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| Name | Class |
|---|---|
| Herlev and Gentofte Hospital | OTHER |
| LEO Pharma | INDUSTRY |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Adolescents without psoriasis | No assigned intervention: completion of non-psoriasis control-version of the PsoTeenQOL for validation purposes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Completion of surveys |
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| Measure | Description | Time Frame |
|---|---|---|
| Examine the psychometric properties of the PsoTeenQOL | Analyses will include exploratory factor analysis, examination of differential item functioning (DIF) and evaluation of indicators of reliability and validity of the instrument | Baseline and up to 3 months after first completion of questionnaire package |
| Measure | Description | Time Frame |
|---|---|---|
| Indicators of validity | 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)). |
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Inclusion Criteria:
Exclusion Criteria:
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To achieve maximum variation in participant demographic and clinical characteristics, eligible participants with psoriasis plus their parents will be identified through several sites; a) the Danish Psoriasis Association, b) the National Danish Birth Cohort, and c) all five tertiary hospital clinics in Denmark. All adolescents without psoriasis will be recruited from the National Danish Birth Cohort.
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| Name | Affiliation | Role |
|---|---|---|
| Hilde Randa | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University | Aarhus C | 8000 | Denmark |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Baseline |
| Indicators of reliability | 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) | Test-retest: 2 weeks (+/-3 days) after baseline; Responsiveness: 3 months after baseline |