Protocol for gathering data for the pediatric control groups of various CHDR trial@home studies with wearable technology and smart-phone applications.
Completed
- Conditions
- Alternatieve methode voor vitale functie metingen bij kinderenchildrenHealthy subjects
- Registration Number
- NL-OMON48686
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Daily step count</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Baseline information: including age, weight, length, school and city<br /><br>- Daily heart rate data<br /><br>- Biweekly temperature<br /><br>- Daily sleep duration<br /><br>- Questionnaire data (see above table)<br /><br>- End-of-study questionnaire for parents and children about the general<br /><br>experience, tolerability, and feasibility of this method of data collection.<br /><br>- Proportion of participants with good compliance (> 70%) to study assessments<br /><br>- Biweekly lung function (FVC, FEV1, PEF)<br /><br>- Daily blood pressure<br /><br>- weekly weight and body composition<br /><br>- Daily smartphone use data (app use, screentime) </p><br>