R06.2 J45
Conditions
Interventions
Group 1: Use of a digital wheeze detector in a home care setting in addition to regular clinical care according to current international and national guidelines. Symptom and medication recording via s
Sponsors
Charité Campus Virchow-Klinikum
Eligibility
Sex/Gender
All
Age
4 Months to 72 Months
Inclusion criteria
Inclusion criteria: 1) at least one episode of doctor´s diagnosed wheezing and/or recurrent cough requiring treatment according to GINA guidelines steps 1 and 2 in the last 12 months; 2) age between 4 and 72 months; 3) sufficient comprehension of the local language (German, Dutch, English); 4) availability of a smart-phone (Android or iOS); 5) consensus to participation.
Exclusion criteria
Exclusion criteria: 1) anatomic malformation causing a chronic nasal and/or bronchial obstruction; 2) severe chronic disease; 3) severity of wheezing disorder requiring treatment according to GINA guidelines step 3 or higher; 4) intention to move away from the local study center during the monitoring period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary hypothesis of the study is, that the control of preschool wheezing can be improved using a digital wheeze detector in a home care setting for wheezing children aged 4 to 72 months. The primary outcome is the score of validated TRACK questionnaire after 3 months compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary hypotheses (SH) are, that the use of a digital wheeze detector will… SH1 …improve parental self-efficacy in the management of wheezing and/or asthma SH2 …improve the parental quality of life SH3 …improve the child´s quality of life SH4 ...affect the use of reliever and anti-inflammatory medication SH5 …be easy for parents without the need of specific educational training modules. Secondary outcomes (SO) of the present study are: SO1: Parental Asthma Management Self-Efficacy Score (PAMSES) after 3 months SO2: Pediatric Asthma Caregiver's Quality of Life Questionnaire after 3 months SO3: TNO-AZL Preschool Children Quality of Life after three months SO4: frequency of reliever medication use recorded in the e-diary during three months SO5: Usability questionnaire after three months of use | — |
Countries
Germany, Netherlands, Turkey, United Kingdom
Contacts
Public ContactStephanie Dramburg
Klinik für Pädiatrie mit Schwerpunkt Pneumologie, Immunologie und Intensivmedizin, Charité Universitätsmedizin - Berlin
Outcome results
None listed