NCT03358914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

October 13, 2017

Last Update Submit

April 23, 2019

Conditions

Psoriasis

Keywords

psoriasis, adolescents, quality of life, PRO (patient-reported outcome), validation

Outcome Measures

Primary Outcomes (1)

  • Examine the psychometric properties of the PsoTeenQOL

    Analyses will include exploratory factor analysis, examination of differential item functioning (DIF) and evaluation of indicators of reliability and validity of the instrument

    Baseline and up to 3 months after first completion of questionnaire package

Secondary Outcomes (2)

  • Indicators of validity

    Baseline

  • Indicators of reliability

    Test-retest: 2 weeks (+/-3 days) after baseline; Responsiveness: 3 months after baseline

Study Arms (3)

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

Parents of adolescents with psoriasis

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

Other: No intervention

Adolescents without psoriasis

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

Other: No intervention

Interventions

No interventionOTHER

Completion of surveys

Adolescents with psoriasisAdolescents without psoriasisParents of adolescents with psoriasis

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Inability to read Danish and complete electronic survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hilde Randa

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2017

First Posted

December 2, 2017

Study Start

February 20, 2018

Primary Completion

January 15, 2019

Study Completion

January 31, 2019

Last Updated

April 24, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)