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Evaluatie van het myAirCoach zelf-management ondersteuningssysteem voor mensen met astma in vergelijking met gebruikelijke zorg: een pragmatisch gerandomiseerd onderzoek (myAirCoach: evaluation campaign).


- candidate number28875
- NTR NumberNTR7200
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mei-2018
- Secondary IDsNL62699.058.17 ABR62699
- Public TitleEvaluatie van het myAirCoach zelf-management ondersteuningssysteem voor mensen met astma in vergelijking met gebruikelijke zorg: een pragmatisch gerandomiseerd onderzoek (myAirCoach: evaluation campaign).
- Scientific TitleEvaluation of myAirCoach self-management support compared with usual care in asthma: a pragmatic randomized controlled trial
- ACRONYMmyAirCoach EC
- hypothesisSelf-management support by the myAirCoach system as an adjunct to usual care improves asthma control in patients with asthma, compared to usual care.
- Healt Condition(s) or Problem(s) studiedAsthma, Diagnosis, General practitioner, Outpatient clinics
- Inclusion criteria Age 18+
Clinician diagnosis of asthma
Asthma treatment step 2-5 - need for regular controller medication (≥6 months of the year), this equates to 2 or more ICS prescriptions per year
Poor asthma control (ACQ>0.75) and/or one-or-more exacerbations or hospital visit in the previous year due to asthma
Ownership of a mobile phone compatible with the myAirCoach system
- Exclusion criteria Unable to understand English or Dutch, as appropriate
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-feb-2018
- planned closingdate16-mrt-2019
- Target number of participants90
- InterventionsUsual care group
Patients in the usual care group will be provided with regular (face-to-face) care with their health care professionals.

myAirCoach group
In addition to usual care patients in the myAirCoach group will be provided with self-management support via the myAirCoach system. This system consists of the several devices and mHealth and web-applications for patients as well as a web-application for health care professionals.
- Primary outcomeAsthma Control assessed through the Asthma Control Questionnaire (ACQ)
- Secondary outcomeAsthma exacerbations, lung function, FeNO, quality of life, patient utilities, costs, user acceptance
- TimepointsType of study: Multi-centre, pragmatic randomized controlled trial, in which participants will be randomized in a 1:1 ratio to myAirCoach self-management support as an adjunct to usual care (myAirCoach group) or to usual care alone (usual care group).
Duration: 3-9 months (staggered enrolment with variable follow-up duration). A sequential phased study so that patients will therefore be involved for a minimum 3 months, up to a maximum 9 months.
- Trial web sitewww.myaircoach.eu
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jacob K. Sont
- CONTACT for SCIENTIFIC QUERIES Jacob K. Sont
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
European Union Horizon 2020 Research and Innovation Programme
- Publications
- Brief summaryDESIGN
Multi-centre, pragmatic randomized control trial
AIMS
To assess the myAirCoach system in a real life environment and determine whether it provides clinical benefit (improvements in asthma control) to patients with asthma.
OUTCOME MEASURES
Primary: Asthma Control (assessed through the ACQ)
Secondary: Lung function, asthma exacerbation, quality of life, Symptoms, costs
POPULATION
Maximal 60 subjects in the Netherlands, minimal 30 subjects in the UK, 90 subjects in total
ELIGIBILITY
Adult patients with uncontrolled asthma
TREATMENT
myAirCoach intervention
DURATION
3-9 months (variable follow-up length); A sequential phased study so that patients will therefore be involved for a minimum 3 months, up to a maximum 9 months
- Main changes (audit trail)
- RECORD2-mei-2018 - 13-mei-2018


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