The PsoTeenQOL – Preliminary Reliability and Validity

Overview

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.

Full Title of Study: “The PsoTeenQOL – Preliminary Reliability and Validity of a Health-related Quality of Life Questionnaire for Adolescents With Psoriasis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 15, 2019

Detailed Description

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.

Interventions

  • Other: No intervention
    • Completion of surveys

Arms, Groups and Cohorts

  • Adolescents with psoriasis
    • No assigned intervention: completion of PsoTeenQOL and other instruments for assessment of psychometric properties and further refinement of the PsoTeenQOL.
  • Parents of adolescents with psoriasis
    • No assigned intervention: completion of proxy-version of the PsoTeenQOL for validation purposes
  • Adolescents without psoriasis
    • No assigned intervention: completion of non-psoriasis control-version of the PsoTeenQOL for validation purposes

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)).
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 17 Years

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Collaborator
    • Herlev and Gentofte Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hilde Randa, Principal Investigator, University of Aarhus

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