Validation of the Dutch Language Asthma Control Test (ACT) and Child-ACT for internet use among adolescents (ACT) and parents and children (Child-ACT)

Validation of the Dutch Language Asthma Control Test (ACT) and Child-ACT for internet use among adolescents (ACT) and parents and children (Child-ACT) - geen

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31860

Enrollment

150

Registered

2008-07-15

Start date

2008-11-10

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: age 4-18 years asthma internet access ability to understand Dutch language

Exclusion criteria

Exclusion criteria: chronic lung disease, other than asthma

Design outcomes

Primary

Measure	Time frame
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 (seco	—

Measure

Time frame

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 (seco

—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results