Clinical trial NCT03358914: The PsoTeenQOL - Preliminary Reliability and Validity
Official title: The PsoTeenQOL - Preliminary Reliability and Validity of a Health-related Quality of Life Questionnaire for Adolescents With Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: psoriasis, adolescents, quality of life, PRO (patient-reported outcome), validation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Herlev and Gentofte Hospital
name: LEO Pharma
First posted: 2017-12-02
Enrollment: 233
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Examine the psychometric properties of the PsoTeenQOL
timeFrame: Baseline and up to 3 months after first completion of questionnaire package
Secondary outcomes:
measure: Indicators of validity
timeFrame: Baseline
measure: Indicators of reliability
timeFrame: Test-retest: 2 weeks (+/-3 days) after baseline; Responsiveness: 3 months after baseline
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Hilde Randa
role: PRINCIPAL_INVESTIGATOR
References: