|- candidate number||3567|
|- NTR Number||NTR1373|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jul-2008|
|- Secondary IDs||22626 ABR formulier|
|- Public Title||Compliance Objectively measured in a Multicultural Population of children Living In Amsterdam Needing inhaled Corticosteroids for Effective asthma treatment.|
|- Scientific Title||Compliance Objectively measured in a Multicultural Population of children Living In Amsterdam Needing inhaled Corticosteroids for Effective asthma treatment.|
|- hypothesis||The primary aim of this study is to investigate objectively, electronically measured noncompliance to inhaled corticosteroids in a multicultural population of children with asthma. Furthermore, the association of determinants such as ethnicity, age, gender, parental level of education, family income and insurance status with non-compliance will be determined. |
A secondary aim will be the comparison of objectively, electronically measured noncompliance (provided by the RTMEMS technology) to self reported noncompliance as determined with the MARS (Medication Adherence Report Scale) questionnaire.
|- Healt Condition(s) or Problem(s) studied||Asthma, Children, Ethnicity, Inhaled corticosteroids, Compliance|
|- Inclusion criteria||1. Patient is attending the pediatric outpatient department of the St Lucas Andreas Hospital in Amsterdam, AMC or BovenIJ. |
2. ICS use during at least the preceding 6 months using a pMDI.
3. Age of max. 11 years old.
4. Dutch, Turkish or Moroccan ethnicity
|- Exclusion criteria||1. Refusal to participate |
2. Incapability of understanding the RTMEMS instructions. (this exclusion criterium only counts for the electronic measurements)
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-jan-2009|
|- planned closingdate||1-okt-2009|
|- Target number of participants||225|
|- Interventions||None (observational study approach)|
|- Primary outcome||The proportion of noncompliant administrations of the total number of administrations.|
|- Secondary outcome||- The MARS questionnaire data, compared to the RTMEMS as a gold standard.|
- The association of determinants with non-compliance.
|- Timepoints||The study period per patient is 3 months.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. E.C. Vasbinder|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.M.L.A. Bemt, van den|
|- Sponsor/Initiator ||Sint Lucas Andreas Ziekenhuis|
(Source(s) of Monetary or Material Support)
|Longfonds The Netherlands , Agis Health Insurance |
|- Brief summary||The majority of children with asthma in Amsterdam have a non-Dutch background. Data on noncompliance in this group are controversial. Primary aim of this study is to determine objectively measured noncompliance to inhaled corticosteroids (ICS) in a multicultural population of children with asthma in Amsterdam. Objectively means that the data are measured using a reliable, electronic measurement tool, which has never been used before in studies on compliance of inhalation therapy in The Netherlands.
A secondary aim is to compare electronic data on noncompliance with the results of a questionnaire into self reported noncompliance by parent and child. The study is designed as a cross sectional study of 9 months duration, in which the compliance of ICS is measured in a cohort of 150 non-native (75 Turkish, 75 Moroccan) and 75 native Dutch children with asthma (per patient noncompliance is monitored 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). The Medication Adherence Report Scale (MARS) questionnaire 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 paediatric ambulatory clinic, housing and smoking habits of parents. Medication beliefs of parents will be measured using the Beliefs about Medicines Questionnaire (BMQ). Electronically measured noncompliance is the primary outcome measure; the influence of the determinants on noncompliance will be analysed. As a secondary outcome measure the accuracy of the information on noncompliance from the MARS questionnaire will be compared to the RTMEMS. |
The child’s paediatrician will be informed on the study results of his patients, in order to use these data for compliance enhancement. These study results reflect the exact day-to-day use of the ICS by the child.
|- Main changes (audit trail)|
|- RECORD||11-jul-2008 - 9-sep-2010|