Cross Sectional Analysis of Healthcare for Psoriasis in 4 European Countries (PsoBarrier)

November 3, 2020 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
  • Germany
      • Hamburg, Germany
        • Nationwide group of dermatological centers, hospitals and medical offices
  • Poland
      • Poznan, Poland, 60-355
        • Medical University of Poznan
  • Spain
      • Barcelona, Spain, 08026
        • Hospital De La Santa Creu I Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult patients with diagnosed psoriasis vulgaris

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
psoriasis patients in Denmark
non-interventional survey study in psoriasis patients in daily practice care
Other: non-interventional
non-interventional survey study
Other Names:
  • non-interventional survey study
psoriasis patients in Spain
non-interventional survey study in psoriasis patients in daily practice care
Other: non-interventional
non-interventional survey study
Other Names:
  • non-interventional survey study
psoriasis patients in Poland
non-interventional survey study in psoriasis patients in daily practice care
Other: non-interventional
non-interventional survey study
Other Names:
  • non-interventional survey study
psoriasis patients in Germany
non-interventional survey study in psoriasis patients in daily practice care
Other: non-interventional
non-interventional survey study
Other Names:
  • non-interventional survey study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with severe disease receiving systemic treatment
Time Frame: Baseline
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Sandoz

Investigators

  • Study Director: Matthias Augustin, Prof. Dr., Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

September 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVDP-405-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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