | 75th percentile | |
| Heart rate (bpm) | 78.29 (13.63) | 78.27-78.30 | 69.00 | 77.00 | 86.00 | |
| Oxygen saturation (%) | 94.37 (3.47) | 94.29-94.45 | 93.00 | 95.00 | 97.00 | |
|
| ||||||
|
| Systolic | 126.78 (15.06) | 126.35-127.21 | 116.00 | 127.00 | 136.00 |
|
| Diastolic | 82.45 (12.16) | 82.10-82.79 | 73.00 | 83.00 | 92.00 |
Time spent in each sleep stage across all recorded minutes (1,046,195 minutes).
| Sleep phase | Overall recorded minutes (% of total) |
| Awake | 122,898 (11.75) |
| Light sleep | 590,433 (56.43) |
| Deep sleep | 119,148 (11.39) |
| REMa sleep | 213,716 (20.43) |
aREM: rapid eye movement.
Type and number of alerts and number of volunteers who triggered each alert.
| Type of alert | Number of alerts (n=421) | Number of volunteers (n=45) |
| Maximum diastolic blood pressure (≥180 mm Hg) | 1 | 1 |
| Minimum diastolic blood pressure (≤70 mm Hg) | 0 | 0 |
| Maximum systolic blood pressure (≥120 mm Hg) | 3 | 1 |
| Minimum systolic blood pressure (≤40 mm Hg) | 0 | 0 |
| Low oxygen saturation (<88%) | 414 | 43 |
| Low heart rate (<40 bpm) | 3 | 2 |
Number of volunteers with synchronization (sync) errors.
| Volunteers | Sync OK (n=59), n | Sync error (n=9), n | cBPMa records (n=2,645,286), n |
| Wth own smartphone | 30 | 4 | 1,349,706 |
| With study´s smartphone | 29 | 5 | 1,295,580 |
acBPM: continuous beats per minute.
Synchronization time according to the smartphone used.
| Sync time | Study’s smartphone (n=1,295,580) | Volunteer’s smartphone (n=1,349,706) | |||
|
| Number synced, n (%) | Accumulated % | Number synced, n (%) | Accumulated % | |
| <1 hour | 5051 (0.39) | 0.39 | 4400 (0.33) | 0.33 | |
| 1-2 hours | 59,892 (4.62) | 5.01 | 51,555 (3.82) | 4.15 | |
| 3-6 hours | 193,524 (14.94) | 19.95 | 166,518 (12.34) | 16.48 | |
| 6-12 hours | 278,549 (21.50) | 41.45 | 266,397 (19.74) | 36.22 | |
| 13-24 hours | 349,405 (26.97) | 68.42 | 452,547 (33.53) | 69.75 | |
| 1-2 days | 143,495 (11.08) | 79.49 | 196,683 (14.57) | 84.32 | |
| 3-7 days | 154,646 (11.94) | 91.43 | 131,064 (9.71) | 94.03 | |
| 7-14 days | 78,115 (6.03) | 97.46 | 55,495 (4.11) | 98.14 | |
| >14 days | 32,903 (2.54) | 100 | 25,047 (1.86) | 100 | |
Total investment on devices and equipment.
| Device | Quantity, n | Investment (US $) |
| Samsung Galaxy 4 smartwatch | 84 | 19,828.73 |
| Noninvasive blood pressure monitor | 92 | 1866.57 |
| Pulse oximeter for noncontinuous monitoring | 92 | 1130.24 |
| Samsung Galaxy A52 smartphone | 45 | 16,228.44 |