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Completed

NCT Number: NCT03358914

The PsoTeenQOL - Preliminary Reliability and Validity

This study aims to develop and provide preliminary reliability and validity of a questionnaire to measure Health-related Quality of Life (HRQOL) in adolescents with psoriasis. To the best of our knowledge, this will be the first psoriasis-specific HRQOL instrument for use in adolescent patients. Data will be collected from a Danish population of adolescents with psoriasis (12-17 years), as well as from parents of adolescents with psoriasis, and a group of adolescents without psoriasis.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University

Aarhus C, 8000, Denmark

About this study

The present study will examine the psychometric properties of a preliminary 41-item version of the PsoTeenQOL. The preliminary PsoTeenQOL has been developed based on qualitative interviews of adolescents (12-17 years) with psoriasis, their parents, and health professionals working within the field, as well as literature reviews and existing questionnaires. Face and content validity has been established through subsequent cognitive interviews with the target group.

Exploratory factor analysis (EFA) and analysis of differential item functioning (DIF) will be used to further refine the PsoTeenQOL questionnaire by selecting the most appropriate items. In addition, indicators of reliability (internal consistency; test-retest reliability), validity (construct validity, criterion validity; discriminant validity), and responsiveness will be evaluated.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Either a) Subjects with psoriasis, b) Parents of adolescents 12-17 years with psoriasis, or c) Subjects without psoriasis
  • Ability to read Danish and complete electronic survey

Exclusion criteria

  • Inability to read Danish and complete electronic survey

Treatment and study plan

No intervention

Other

Completion of surveys

Primary outcomes

  1. Examine the psychometric properties of the PsoTeenQOL

    Time frame: Baseline and up to 3 months after first completion of questionnaire package

    Analyses will include exploratory factor analysis, examination of differential item functioning (DIF) and evaluation of indicators of reliability and validity of the instrument

Secondary outcomes

  1. Indicators of validity

    Time frame: Baseline

    Correlations and comparisons between PsoTeenQOL and similar non-psoriasis-specific instruments (Children's Dermatology Life Quality Index (CDLQI); Pediatric Quality of Life Inventory (PedsQL); WHO-5, proxy- and non-psoriasis control version of the PsoTeenQOL) as well as measures of disease severity (Self-assessed Simplified Psoriasis Index (saSPI), and Psoriasis Area Severity Index (PASI)).

  2. Indicators of reliability

    Time frame: Test-retest: 2 weeks (+/-3 days) after baseline; Responsiveness: 3 months after baseline

    Internal consistencies (Cronbach's alpha), test-retest reliability and responsiveness of the PsoTeenQOL (change scores on the PsoTeenQOL as compared to the CDLQI and disease severity indicators)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Herlev and Gentofte Hospital
  • LEO Pharma

Registry information

Official study title

The PsoTeenQOL - Preliminary Reliability and Validity of a Health-related Quality of Life Questionnaire for Adolescents With Psoriasis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2017
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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