Home-monitoring of physical activity and vital parameters of pediatric patients following admission due to pneumonia, bronchiolitis or asthma.

Completed

Conditions: asthma
lung disease
10024970

Registration Number: NL-OMON48685

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

1. Signed informed consent from both parents prior to any study-mandated
procedure.
2. Admission to the pediatric ward of Juliana Children*s Hospital, determined
by the attending physician at the time of admission to be due to:
a. Community acquired pneumonia or bronchiolitis (lower respiratory tract
infection) (Age 2-12)
b. Preschool wheezing (Age 2-6)
c. Asthma exacerbation with a previous history of asthma (Age 6-12)

Exclusion Criteria

1. (interstitial) Lung disease other than infection, asthma or preschool
wheezing, cardiac disease, neuromuscular disease, diabetes or any other chronic
condition that is associated with impaired activity level.
2. Children that have a mental or motor impairment.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Physical activity level (step count) during admission, directly after<br /><br>admission and one month after admission. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Hours of sleep and sleep pattern<br /><br>- Mean heart rate during admission and at home, data collected via smartwatch<br /><br>- Daily temperature using Nokia Thermo (children with preschool wheezing and<br /><br>lower respiratory tract infection)<br /><br>- Daily FEV1/PEF/FVC measurements via portable spirometer (patients with asthma)<br /><br>- Daily questions / symptom scores via smartphone app:<br /><br>a. Asthma control diary (ACD) for patients with asthma<br /><br>b. Respiratory symptom scores for patients with pneumonia and bronchiolitis<br /><br>c. Medication use and activity estimation<br /><br>d. Parent-reported recovery<br /><br>- Proportion of patients with good compliance to study tasks, stratified by<br /><br>age- and disease groups.<br /><br>- End-of-study questionnaire for parents and children about the experience and<br /><br>tolerability of this method of data collection. </p><br>