The PsoTeenQOL - Preliminary Reliability and Validity

NCT ID: NCT03358914

Last Updated: 2019-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-20

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adolescents with psoriasis

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

No intervention

Intervention Type OTHER

Completion of surveys

Parents of adolescents with psoriasis

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

No intervention

Intervention Type OTHER

Completion of surveys

Adolescents without psoriasis

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

No intervention

Intervention Type OTHER

Completion of surveys

Interventions

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No intervention

Completion of surveys

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev and Gentofte Hospital

OTHER

Sponsor Role collaborator

LEO Pharma

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hilde Randa

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Aarhus University

Aarhus C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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HRQOL hos unge med psoriasis

Identifier Type: -

Identifier Source: org_study_id

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