Protocol for gathering data for the pediatric control groups of various CHDR trial@home studies with wearable technology and smart-phone applications.

Chronic diseases impairs the daily life and routine of a child and adolescent.
These children are treated over a long time. The child is prone to visit the
hospital or any other treatment center more frequently than his/her peers. This
could be just for simple tests to assess the vitality of the child but with
disproportional impact. With the current technology a lot of these vital
parameters (e.g. physical activity, weight, blood pressure, temperature, pain
and general well-being) could be assessed at home using wearables and smart
phone applications.

The use of wearable devices (e.g. Fitbit, Garmin and Nokia) is increasing in
clinical research. The normal daily life behavior of a child is currently
unknown to a medical specialist. The specialist relies on clinical tests and
subjective recall to assess if certain treatments have worked. In combination
with accompanying questionnaire applications these wearables are able to
monitor the behavior of its wearer in an at home setting[!]. This feature could
be of benefit to monitor patients with a chronic disease over a longer period
of time without it being invasive to the patient. Especially children could
benefit from at home monitoring with wearables, since a doctor could monitor
himself if a behavior is normal and if a child is required to go the hospital
for a check-up.

This study is part of the first phase of the trial@home project. If the
wearables are assessed as valid and feasible enough to be used in paediatrics,
then different interventions could be researched and the real life conditions
of a child could be monitored. Therefore the goal of this study is to
demonstrate the feasibility of using wearable technology in an at home setting
for healthy/undiagnosed children. In addition the study is designed in such a
way that the results of this study can be used as control groups in other
studies of the trial@home project, such as CHDR1810 and CHDR1811 where
wearables are used to monitor paediatric patients to minimize the burden and
number of subjects.

- To determine the tolerability, feasibility and quality of the employed
methods of data collection in different age groups.
- To investigate inter-subject variability and normal-values regarding step
count, heart rate, sleep duration, blood pressure, body composition and smart
phone use of healthy children in an at home situation.
- To evaluate adherence to study tasks in paediatric subjects.
- To evaluate correlations between collected data and questionnaire output.
- To compare collected data of healthy subjects with paediatric patient
subjects of related projects CHDR1810 and CHDR1811.

Observational prospective non-invasive study of data gathering in an at-home
situation. The children will be followed for a period of 21 days. There are
three groups of children. The groups and their respective device combination
are comparable with the subject groups of CHDR studies 1810 and 1811.

There is no direct health benefit for the participants, there is only a small
compensation with a gift certificate. There is also minimal risk for the
participants, since all the devices that are used by the children, have a CE
brand and therefore eligible for consumer use. All the data is pseudonymized
according to the GDPR laws and therefore the privacy of the participants and
their parents is maintained