The objective of this project is to establish the validity, reliability and responsiveness of a self-administered electronic asthma-specific quality of life instrument for childhood asthma. Since the Pelican instrument is developed to evaluate HRQL…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Pelican instrument should have the following (clinimetric) characteristics:
has a high internal consistency and is able to detect relevant changes in HRQL
within an individual child aged 6 to 12 years (evaluative capacity of the
instrument). Moreover, the validity of the individualised part of the
instrument should be good and the instrument is comprehendible, serviceableness
and acceptable according to the children.
Secondary outcome
The Pelican instrument should have the following (clinimetric) characteristics:
is able to discriminate between relevant groups; is valid based on
cross-sectional construct validity; is reliable and valid for children with
asthma aged 4 or 5. Next the influence of a reminder on the reliability of the
children*s answers will be evaluated.
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 improvement adherence to
treatment, 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 project is to establish the validity, reliability and
responsiveness of a self-administered electronic asthma-specific quality of
life instrument for childhood asthma. Since the Pelican instrument is developed
to evaluate HRQL in daily care it is especially important that the Pelican
instrument is able to detect relevant changes in HRQL within a child.
Study design
Clinimetric study (no intervention) with a follow up of 2-months for asthmatic
children (3 visits) and one visit for the reference population.
Study burden and risks
Minors are asked to participate in this non-therapeutic trial. Since the
Pelican-instrument is an instrument developed to assess the HRQL of asthmatic
children, it is not possible to use other subjects (like adults). The results
of this trial could result in benefits for children with asthma in general. 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.
Postbus 9101
6500 HB
Nederland
Postbus 9101
6500 HB
Nederland
Listed location countries
Age
Inclusion criteria
For the asthmatic children
* age 4 to 12 years
* signed informed consent by parent (or caretaker)
* child agrees to participate in the study
* at least two prescriptions for inhaled asthma medication during the previous year
* use of inhaled asthma medication for at least six weeks during the previous year
* physician-diagnosed asthma (a symptom diagnose asthma by a physician in case the child is 4 or 5 years old ) ;For the healthy individuals (reference population)
* age 6 to 12 years
* signed informed consent by parents (or caretakers)
* child agrees to participate in the study
Exclusion criteria
For all children
* 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 | NL23004.091.08 |