Cross Sectional Analysis of Healthcare for Psoriasis in 4 European Countries

• Conditions: Psoriasis
• Interventions: Other: non-interventional

• Registration Number: NCT02668341
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-01-29
• Primary Completion: 2020-09
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1304

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
psoriasis patients in Denmark	non-interventional	non-interventional survey study in psoriasis patients in daily practice care
psoriasis patients in Poland	non-interventional	non-interventional survey study in psoriasis patients in daily practice care
psoriasis patients in Germany	non-interventional	non-interventional survey study in psoriasis patients in daily practice care
psoriasis patients in Spain	non-interventional	non-interventional survey study in psoriasis patients in daily practice care

Primary Outcome Measures

Name	Time	Method
Percentage of patients with severe disease receiving systemic treatment	Baseline

Secondary Outcome Measures

Name	Time	Method
Body Surface Area (BSA)	Baseline	Psoriasis-affected body area, measured by physician estimate
Dermatology Life Quality Index (DLQI)	Baseline	Quality of life assessment in dermatologic patients, measured by validated quality of life instrument
Percentage of patients with comorbidities receiving treatment.	Baseline
Psoriasis Area and Severity Index (PASI)	Baseline	Psoriasis disease severity, measured by validated instrument
EuroQuol (EQ-5D)	Baseline	generic quality of life assessment, measured by validated visual analogue scale

Trial Locations

Locations (4)

Nationwide group of dermatological centers, hospitals and medical offices; 🇩🇪 Hamburg, Germany

Medical University of Poznan; 🇵🇱 Poznan, Poland

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain