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Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134429
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief 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.

Condition or disease Intervention/treatment
Pediatric Cancer Febrile Neutropenia Chemotherapy-induced Neutropenia Oncology Device: Everion

Detailed 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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Continuous Monitoring of Health Data With a Wearable Device in Pediatric Patients Undergoing Chemotherapy for Cancer - a Feasibility Pilot Study
Actual Study Start Date : November 29, 2019
Actual Primary Completion Date : January 13, 2020
Actual Study Completion Date : January 13, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Everion®
The Everion® will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.
Device: Everion
The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.




Primary Outcome Measures :
  1. Feasibility of continous monitoring of heart rate with the wearable device (WD) [ Time Frame: 14 days ]
    The primary outcome is defined as at least acceptable (≥50) quality score 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).


Secondary Outcome Measures :
  1. Continous monitoring of oxygen saturation with the WD [ Time Frame: 14 days ]
    At least acceptable (≥50) quality score 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).

  2. Continous monitoring of respiration rate with the WD [ Time Frame: 14 days ]
    At least acceptable(≥50) quality score 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).

  3. Continous monitoring of core temperature with the WD [ Time Frame: 14 days ]
    At least acceptable(≥50) quality score 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).

  4. Continous monitoring of heart rate variability with the WD [ Time Frame: 14 days ]
    At least acceptable (≥50) quality score 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).

  5. Continous monitoring of perfusion index with the WD [ Time Frame: 14 days ]
    At least acceptable quality score (0 to 5.2; no limit defined for acceptable quality) 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).

  6. Cumulative time of monitoring heart rate with the WD [ Time Frame: 14 days ]
    Cumulative length of time with monitored heart rate with at least acceptable quality score (≥50) per study day (continuous outcomes, measured daily).

  7. Cumulative time of monitoring oxygen saturation with the WD [ Time Frame: 14 days ]
    Cumulative length of time with monitored oxygen saturation with at least acceptable quality score (≥50) per study day (continuous outcomes, measured daily).

  8. Cumulative time of monitoring respiration rate with the WD [ Time Frame: 14 days ]
    Cumulative length of time with monitored respiration rate with at least acceptable quality score (≥50) per study day (continuous outcomes, measured daily).

  9. Cumulative time of monitoring core temperature with the WD [ Time Frame: 14 days ]
    Cumulative length of time with monitored core temperature with at least acceptable quality score (≥50) per study day (continuous outcomes, measured daily).

  10. Cumulative time of monitoring heart rate variability with the WD [ Time Frame: 14 days ]
    Cumulative length of time with monitored heart rate variability with at least acceptable quality score (≥50) per study day (continuous outcomes, measured daily).

  11. Cumulative time of monitoring perfusion index with the WD [ Time Frame: 14 days ]
    Cumulative length of time with monitored perfusion index with at least acceptable quality score (0 to 5.2; no limit defined for acceptable quality) per study day (continuous outcomes, measured daily).

  12. Device acceptance assessed with questionnaires [ Time Frame: 14 days ]
    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.

  13. Number and description of side effects [ Time Frame: 14 days ]
    Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.

  14. Effort for investigators assessed by number of contacts [ Time Frame: 14 days ]
    Effort (cumulative number of contacts) per study day for the Investigators.

  15. Effort for investigators assessed by duration of contacts [ Time Frame: 14 days ]
    Effort (cumulative duration of contacts) per study day for the Investigators.

  16. Comparison [ Time Frame: 14 days ]
    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.

  17. Exploration [ Time Frame: 14 days ]
    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, 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.



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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients under chemotherapy for any malignancy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134429


Locations
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Switzerland
Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Eva Brack, MD Pediatric Hematology/Oncology, Inselspital, Bern University Hospital
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04134429    
Other Study ID Numbers: Bern 2019 WD Pilot
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
wearable device
Everion®
Fever and Neutropenia
Pediatric Oncology
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases