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NCT02668341 Clinical Trial

Cross Sectional Analysis of Healthcare for Psoriasis in 4 European Countries

Psoriasis Clinical Trial

— PsoBarrier  

Official title:
PsoBarrierEU - Barrier Analysis of Guideline-Compliant Healthcare for Psoriasis in Europe

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02668341
Other study ID # IVDP-405-14
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 2015
Est. completion date December 2020

Study information
Verified date November 2020
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Analysis of barriers in psoriasis care from the patient's and the physician's perspective and generation of scientific data on the quality of health care in Denmark, Poland, Spain, and Germany

Description:

Cross-sectional, non-interventional study on healthcare for psoriasis in patients and their treating physicians. Clinical data on severity as well as subjective estimates on disease burden, quality of life etc. will be collected. Data collection is planned at multiple, representative sites in fourEuropean countries with different healthcare systems with the aim to identify system-dependent and -independent barriers in guideline-compliant psoriasis care.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1304
Est. completion date December 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - clinically diagnosed psoriasis vulgaris - age = 18 - written informed consent Exclusion Criteria: - lack of mental, physical or linguistic ability to participate in a questionnaire survey

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• non-interventional
non-interventional survey study

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus
Germany Nationwide group of dermatological centers, hospitals and medical offices Hamburg
Poland Medical University of Poznan Poznan
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (2)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf Sandoz

Countries where clinical trial is conducted

Denmark,  Germany,  Poland,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with severe disease receiving systemic treatment Baseline
Secondary Psoriasis Area and Severity Index (PASI) Psoriasis disease severity, measured by validated instrument Baseline
Secondary Body Surface Area (BSA) Psoriasis-affected body area, measured by physician estimate Baseline
Secondary Dermatology Life Quality Index (DLQI) Quality of life assessment in dermatologic patients, measured by validated quality of life instrument Baseline
Secondary EuroQuol (EQ-5D) generic quality of life assessment, measured by validated visual analogue scale Baseline
Secondary Percentage of patients with comorbidities receiving treatment. Baseline
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