The use of a Real Time Medication Monitoring system (RTMM) for the improvement of adherence to inhaled corticosteroids in children with asthma.
- Conditions
- asthma10046304
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
* children 4-11 years old
* diagnosed with asthma for at least 6 months
* ICS use for at least 3 months using a pMDI
* at least one parent or care giver has a mobile phone
Exclusion Criteria
* patient resisting participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure is defined as the number of prescribed dosages taken by<br /><br>the child in the correct timeframe (from 3 hours before untill 3 hours after<br /><br>the planned moment of inhalation)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are asthma control, healthcare use and<br /><br>disease-specific quality of life collected through questionnaires, interviews<br /><br>and medical health records. Online focus groups and patient questionnaires will<br /><br>be used to collect data on parental and children*s acceptance of the RTMM<br /><br>system.<br /><br>An economic evaluation will be performed adopting a societal perspective,<br /><br>including all relevant healthcare costs and productivity loss of the parents.<br /><br>Furthermore, we will develop a decision-analytic model that includes different<br /><br>levels or forms of adherence and the outcomes, both clinical and costs,<br /><br>attributed to each level or form of adherence as well as different price levels<br /><br>for RTMM.</p><br>