Primary aim is to study electronically measured compliance to inhaled corticosteroids (ICS) in a multicultural population of children with asthma in Amsterdam. A secondary aim will be to compare electronical data on compliance with parent reports.
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Electronically measured compliance is the primary outcome measure; the
influence of the determinants on compliance will be analysed.
Secondary outcome
As a secondary outcome measure the accuracy of the information on compliance
from the questionnaire will be compared to the RTMEMS.
Background summary
Non-compliance is a major issue in asthma treatment. Ethnic minorities have an
increased risk of poor asthma control. The majority of children with astma in
Amsterdam have a non-Dutch background. However, data on compliance in this
group are controvertial.
Study objective
Primary aim is to study electronically measured compliance to inhaled
corticosteroids (ICS) in a multicultural population of children with asthma in
Amsterdam. A secondary aim will be to compare electronical data on compliance
with parent reports.
Study design
The study is designed as a cross sectional study in which the compliance of ICS
is measured in a cohort of 75 Turkish, 75 Moroccan and 75 Dutch children with
asthma during 3 months. Objective measurements of compliance will be performed
using a pressurized Metered-Dose Inhaler (pMDI) connected to a Real Time Remote
Medication Event Monitoring System (RTMEMS). Questionnaires will be used to
investigate self reported compliance. Determinants to be registered include
age, gender, ethnicity, language skills, parental level of education, family
income, hospitalisation rates, frequency of visits to the pediatric ambulatory
clinic, medication beliefs of parents, housing and smoking habits of parents.
Study burden and risks
In this study patients are asked to participate in 2 interviews and to use a
pressurized Metered-Dose inhalator connected to RMEMS, that is supplied by the
investigators and which contains their usual inhaled corticosteroid for 3
months. There isn't any therapeutic intervention in this observational study.
Apart from an initial telephone call, patients visit the hospital twice in a
three month period. The interviews mentioned above, take place during these
visits. For the majority of the participating patients this approximates their
regular frequency of visiting the pediatric outpatient clinic.
Jan Tooropstraat 164
1061 AE
Nederland
Jan Tooropstraat 164
1061 AE
Nederland
Listed location countries
Age
Inclusion criteria
- Patient attending the pediatric outpatient department of the St. Lucas Andreas hospital or the Academic Medical Centre.
- Patient has been treated with fluticason for at least 3 months using a pressurized metered-dose inhaler.
- Maximum age: 11 years old.
- Dutch, Moroccan, Turkish ethnicity.
Exclusion criteria
- Patient refuses to participate in the study.
- Patient is not capable of using the equipment for electronic measurement of compliance correctly#.;#These patient are requested to participate in the interview. In addition, patient characteristics are collected to investigate whether these patients differ from the ones that are capable of using the RTMEMS-equipment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 3567 (Nederlands Trial Register) |
| CCMO | NL22626.029.08 |