Home-monitoring in pediatric chronic disease
- Conditions
- Severe overweight, fatigue, sickle cell disease, asthma, cystic fibrosis
- Registration Number
- NL-OMON21018
- Lead Sponsor
- .A. (Collaboration Juliana Children’s Hospital & CHDR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
General
1. Signed informed consent from both parents or the legal guardian prior to any study-mandated procedure.
2. Patients undergoing treatment in the outpatient clinic of Juliana Children’s Hospital.
3. Age 6-16
Arm A.
- Patients are referred by their general practitioner due to complaints of general malaise, fatigue or tiredness.
Arm B.
- Patients are diagnosed with obesity
Arm C.
- Patients are diagnosed with sickle cell disease
Arm D.
- Patients are treated for cystic fibrosis or
- Patients have controlled or difficult to control asthma at the time of inclusion.
o Difficult to control asthma defined by Asthma Control Questionnaire cutoff score of 1.5 or
fulfilling = 3 Global Initiative for Asthma (GINA) criteria for partly/uncontrolled asthma
1. Evidence or history of lung disease, cardiac disease, neuromuscular disease, diabetes or any other chronic
condition other than the studied disease, that might impair activity level.
2. Children that have a mental and/or motor impairment.
3. Inability to wear or use the wearable device.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Daily physical activity level (step count)
- Secondary Outcome Measures
Name Time Method