Therefore, the aim of the myAirCoach project is to develop and evaluate technologies that assist patients with asthma. To this purpose we developed a one year observational quantification campaign in which we will identify potentially relevant self-…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The degree to which the various measurements, alone or in combination, can
predict loss of control on asthma during phase one, and the occurrence of
(severe) exacerbations during phase two.
Secondary outcome
- User acceptance of mHealth and home-monitoring systems, as determined by user
adherence to measurements and the After-Scenario Questionnaire (ASQ) feedback
- The influence of seasonality (different seasons) on our primary
parameters/endpoints
Background summary
Asthma is a variable lung condition whereby patients experience periods of
controlled and uncontrolled asthma symptoms. Poor asthma control is associated
with an increased risk of exacerbation, impaired quality of life, increased use
of healthcare services and reduced productivity. Therefore, the ability to
determine and to predict the level of asthma control is useful for patients and
their healthcare teams, and may assist in the management of the condition.
Study objective
Therefore, the aim of the myAirCoach project is to develop and evaluate
technologies that assist patients with asthma. To this purpose we developed a
one year observational quantification campaign in which we will identify
potentially relevant self-monitoring procedures, including sensor devices and
environmental data and we will evaluate their effectiveness in predicting
asthma control.
Study design
Observational study divided in two phases. Patients will be provided with
mHealth and home-monitoring systems. Phase 1 involves one-month of daily
measurements using these systems. Phase 2 is a follow-up phase of 11 months,
with weekly measurements. A further two weeks period of daily monitoring
randomised between 2-9 months will also be conducted in Phase 2, to assess
potential seasonal influences.
Study burden and risks
This is an observational study in which no interventions take place. Therefore
the risks of participation are limited to local side effects of the sensors and
possible anxiety related to the feedback of vital signs. This research
constitutes a considerable burden to patients, especially in phase 1, since it
requires regular measurements and filling in questionnaires. The benefit for
participants will be an increased awareness of relations between deterioration
of asthma and environmental stimuli and bodily signs.
albinusdreef 2
Leiden 2300 RC
NL
albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
* Confirmed diagnosis of asthma by either:
o Reversibility of 12% and/or 200ml in a spirometry
o Peak flow monitoring of one week showing *
o Positive bronchial challenge;* Use of regular asthma treatment, minimal 6 months in the previous year
* Age 18+
* A course of oral prednisone for a minimum of three days, or an emergency department visit/hospitalisation for asthma, in the previous twelve months. Or currently experiencing uncontrolled asthma, based on the result of the Asthma Control Questionnaire
Exclusion criteria
* Well-controlled and without treatment most of the year
* Comorbidities that cause overlapping symptoms such as breathlessness, wheeze, cough or other interfering chronic condition
* Unable to understand English, Dutch
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL54495.058.15 |