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ID
Source
Brief title
Health condition
Healthy subjects, children
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Daily step count
Secondary outcome
- Baseline information: including age, weight, length, school and city
- Daily heart rate data
- Biweekly temperature
- Daily sleep duration
- Questionnaire data (see above table)
- End-of-study questionnaire for parents and children about the general experience, tolerability, and feasibility of this method of data collection.
- Proportion of participants with good compliance (> 70%) to study assessments
- Biweekly lung function (FVC, FEV1, PEF)
- Daily blood pressure
- weekly weight and body composition
- Daily smartphone use data (app use, screentime)
Background summary
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.
Study objective
Protocol to establish the intra- and intersubject variability of several wearables and devices in a home-setting.
Protocol to provide control subjects to the studies CHDR1810, CHDR1811.
Study design
Day 1-21
Inclusion criteria
Age 2 to 16 years old
Signing of informed consent form by both parents and when older as 11 child also
Exclusion criteria
Not physically able to wear or use the devices
Evidence or history of chronic lung disease, cardiac disease, neuromuscular disease, diabetes or any other chronic condition that might impair activity level.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7612 |
| CCMO | NL66574.098.18 |
| OMON | NL-OMON48686 |