Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

Oncology Clinical Trial

Official title:

Continuous Monitoring of Health Data With a Wearable Device in Pediatric Patients Undergoing Chemotherapy for Cancer - a Feasibility Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04134429
• Other study ID #: Bern 2019 WD Pilot
• Status: Completed
• Start date: November 29, 2019
• Est. completion date: January 13, 2020

Study information

• Verified date: May 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this pilot study the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer, is studied. Feasibility is assessed by the number of patients wearing the device on seven consecutive days for at least 18h/day, what will be measured by monitored heart rate. Study duration for each participant is 14 days.

Description:

No study has proved feasibility of continuous monitoring of health data with a small wearable device such as the device Everion® in pediatric patients. It is not known if children tolerate the device and if data quality sustains with smaller arm circumferences or when worn on the upper leg. Neither is it known if parents and/or patients can and are willing to handle the device in ambulant setting. Therefore, this pilot study assesses the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• 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 months at time of recruitment for myelosuppressive therapy or at least one cycle of myeloablative therapy.

• Age 1 month to <18 years at time of recruitment

• Written informed consent from patients and/or parents

Exclusion Criteria:

• Local skin diseases prohibiting wearing of the device.

• Denied written informed consent from patients and/or parent

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Febrile Neutropenia
• Neoplasms
• Neutropenia
• Oncology
• Pediatric Cancer

Intervention

Device:
• Everion
The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Koenig C, Ammann RA, Kuehni CE, Roessler J, Brack E. Continuous recording of vital signs with a wearable device in pediatric patients undergoing chemotherapy for cancer-an operational feasibility study. Support Care Cancer. 2021 Mar 3. doi: 10.1007/s00520 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)	The primary outcome is defined as at least acceptable (=50) quality score (worst quality 0, best quality 100) of heart rate during a cumulative duration of =18/24h per day (noon to noon), during =7 consecutive days within the 14 days of study duration (binary outcome, measured once).	14 days
Secondary	Continous Monitoring of Oxygen Saturation With the WD	At least acceptable (=50) quality score (worst quality 0, best quality 100) of oxygen saturation during a cumulative duration of =18/24h per day (noon to noon), during =7 consecutive days within the 14 days of study duration (binary outcome, measured once).	14 days
Secondary	Continous Monitoring of Respiration Rate With the WD	At least acceptable(=50) quality score (worst quality 0, best quality 100) of respiration rate during a cumulative duration of =18/24h per day (noon to noon), during =7 consecutive days within the 14 days of study duration (binary outcome, measured once).	14 days
Secondary	Continous Monitoring of Core Temperature With the WD	At least acceptable(=50) quality score (worst quality 0, best quality 100) of core temperature during a cumulative duration of =18/24h per day (noon to noon), during =7 consecutive days within the 14 days of study duration (binary outcome, measured once).	14 days
Secondary	Continous Monitoring of Heart Rate Variability With the WD	At least acceptable (=50) quality score (worst quality 0, best quality 100) of heart rate variability during a cumulative duration of =18/24h per day (noon to noon), during =7 consecutive days within the 14 days of study duration (binary outcome, measured once).	14 days
Secondary	Continous Monitoring of Perfusion Index With the WD	At least acceptable (=50) quality score (worst quality 0, best quality 100) of perfusion index during a cumulative duration of =18/24h per day (noon to noon), during =7 consecutive days within the 14 days of study duration (binary outcome, measured once).	14 days
Secondary	Cumulative Time of Monitoring Heart Rate With the WD	Cumulative length of time with monitored heart rate with at least acceptable quality score (=50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).	14 days
Secondary	Cumulative Time of Monitoring Oxygen Saturation With the WD	Cumulative length of time with monitored oxygen saturation with at least acceptable quality score (=50 worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).	14 days
Secondary	Cumulative Time of Monitoring Respiration Rate With the WD	Cumulative length of time with monitored respiration rate with at least acceptable quality score (=50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).	14 days
Secondary	Cumulative Time of Monitoring Core Temperature With the WD	Cumulative length of time with monitored core temperature with at least acceptable quality score (=50, worst quality 0, best quality 100)) per study day (continuous outcomes, measured daily).	14 days
Secondary	Cumulative Time of Monitoring Heart Rate Variability With the WD	Cumulative length of time with monitored heart rate variability with at least acceptable quality score (=50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).	14 days
Secondary	Cumulative Time of Monitoring Perfusion Index With the WD	Cumulative length of time with monitored perfusion index with at least acceptable quality score (=50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).	14 days
Secondary	Device Acceptance Assessed With Questionnaires	Proportion of patients and parents indicating that continuous monitoring with the wearable device (WD) is acceptable per day and per entire study duration and reasons not to wear the device.	14 days
Secondary	Number and Description of Side Effects	Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.	14 days
Secondary	Effort for Investigators Assessed by Number of Contacts	Effort (cumulative number of contacts) for the Investigators.	14 days
Secondary	Effort for Investigators Assessed by Duration of Contacts	Effort (cumulative duration of contacts) for the Investigators.	14 days
Secondary	Comparison	Difference between discrete measurements performed for clinical routine cares of heart rate and the mean of continuously measured heart rate within +/-10min at times of the discrete measurement.	14 days
Secondary	Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection	Exploration of potential changes in or specific patterns of all collected signals and their quality scores in combination (heart rate, oxygen saturation, respiration rate, core temperature, skin temperature, heart rate variability, perfusion index, health score (0-100, higher score means better health), galvanic skin response) , within 48 hours before and after clinical diagnosis of fever (ear temperature of =39.0°C, or =38.5°C if fever is declared for clinical reasons) with or without neutropenia and microbiologically or clinically defined infections, if applicable.	14 days