Home-monitoring of disease activity in pediatric chronic disease. - Home-monitoring in pediatric chronic disease

Centre for Human Drug Research0 个研究点目标入组 180 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

Trial ended prematurely

•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
•- Patients are referred by their general practitioner due to complaints of
•general malaise, fatigue or tiredness.
•- Patients are diagnosed with obesity
•- Patients are diagnosed with sickle cell disease
•- Patients are treated for cystic fibrosis or
•- Patients have controlled or difficult to control asthma at the time of
•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 (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.

发起方