The PsoTeenQOL - Preliminary Reliability and Validity

University of Aarhus

Status: Completed

Conditions: Psoriasis

Treatments: Other: No intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03358914

HRQOL hos unge med psoriasis

Details and patient eligibility

About

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 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.

Enrollment: 233 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

233 participants in 3 patient groups

Adolescents with psoriasis

Description:

No assigned intervention: completion of PsoTeenQOL and other instruments for assessment of psychometric properties and further refinement of the PsoTeenQOL.

Treatment:

Other: No intervention

Parents of adolescents with psoriasis

Description:

No assigned intervention: completion of proxy-version of the PsoTeenQOL for validation purposes

Treatment:

Other: No intervention

Adolescents without psoriasis

Description:

No assigned intervention: completion of non-psoriasis control-version of the PsoTeenQOL for validation purposes

Treatment:

Other: No intervention