The PsoTeenQOL - Preliminary Reliability and Validity

Completed

• Conditions: Psoriasis
• Interventions: Other: No intervention

• Registration Number: NCT03358914
• Lead Sponsor: University of Aarhus

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-02
• Study Start: 2018-02-20
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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

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Exclusion Criteria

• Inability to read Danish and complete electronic survey

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adolescents without psoriasis	No intervention	No assigned intervention: completion of non-psoriasis control-version of the PsoTeenQOL for validation purposes
Adolescents with psoriasis	No intervention	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 intervention	No assigned intervention: completion of proxy-version of the PsoTeenQOL for validation purposes

Primary Outcome Measures

Name	Time	Method
Examine the psychometric properties of the PsoTeenQOL	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 Outcome Measures

Name	Time	Method
Indicators of reliability	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)
Indicators of validity	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)).

Trial Locations

Locations (1)

Aarhus University; 🇩🇰 Aarhus C, Denmark