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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2583 |
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Date of registration:
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02/11/2010 |
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Primary sponsor: |
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Public title:
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e-Monitoring of Asthma Therapy to Improve Compliance in children.
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Scientific title:
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The use of a Real-Time Medication Monitoring system (RTMM) for the improvement of adherence to inhalation corticosteroids in children with asthma. - e-MATIC |
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Date of first enrolment:
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1/1/2011 |
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Target sample size:
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220 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2583 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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E.C.
Vasbinder |
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Address:
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Erasmus MC
Afdeling apotheek
Cluster 7
Postbus 2040
3000 CA
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 7033202 |
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Email:
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erwinvasbinder@gmail.com |
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Affiliation:
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Name:
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P.M.L.A.
Bemt, van den |
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Address:
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Utrecht University
Faculty of Science - Utrecht Institute for Pharmaceutical Sciences - Division of Pharmacoepidemiology & Pharmacotherapy
PO Box 80 082
3508 TB
Utrecht
The Netherlands |
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Telephone:
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+31 (0)30 2534042 |
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Email:
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p.vandenbemt@uu.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Children younger than 12 years old;
2. Diagnosed with asthma for at least 6 months;
3. ICS use for at least 3 months using a pMDI;
4. At least one parent or care giver has a mobile phone.
Exclusion criteria: Refusal to participate in the study.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Asthma, Inhaled corticosteroids, Compliance, Real time medication monitoring (RTMM), Text-messaging reminder
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Intervention(s)
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All children will receive a real time medication monitoring (RTMM) device that is connected to the pressurized metered dose inhaler (pMDI) with inhaled corticosteroids (ICS). Immediately after each inhalation, a signal is sent to the research database. This information is compared to the expected time of inhalation and thus adherence is determined. Only in the intervention group, sms-reminders are sent to parents of children that are at risk of forgetting to take their ICS.
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Primary Outcome(s)
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Percentage of inhalations taken within a 6 hour timeframe around the expected time of inhalation.
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Secondary Outcome(s)
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1. Asthma controll;
2. Asthma exacerbations;
3. Disease specific quality of life;
4. Acceptance of e-monitoring bij parents and children.
Moreover, an economic evaluation will be performed adopting a societal perspective, including all relevant healthcare costs and productivity loss of the parents.
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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