The objective of this study is to evaluate effects of the use of the Pelican instrument in routine medical care for asthmatic children in primary and secondary care.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Asthma-specific health related quality of life of the children as measured with
the Pediatric Asthma Quality of Life Instrument
Secondary outcome
Secondary outcomes are measures of asthma control, asthma medication use, lung
function, NO, asthma symptoms, costs (i.e. program costs, direct medical and
indirect costs), and satisfaction with delivered health care in children as
well as in their parents and physician. Next, facilitators and barriers of
implementation of the Pelican instrument in primary and secondary care are
assessed. To address this, the process of the implementation of the instrument
in both randomised trials will be evaluated. Also the caregivers (i.e.,
parents) health related quality of life is a secondary outcome.
Background summary
Health-related quality of life (HRQL) is the complex of all aspects of an
individual*s subjective experience that relate both directly and indirectly to
health, disease, disability and impairment. Assessment of HRQL for children
with asthma in daily care may facilitate shared decision-making and contribute
to patient-centered care, which could result in improved asthma control, HRQL
and satisfaction with received care. Currently there is no appropriate
pediatric asthma-specific HRQL instrument for use in daily care that is
feasible for daily care. In a recent study we have developed an electronic HRQL
instrument to fill this gap. This so-called *Pelican* instrument is designed as
a webbased computer game.
Study objective
The objective of this study is to evaluate effects of the use of the Pelican
instrument in routine medical care for asthmatic children in primary and
secondary care.
Study design
A 9-month clustered-randomised clinical trial is carried out in general
practice (n=170 children), and a 9-month patient-randomised trial in paediatric
outpatient clinics (n=100 children). Both trials consist of an intervention
group in which physicians use the results of the Pelican instrument in their
provision of asthma care and (b) usual care. All children fill out the Pelican
instrument at 0, 3 and 6 mo, but feed-forward of the outcome is only provided
to intervention group physicians.
Intervention
The intervention in the two studies is the integration of the output of the
Pelican instrument in daily care to guide disease management for children with
asthma.
Study burden and risks
The risk of participation is negligible. The children (and parents) are asked
to fill out questionnaires. Moreover, the fraction of exhaled nitric oxide and
lung function is assessed. For the lung function assessment salbutamol is used.
In general, children with asthma use salbutamol or similar medication to
relieve symptoms. Though very infrequent, the use of salbutamol can result in
some side-effects. If the child has a negative experience with a lung function
test, the test is omitted.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
* age 6 to 12 years
* physician-diagnosed asthma
* child is treated for their asthma by the recruiting physician
* use of inhaled asthma medication for at least six weeks during the previous year
Exclusion criteria
* comorbid condition that significantly influences HRQL
* child does not master the Dutch language sufficiently
* not being able to attend a regular school class
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29895.091.09 |