Home-monitoring of physical activity and vital parameters of pediatric patients following admission due to pneumonia, bronchiolitis or asthma.

The past years, the use of smartwatches in medical science has increased.
Recent systematic reviews have reported studies that used a smartwatch to
measure activity level, eating behavior and seizures, among other things.
However, these studies are almost always performed on adults and usually in a
lab setting. This way of collecting data thus seems to warrant further
validation among children. In the future, CHDR aims to perform clinical trials
in pediatric patients using home-monitoring techniques. Clinical research in
children is difficult to perform due to the invasive and time-consuming nature
of current study protocols. One option to overcome these problems is frequent,
non-invasive monitoring of symptoms and disease activity in a home-setting.

CHDR has developed a home-monitoring platform that comprises several devices,
one of which is the Nokia Steel HR. This wearable device can monitor physical
activity levels, measure pulse rate and analyze sleep pattern and sleep
duration. Furthermore, the platform consists of a Nokia thermometer, Nokia
scales that can measure weight and body composition and an in-house developed
smartphone app that collects and transmits the data, adds a questionnaire
function and which can utilize other android phone functions. Several other
devices will be added to the platform in the future. In the last year, a pilot
study has been performed in the Children*s hospital in Basel, during which the
CHDR home-monitoring platform has been improved.

Further home-monitoring research, aimed at quantifying disease-activity, will
be performed at the Juliana Children*s Hospital in the Hague. Community
acquired pneumonia, bronchiolitis, preschool wheezing and asthma are common
diagnoses that are characterized by respiratory complaints and often warrant
admission. When patients are stabilized and do not need oxygen therapy,
discharge follows swiftly. However, there is very little evidence available on
the impact on daily life after discharge and the time till full recovery. In
the past, studies have relied on parent-reported recovery via phone interview,
but objective data is generally not available. This study aims to investigate
this, while also validating the CHDR home-monitoring platform further to make
it suitable for future clinical trials.

- To determine a mean recovery period for patients admitted with pneumonia,
bronchiolitis, preschool wheezing and asthma by using data obtained during
admission and via home-monitoring of a two week period following admission and
control period and 40 days after admission.
- To investigate physical activity levels during and after a hospital admission
due to community acquired pneumonia, bronchiolitis or asthma in a pediatric
population
- To compare the calculated mean recovery time to parent reported recovery time.
- To identify baseline or treatment factors that correlate with a longer
recovery time (e.g. oxygen therapy, abnormal x-ray, treatment with steroids for
pre-school wheezing and asthma)
- To determine correlations between low activity levels and symptom scores,
heart rate and other collected data.
- To determine the feasibility, quality and quantity (wear time) of data
collection in different age groups.
- To evaluate the ePro questionnaire and notifications app.

Observational case-control study to determine recovery time after a hospital
admission due to community acquired pneumonia, bronchiolitis or asthma and to
validate the CHDR home monitoring program in Juliana Children*s Hospital.

The burden for study participants is estimated to be low and consists of the
continuous wearing of the Nokia Steel HR watch and a once to twice (asthma
subjects) daily questionnaire and daily temperature measurement (children with
preschool wheezing and lower respiratory tract infection) for the duration of
the study period. Furthermore, for patients with asthma, an additional daily
spirometry assessment is part of the study. No invasive procedures are included
in this study. There are no significant health risks associated with the study
assessments. Furthermore, we do not expect any risks regarding the
psychological or social state of study participants. With the exception of the
smartwatch assessments, for which data will be collected continuously, all
study mandated actions can be performed at the subjects* home or hospital room.
Collected digital data will pass through adequately protected data servers,
which will prevent privacy infractions. Furthermore, the study assessments will
not be used to influence the clinical decision process.

The proposed study can only be performed in this group of paediatric patients
as described above. Performing this study in an adult population would yield
major difficulties since behaviour and recovery in adult patients is
significantly different when compared to children.