No registrations found.
ID
Source
Brief title
Health condition
Patients with a doctors-diagnosis of asthma from outpatient clinics and from general practices in the region of London and Manchester in the UK and Leiden in The Netherlands
Sponsors and support
Intervention
Outcome measures
Primary outcome
Asthma Control assessed through the Asthma Control Questionnaire (ACQ)
Secondary outcome
Asthma exacerbations, lung function, FeNO, quality of life, patient utilities, costs, user acceptance
Background summary
DESIGN
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
Study objective
Self-management support by the myAirCoach system as an adjunct to usual care improves asthma control in patients with asthma, compared to usual care.
Study design
Type 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.
Intervention
Usual 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.
Postzone J-10<br>
Postbus 9600
Jacob K. Sont
Leiden 2300 RC
The Netherlands
+31 (0)71 5269111
j.k.sont@lumc.nl
Postzone J-10<br>
Postbus 9600
Jacob K. Sont
Leiden 2300 RC
The Netherlands
+31 (0)71 5269111
j.k.sont@lumc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6944 |
| NTR-old | NTR7200 |
| CCMO | NL62699.058.17 |
| OMON | NL-OMON46602 |