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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48686

Enrollment

150

Registered

2018-10-08

Start date

2018-11-29

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alternatieve methode voor vitale functie metingen bij kinderen children Healthy subjects

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
- Daily step count	—

Secondary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

—

Countries

Netherlands

Outcome results