The aim of the proposed study is to conduct an evaluation of the validity of web-based completion of the (Child-) ACT on the basis of comparison with paper-based completion and to test reproducibility of both web-based and paper-based version.…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goal of the present study is to evaluate the concordance of web
version of the ACT and the paper version. Both tests will be performed within a
period of 3-5 days in a randomized order using numbered sealed envelopes
according to a computer generated sequence stratified by centre. This will be
done separately for the two types of ACT (for children 4-11 years and for
children 12 years or above). After the return of a signed informed consent, a
patient study number will be given and the randomisation code will become
available from the corresponding envelope. A logbook will be kept for numbers
of patients not able or willing to participate (specifications: *no computer
available* or *other reasons*).
All statistical analyses will be done separately for the two age groups.
Using Anova for cross-over studies it will be investigated whether differences,
if any, depend on the order of administration of the two versions for the first
and 2nd ACT questionnaire. The agreement between the web version and the paper
version will be quantified by calculating intra-class correlation coefficients.
Graphical presentation of agreement between the 2 versions will be done by
Bland & Altman plots. It is expected that there is a good agreement between
both versions. With a sample size of 75 for each age category, and an observed
correlation coefficient of 0.80, the 95% confidence interval for the
correlation coefficient will range from 0.70 to 0.87. In case of an observed
correlation coefficient of 0.85, the 95% confidence interval for the
correlation coefficient will range from 0.77 to 0.90. These limits are
considered sufficiently narrow. Analyses will be restricted in the first
instance to those children who have stated at the second test that their asthma
has not changed as compared to the day at which they completed the first
assessment.
Similar methods will be used for the comparison of the 2nd and third ACT
assessment within each group (second and third assessment using paper or using
the Web). Primary analysis will focus on patients who have stated at the third
questionnaire that their asthma had not changed since the day of completion of
the previous 2nd questionnaire.
Inclusion for each age category will continue until the target number of 75
evaluable cases for assessment 1 and 2 is met.
Secondary outcome
Acceptance of both versions of the (Child-) ACT will be evaluated by an
additional short questionnaire after the second (Child-) ACT.
Comparison of the results of (Child-) ACT with current recommendations of
control status as defined in GINA guidelines and comparison with a well
validated questionnaire (ACQ) for the children 12 years and older.
Background summary
The Asthma Control Test (ACT) is a simple 5-item questionnaire, which has been
shown useful in the detection of poorly controlled asthma in adults and
children above the age of 12. An ACT-score of 19 or less showed a sensitivity
and specificity of 71% to detect poorly controlled asthma. More recently a
7-item Childhood ACT has been validated in children from the age of four. A
cut-off point of <=19 was selected to indicate uncontrolled asthma (sensitivity
74%, specificity 68%).
Based on epidemiological data, also in Western European countries, still a
substantial proportion of adults as well as children with asthma are not
optimally controlled.
Recently, the newest GINA guidelines for the management of asthma introduced
the level of asthma control as the basis for adjusting asthma medication. Based
on the following characteristics: daytime symptoms, limitations of activities,
nocturnal symptoms, need for reliever medication, lung function and
exacerbations, the patient is categorised as either well controlled, partly
controlled or uncontrolled. This concept of optimizing control status was used
in a worldwide large scale asthma study in 3421 adults and adolescents and
resulted in a large proportion of patients reaching *totally controlled* or
*well-controlled* level. A practical disadvantage of this approach is that for
a correct categorisation of the patient*s control level detailed and continuous
information on symptoms and use of reliever medication are necessary.
Furthermore patients as well as doctors tend to overestimate their level of
asthma control and the effect of medication changes on it. The use of a simple
and valid questionnaire for estimating the level of control and guiding
treatment would overcome these problems. Using modern communication technology
as the internet, a web-based questionnaire may result in improvement of control
status of asthma patients without the need to increase direct contacts between
patients and their physicians. Yet, on the internet children and their parents
are already invited to do the (Child-) ACT and discuss the results with their
doctor.
We therefore state that validation of the web-based version is a necessary step
before using web-based (Child-) ACT in paediatric practice. Furthermore the
Asthma Control Test will be compared with GINA recommendations for asthma
control.
Study objective
The aim of the proposed study is to conduct an evaluation of the validity of
web-based completion of the (Child-) ACT on the basis of comparison with
paper-based completion and to test reproducibility of both web-based and
paper-based version. Additionally, patients* subjective evaluation of the
acceptability will be explored.
For children aged 4 to 11 years old the Children Asthma Control Test will be
performed, for children from the age of 12 to 18 years old the Asthma Control
Test will be performed.
A secundary objective of this study is to compare the results of the Asthma
Control Test with the current recommendations on asthma control by GINA
guidelines and to compare the resulst of the Asthma Control Test in children 12
years and older with the Asthma Control Questionnaire by Juniper.
Study design
Randomised cross-over design of a paper and webbased version of the (Child-)ACT
followed by a repeat (Child-)ACT of the last version (either paper or
webbased). After the second (Child-)ACT an additional questionnaire on
acceptance will be sent.
Children will be recruited from the outpatient departments of the participating
centres. Children and/or parents will receive an information sheet and consent
form upon their regular visit to their paediatrician/paediatric pulmonologist.
At that visit the aim and impact of the study will be explained. If necessary,
additional information can be obtained by a telephone call to the
paediatrician/paediatric pulmonologist or specialised paediatric asthma nurse.
For practical reasons, children and/or parents are asked to return the consent
form by postage free envelope, either signed if they agree to participate or
unsigned if they are not willing to participate.
Randomisation will be stratified by centre and age-group (4-11 or 12-18), using
a random numbers list with either code A (paper- web) or B (web - paper) for
each number. Codes are placed in sealed numbered envelopes and for the separate
age groups supplied to each centre. After the return of a signed informed
consent, a patient study number will be given and the randomisation code will
become available from the corresponding envelope.
Study scheme
Upon receipt of a signed informed consent, depending on randomisation, either
a paper-based (Child-)ACT will be sent by post or an invitation by mail will be
sent to fill in the web-based (Child-)ACT. The paper-based (Child-) ACT has to
be returned in a postage free envelope. Upon receipt of either the paper-based
or web-based questionnaire, the opposite version will be sent out, according to
the cross-over design. Before answering this second (Child-) ACT patients will
be asked whether their asthma is unchanged, improved or worsened compared to
the time at which they answered the first (Child-) ACT. One week after receipt
of both versions of the (Child-) ACT either a paper-based or web-based (Child-)
ACT will be sent, conform the latest version of the (Child-) ACT, also
beginning with the question whether their asthma has changed during the last
week. Furthermore, the questionnaire on acceptance will be sent. Active
guidance by specialised paediatric asthma nurses will take place in order to
receive both versions of the questionnaire within a time span of preferably 5
days.
For the second part of the study, patients will be sent an web-based diary card
upon receipt of their (re-test) (Child-) ACT. Data can be submitted up to 2
days later. After completion of this 4-week diary card another (Child-) ACT
will be sent webbased and ACQ for children 12 years and older.
Study burden and risks
The time for completion of the ACT as well as the Child ACT is maximum 5-10
minutes.
The 4-week webbased diary will take maximum 2-5 minutes per day. Data can be
filled in up to 2 days later.
Postbus 90157
4800 RL Breda
Nederland
Postbus 90157
4800 RL Breda
Nederland
Listed location countries
Age
Inclusion criteria
age 4-18 years
asthma
internet access
ability to understand Dutch language
Exclusion criteria
chronic lung disease, other than asthma
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 | NL22725.101.08 |