Trial document





This trial has been registered retrospectively.
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  DRKS00006326

Trial Description

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Title

Kids-CAT: Development and Validation of the first German-speaking Computer-Adaptive Test (CAT) for the assessment of Health-Related Quality of Life (HRQOL) in healthy and chronically ill children and adolescents.

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Trial Acronym

Kids-CAT

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URL of the Trial

http://kids-cat.org

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Brief Summary in Lay Language

The Kids-CAT project is funded by the German Ministry of Research and Education. The aim of this study is the development of a new and innovative computer test for the assessment of the health-related quality of life in healthy children and adolescents and in children and adolescents suffering from asthma, arthritis or diabetes.
One important objective of the study is to evaluate the feasibility of the Kids-CAT in pediatric routine care. Furthermore, the influences of the implementation of the Kids-CAT into routine care on the patient care process (e.g. improvement of physician-patient-communication) will be investigated.
In addition we are interested in the well-being of children and adolescents suffering from a chronical condition, how they think about their health, and how they can cope better with their condition. The data will be compared to data from healthy school children and adolescents from Hamburg.
The project period of the Kids-CAT study is three years (2012-2015) and the study is being conducted at two University Medical Centers in Kiel and in Luebeck.

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Brief Summary in Scientific Language

Background:
Patient-reported outcomes in addition to medical endpoints are becoming increasingly important in directing and evaluating medical treatment. Health-related quality of life (HRQOL) measurement appears to be useful in identifying children with the greatest health care needs and providing timely, targeted interventions. The Kids-CAT project develops a computer-adaptive test (CAT) in order to assess the HRQOL of chronically ill children and adolescents in an efficient, precise and valid way.
Computer-adaptive testing (CAT) is a method that allows to select the most informative item from an item bank for every individual patient according to his or her degree of the underlying latent trait, and to administer only those items. That way, computer adaptive testing achieves the higher precision needed for individual patient measurement. The advantages of CAT measurements compared to traditional paper-pencil-questionnaires include increased measurement precision and reduced response burden.

The Kids-CAT project has the following objectives:
1. Development of the first German-speaking computer-adaptive HRQOL instrument (the Kids-CAT) for children and adolescents (with a focus on making it precise, user-friendly in design and administration and easy-to-understand)
2. Longitudinal assessment of reliability and validity of the HRQOL-CAT among children and adolescents with asthma, arthritis and diabetes
3. Collection of norm data in healthy children and adolescents in a school-based survey
4. Further objectives are the implementation of the HRQOL-CAT in routine care and to test its feasibility and influences on the patient care process (e.g. investigating the user-friendliness & effects on the communication between pediatrician and child)

Methods:
1. Development of the Kids-CAT:
The development of the Kids-CAT is based on large archived data sets from German and international health surveys on children and adolescents (e.g. KIDSCREEN, Bella and DISABKIDS). The item selection process for the item banks of the Kids-CAT was performed using methods derived from classical test theory and item response theory.
2. Evaluation of reliability and validity of the Kids-CAT:
The recruitment of children and adolescents suffering from asthma, arthritis or diabetes took place in two University Medical Centers. Longitudinal assessment of the Kids-CAT and a further comparison with well-established quality of life instruments evaluates reliability and validity.
3. Collection of norm data: The Kids-CAT is conducted with healthy children and adolescents in a school-based survey, which is partially longitudinally.
4. Further objectives: A further objective is to conduct focus groups with children and adolescents on the one hand and physicians on the other hand to evaluate feedback concerning user-friendliness, feasibility and implementation of the Kids-CAT in pediatric routine care.

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Organizational Data

  •   DRKS00006326
  •   2014/08/01
  •   [---]*
  •   yes
  •   Approved
  •   [---]*, Psychotherapeutenkammer Hamburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E14 -  Unspecified diabetes mellitus
  •   J40-J47 -  Chronic lower respiratory diseases
  •   M05-M14 -  Inflammatory polyarthropathies
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Interventions/Observational Groups

  •   1. Development of a computer-adaptive test (CAT) for the assessment of the health-related quality of life in children and adolescents
    2. Chronically ill children and adolescents suffering from asthma, arthritis or diabetes and their parents were asssessed with the Kids-CAT and several well established quality of life instruments at the beginning of the study, after 3, 6 and partially also after 12 months.
    3. Collection of norm data: The Kids-CAT is conducted with 1200 children and adolescents in a school-based survey, which is partially longitudinally.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

(1) The development of a computer-adaptive test (CAT) assessing health-related quality of life (HRQOL) for children and adolescents
(2) The assessment of reliability (internal consistency reliability with Cronbach
alpha) and validity (factorial validity by confirmatory factor analyses; construct validity by correlations of the Kids-CAT with other well established quality of life instruments, e.g. the Peds-QL, Kidscreen-27 and Kindl-R) of the HRQOL-CAT among children and adolescents with asthma, arthritis and diabetes
(3) To collect norm data in healthy children and adolescents

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Secondary Outcome

Implementation of the HRQOL-CAT in routine care to test its feasibility and
influences on the patient care process (e.g., physician-patient-communication).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/06/18
  •   1500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   7   Years
  •   17   Years
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Additional Inclusion Criteria

Clinical sample: The participant must be diagnosed with asthma, arthritis, or diabetes based on ICD-10.
Both parent and child must enrol in the study together and be able to listen, speak, and read German.
Both children/adolescents and parents must consent to the study participation by completing and signing an informed consent form prior to study participation.

School-based sample: Parents must consent to the study participation by completing and signing an informed consent form prior to study participation.
Child must be able to listen, speak, and read German.

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Exclusion Criteria

/

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Klinik für Kinder- und Jugendmedizin LübeckUniversitätsklinikum Schleswig-Holstein Campus Lübeck
    • Ms.  Prof. Dr.  Ute  Thyen 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    •   +49 451 500 2615
    •   +49 451 500 6222
    •   Ute.Thyen at uksh.de
    •   [---]*
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    • Klinik für Allgemeine PädiatrieUniversitätsklinikum Schleswig-Holstein Campus Kiel
    • Mr.  Dr.  Marcus  Klein 
    • Schwanenweg 20
    • 24105  Kiel
    • Germany
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    • Medizinische Klinik mit Schwerpunkt PsychosomatikCharité - Universitätsmedizin Berlin
    • Mr.  PD Dr.  Matthias  Rose 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Institut für Psychologie Lehrstuhl Gesundheit + PräventionErnst-Moritz-Arndt-Universität Greifswald
    • Ms.  Prof. Dr.  Silke  Schmidt 
    • Robert-Blum-Str. 13
    • 17487  Greifswald
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf Klinik für Kinder- und Jugendpsychiatrie, -psychotherapie und -psychosomatikForschungssektion „Child Public Health“
    • Ms.  Prof. Dr.  Ulrike  Ravens-Sieberer 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-EppendorfKlinik für Kinder- und Jugendpsychiatrie, -psychotherapie und -psychosomatikForschungssektion „Child Public Health“
    • Ms.  Dipl.-Psych.  Dana  Barthel 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • Hannoversche Straße 28-30
    • 10115  Berlin
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Status

  •   Recruiting complete, follow-up complete
  •   2014/10/31
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Trial Publications, Results and other Documents

  •   Devine, J., Otto, C., Rose, M., Barthel, D., Fischer, F., Mühlan, H., Nolte, S., Ottova-Jordan, V. & Ravens-Sieberer, U. (2014). A new computerized adaptive test advancing the measurement of health-related quality of life (HRQoL) in children: the Kids-CAT. Quality of Life Research, 1-14. doi: 10.1007/s11136-014-0812-7
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* This entry means the parameter is not applicable or has not been set.