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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04914702
Other study ID # Bern/Basel 2021 WD Pilot
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 16, 2021
Est. completion date March 1, 2022

Study information

Verified date July 2022
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this pilot study the feasibility continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied. Vital signs and are recorded with two different wearable devices (WDs): Everion®, by Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland. Patients can choose if they want to wear one or both WDs during this study. Those opting to wear two WDs can choose if they want to wear them in parallel, or sequentially. Results from the two different WDs will be compared. Study duration for each participant is 14 days per device.


Description:

In a previous study (Bern 2019 WD Pilot, NcT04134429) the investigators found that continuous recording of vital signs with the Everion® is feasible in good quality across a wide age range (3 to 16 years) of pediatric patients undergoing chemotherapy for cancer. However, the pre-defined criterion to claim feasibility was not formally reached and low compliance was the main reason identified. In this study the investigators want to assess the impact of measures aiming to increase compliance on feasibility for the Everion®. Second, the investigators want to assess the feasibility of a second device, made commercially available only in October 2020, the CORE® WD by GreenTEG. Results from the two different wearable devices will be compared. Study duration for each participant is 14 days per device.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Month to 17 Years
Eligibility Inclusion Criteria: - Chemotherapy treatment because of any malignancy, expected to last =1 month at time of recruitment for myelosuppressive therapy; or at least one cycle of myeloablative therapy requiring autologous (Bern/Basel) or allogeneic (Basel) hematopoietic stem cell transplantation. - Age from 1 month to 17.99 years at time of recruitment - Written informed consent from parents and participants, where applicable Exclusion Criteria: - Local skin diseases prohibiting wearing of the WD. - Denied written informed consent from participants

Study Design


Intervention

Device:
Everion®
The Everion® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.
CORE®
The CORE® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.

Locations

Country Name City State
Switzerland University Children's Hospital Basel, University of Basel Basel
Switzerland Inselspital Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

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
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