Trial Outcomes & Findings for Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy (NCT NCT04134429)

NCT ID: NCT04134429

Last Updated: 2021-07-08

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2021-07-08

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Everion® n=20 Participants 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.
Age, Continuous	6 years n=20 Participants
Sex: Female, Male Female	9 Participants n=20 Participants
Sex: Female, Male Male	11 Participants n=20 Participants
Region of Enrollment Switzerland	20 participants n=20 Participants
Type of malignancy Acute lymphoblastic leukemia	12 Participants n=20 Participants
Type of malignancy Other hematologic malignancies	2 Participants n=20 Participants
Type of malignancy Central nervous system tumor	3 Participants n=20 Participants
Type of malignancy Solid tumor	3 Participants n=20 Participants

PRIMARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=20 Participants 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.
Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)	6 Participants

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=20 Participants 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.
Continous Monitoring of Oxygen Saturation With the WD	0 Participants

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=20 Participants 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.
Continous Monitoring of Respiration Rate With the WD	4 Participants

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=20 Participants 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.
Continous Monitoring of Core Temperature With the WD	6 Participants

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=20 Participants 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.
Continous Monitoring of Heart Rate Variability With the WD	1 Participants

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=20 Participants 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.
Continous Monitoring of Perfusion Index With the WD	6 Participants

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=6576 hours 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.
Cumulative Time of Monitoring Heart Rate With the WD	3992 hours

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=6576 hours 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.
Cumulative Time of Monitoring Oxygen Saturation With the WD	1103 hours

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=6576 hours 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.
Cumulative Time of Monitoring Respiration Rate With the WD	4058 hours

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=6576 hours 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.
Cumulative Time of Monitoring Core Temperature With the WD	4037 hours

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=6576 hours 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.
Cumulative Time of Monitoring Heart Rate Variability With the WD	3142 hours

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Measure	Everion® n=6576 hours 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.
Cumulative Time of Monitoring Perfusion Index With the WD	3992 hours

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Everion® n=20 Participants 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.
Device Acceptance Assessed With Questionnaires	18 Participants

SECONDARY outcome

Timeframe: 14 days

Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.

Outcome measures

Measure	Everion® n=20 Participants 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.
Number and Description of Side Effects irritated skin	4 Participants
Number and Description of Side Effects Superficial skin lesion	1 Participants
Number and Description of Side Effects itching	3 Participants
Number and Description of Side Effects sweating	7 Participants

SECONDARY outcome

Timeframe: 14 days

Effort (cumulative number of contacts) for the Investigators.

Outcome measures

Measure	Everion® n=20 Participants 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.
Effort for Investigators Assessed by Number of Contacts	52 Total number of contacts

SECONDARY outcome

Timeframe: 14 days

Effort (cumulative duration of contacts) for the Investigators.

Outcome measures

Measure	Everion® n=20 Participants 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.
Effort for Investigators Assessed by Duration of Contacts	390 minutes

SECONDARY outcome

Timeframe: 14 days

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Population: The 4 episodes occured in 3 of these 20 patients. The other 17 patients had no episode 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.

Outcome measures

Measure	Everion® n=20 Participants 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.
Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection Episodes with fever	3 Episodes
Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection Episodes with Infection	1 Episodes

Adverse Events

Everion®

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Everion® n=20 participants at risk 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.
Skin and subcutaneous tissue disorders Superficial skin lesion	5.0% 1/20 • Number of events 20 • 17 days

Additional Information

Dr. med. Christa König

insel Gruppe AG

Phone: +41 31 632 21 11

Email: christa.koenig@insel.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place