Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Feasibility of continous recording of core temperature with the two wearable devices (WDs) |
The primary outcome is defined as at least sufficient data quality (Everion® =50, quality score 0 (lowest) to 100 (best); CORE® =2, quality score 1 (lowest) to 4 (best)) of core temperature measurement, with arrival on dashboard =30 minutes after recording, during a cumulative duration of =18/24h per day (midnight to midnight), on =7 days within the 14 days of the study period. |
14 days |
|
Secondary |
Feasibility of continous recording of heart rate with the Everion® |
At least sufficient data quality (Everion® =50, quality score 0 (lowest) to 100 (best) of heart rate measurement, with arrival on dashboard =30 minutes after recording, during a cumulative duration of =18/24h per day (midnight to midnight), on =7 days within the 14 days of the study period. |
14 days |
|
Secondary |
Feasibility of continous recording of heart rate variability with the Everion® |
At least sufficient data quality (Everion® =50, quality score 0 (lowest) to 100 (best) of heart rate variability measurement, with arrival on dashboard =30 minutes after recording, during a cumulative duration of =18/24h per day (midnight to midnight), on =7 days within the 14 days of the study period. |
14 days |
|
Secondary |
Feasibility of continous recording of respiration rate with the Everion® |
At least sufficient data quality (Everion® =50, quality score 0 (lowest) to 100 (best) of respiration rate measurement, with arrival on dashboard =30 minutes after recording, during a cumulative duration of =18/24h per day (midnight to midnight), on =7 days within the 14 days of the study period. |
14 days |
|
Secondary |
Cumulative time of monitoring core temperature with the two wearable devices (WDs) |
Cumulative length of time with recorded core temperature with at least sufficient data quality (Everion® =50, quality score 0 (lowest) to 100 (best); CORE® =2, quality score 1 (lowest) to 4 (best)) per study day. |
14 days |
|
Secondary |
Cumulative time of monitoring heart rate with the Everion® |
Cumulative length of time with recorded heart rate with at least sufficient data quality (Everion® =50, quality score 0 (lowest) to 100 (best)) per study day. |
14 days |
|
Secondary |
Cumulative time of monitoring heart rate variability with the Everion® |
Cumulative length of time with recorded heart rate variability with at least sufficient data quality (Everion® =50, quality score 0 (lowest) to 100 (best)) per study day. |
14 days |
|
Secondary |
Cumulative time of monitoring respiration rate with the Everion® |
Cumulative length of time with recorded respiration rate with at least sufficient data quality (Everion® =50, quality score 0 (lowest) to 100 (best)) per study day. |
14 days |
|
Secondary |
Data arrival on the dashboard for core temperature (Everion®) |
Cumulative length of time with data arrival on the dashboard =30 minutes after recording (continuous outcome, measured daily) for core temperature for the Everion® |
14 days |
|
Secondary |
Data arrival on the dashboard for core temperature (CORE®) |
Cumulative length of time with data arrival on the dashboard =30 minutes after recording (continuous outcome, measured daily) for core temperature for the CORE® |
14 days |
|
Secondary |
Effort for investigators assessed by number of contacts |
Cumulative number of contacts with the participants for the Investigators. |
14 days |
|
Secondary |
Effort for investigators assessed by duration of contacts |
Cumulative duration of contacts with the participants for the Investigators. |
14 days |
|
Secondary |
Acceptability of Everion® |
Proportion of participants indicating that continuous monitoring with the Everion® is acceptable (binary outcome, measured once). |
14 days |
|
Secondary |
Acceptability of CORE® |
Proportion of participants indicating that continuous monitoring with the CORE® is acceptable (binary outcome, measured once). |
14 days |
|
Secondary |
Side Effects |
Number and description of side effects reported by participants, if applicable (categorical outcome) and comparison of the side-effects of the two different WDs. |
14 days |
|
Secondary |
User-friendliness |
Comparison of the user-friendliness and preference of the different WDs as judged by the participants (categorical outcome, assessed with questionnaires) |
14 days |
|
Secondary |
Comparison of core temperature with discrete measurements |
Difference between discrete measurements of core temperature, performed by the participants, if applicable, twice daily or more if clinically indicated and the measured signal from both WDs at the corresponding time. |
14 days |
|
Secondary |
Exploration |
Exploration of potential changes in or specific patterns of all measured signals within 48 hours before clinical diagnosis of fever, with or without neutropenia, if applicable. |
14 days |
|