Home-monitoring of disease activity in pediatric chronic disease.

Completed

• Conditions: obesity, chronic fatigue; asthma; cystic fibrosis; fatigue; severe overweight; sickle cell disease; 10005330; 10006436

• Registration Number: NL-OMON48867
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-01-11
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

General
1. Signed informed consent from both parents or the legal guardian prior to any
study-mandated procedure and from subjects aged older than 11 years old.
2. Patients undergoing treatment by a pediatrician
3. Age 6-16 years for subjects in arm A, B and D. Age 5-17 for subjects in arm
C., 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

Exclusion Criteria

1. Evidence or history of lung disease, cardiac disease, neuromuscular disease,
diabetes (excluding: CF-associated diabetes in arm D, diabetes type 2
associated with obesity in arm B) 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
<p>- Daily physical activity level (step count)</p><br>