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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everion | Device | The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients under chemotherapy for any malignancy
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| Name | Affiliation | Role |
|---|---|---|
| Eva Brack, MD-PhD | Pediatric Hematology/Oncology, Inselspital, Bern University Hospital | Principal Investigator |
| Christa Koenig, MD | Pediatric Hematology/Oncology, Inselspital, Bern University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33655413 | Result | 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 Sep;29(9):5283-5292. doi: 10.1007/s00520-021-06099-8. Epub 2021 Mar 3. |
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The coded study data (from the WD and clinical data) will be uploaded to figshare and made publically available for other researchers.
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After publication of the study results.
Open access
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | 14 days |
|
17 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
(i) The WDs were studied for only 14 days and compliance might be different during long-term use.
(ii) The small number of patients precluded an analysis of patient factors (iii) The planned comparison of discrete measurements versus continuously was not feasible because the exact second-wise time point of discrete measurements was not available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. med. Christa König | insel Gruppe AG | +41 31 632 21 11 | christa.koenig@insel.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2019 | Apr 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D064147 | Febrile Neutropenia |
| D005334 | Fever |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Number and Description of Side Effects | Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires. | 14 days |
| Effort for Investigators Assessed by Number of Contacts | Effort (cumulative number of contacts) for the Investigators. | 14 days |
| Effort for Investigators Assessed by Duration of Contacts | Effort (cumulative duration of contacts) for the Investigators. | 14 days |
| 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 |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of malignancy | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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). | Posted | Count of Participants | Participants | 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). | Posted | Count of Participants | Participants | 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). | Posted | Count of Participants | Participants | 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). | Posted | Count of Participants | Participants | 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). | Posted | Count of Participants | Participants | 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). | Posted | Count of Units | hours | 14 days | hours | hours |
|
|
|
| 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). | Posted | Count of Units | hours | 14 days | hours | hours |
|
|
|
| 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). | Posted | Count of Units | hours | 14 days | hours | hours |
|
|
|
| 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). | Posted | Count of Units | hours | 14 days | hours | hours |
|
|
|
| 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). | Posted | Count of Units | hours | 14 days | hours | hours |
|
|
|
| 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). | Posted | Count of Units | hours | 14 days | hours | hours |
|
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 14 days |
|
|
|
| Secondary | Effort for Investigators Assessed by Number of Contacts | Effort (cumulative number of contacts) for the Investigators. | Posted | Number | Total number of contacts | 14 days |
|
|
|
| Secondary | Effort for Investigators Assessed by Duration of Contacts | Effort (cumulative duration of contacts) for the Investigators. | Posted | Number | minutes | 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. | The analysis of differences between discrete measurements and continuously recorded aggregates of vital signs, as defined in the protocol, was found to yield massively distorted results because rapidly changing discretely measured vital signs were compared to aggregated means covering up to 20 min. We deliberately refrain from displaying these nonmeaningful results here. | Posted | 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. | The 4 episodes occured in 3 of these 20 patients. The other 17 patients had no episode with fever or infection. | Posted | Number | Episodes | 14 days |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| sweating |
|