The PsoTeenQOL - Preliminary Reliability and Validity

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 12 Years - 17 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03358914
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Aarhus
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hilde Randa
Principal Investigator Affiliation University of Aarhus
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

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.

Contact a Trial Team

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International Sites

Aarhus University, Aarhus C, Denmark

Status

Recruiting

Address

Aarhus University

Aarhus C, , 8000

Site Contact

Hilde Randa

hilderanda@psy.au.dk

004587165879

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