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The PsoTeenQOL - Preliminary Reliability and Validity

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ClinicalTrials.gov Identifier: NCT03358914
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
Herlev and Gentofte Hospital
LEO Pharma
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment
Psoriasis Other: No intervention

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.


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Study Type : Observational
Actual Enrollment : 233 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The PsoTeenQOL - Preliminary Reliability and Validity of a Health-related Quality of Life Questionnaire for Adolescents With Psoriasis
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort Intervention/treatment
Adolescents with psoriasis
No assigned intervention: completion of PsoTeenQOL and other instruments for assessment of psychometric properties and further refinement of the PsoTeenQOL.
Other: No intervention
Completion of surveys

Parents of adolescents with psoriasis
No assigned intervention: completion of proxy-version of the PsoTeenQOL for validation purposes
Other: No intervention
Completion of surveys

Adolescents without psoriasis
No assigned intervention: completion of non-psoriasis control-version of the PsoTeenQOL for validation purposes
Other: No intervention
Completion of surveys




Primary Outcome Measures :
  1. Examine the psychometric properties of the PsoTeenQOL [ Time Frame: Baseline and up to 3 months after first completion of questionnaire package ]
    Analyses will include exploratory factor analysis, examination of differential item functioning (DIF) and evaluation of indicators of reliability and validity of the instrument


Secondary Outcome Measures :
  1. Indicators of validity [ Time Frame: Baseline ]
    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)).

  2. Indicators of reliability [ Time Frame: Test-retest: 2 weeks (+/-3 days) after baseline; Responsiveness: 3 months after baseline ]
    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)



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358914


Locations
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Denmark
Aarhus University
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Herlev and Gentofte Hospital
LEO Pharma
Investigators
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Principal Investigator: Hilde Randa University of Aarhus

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03358914     History of Changes
Other Study ID Numbers: HRQOL hos unge med psoriasis
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Aarhus:
psoriasis, adolescents, quality of life, PRO (patient-reported outcome), validation

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases