PsoriasisPsoBarrierNCT02668341
Cross Sectional Analysis of Healthcare for Psoriasis in 4 European Countries
An observational study of Psoriasis, run by Universitätsklinikum Hamburg-Eppendorf at 4 sites in 4 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- non-interventional
- How many people
- 1,304 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Oct 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with diagnosed psoriasis vulgaris
Who may be able to join
- clinically diagnosed psoriasis vulgaris
- age ≥ 18
- written informed consent
Who cannot join
- lack of mental, physical or linguistic ability to participate in a questionnaire survey
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Germany1 site
Nationwide group of dermatological centers, hospitals and medical offices
Hamburg
About this study
Official title: 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
Read the 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.
- Conditions
- Psoriasis
- Being tested
- non-interventional
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionalOther
Also called non-interventional survey study
non-interventional survey study
| Study group | Role | What they receive |
|---|---|---|
| psoriasis patients in Denmark | non-interventional survey study in psoriasis patients in daily practice care Receives: Other: non-interventional | |
| psoriasis patients in Spain | non-interventional survey study in psoriasis patients in daily practice care Receives: Other: non-interventional | |
| psoriasis patients in Poland | non-interventional survey study in psoriasis patients in daily practice care Receives: Other: non-interventional | |
| psoriasis patients in Germany | non-interventional survey study in psoriasis patients in daily practice care Receives: Other: non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with severe disease receiving systemic treatment
Measured: Baseline
Secondary outcomes (5)
Psoriasis Area and Severity Index (PASI)
Psoriasis disease severity, measured by validated instrument
Measured: Baseline
Body Surface Area (BSA)
Psoriasis-affected body area, measured by physician estimate
Measured: Baseline
Dermatology Life Quality Index (DLQI)
Quality of life assessment in dermatologic patients, measured by validated quality of life instrument
Measured: Baseline
EuroQuol (EQ-5D)
generic quality of life assessment, measured by validated visual analogue scale
Measured: Baseline
Percentage of patients with comorbidities receiving treatment.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2020
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Sandoz
- Responsible party
- Sponsor
- Investigators
- Matthias Augustin, Prof. Dr., Study director, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668341
- Sponsor's protocol ID
- IVDP-405-14
- Acronym
- PsoBarrier
- Status last verified
- Nov 2020
- First submitted
- 12 Oct 2015
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PsoBarrierEU - Barrier Analysis of Guideline-Compliant Healthcare for Psoriasis in Europe
- ClinicalTrials.gov ID
- NCT02668341
- Acronym / sponsor ID
- PsoBarrier / IVDP-405-14
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,304 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Sandoz
- Study start
- Oct 2015
- Primary completion
- Sep 2020 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| psoriasis patients in Denmark | – | Other: non-interventionalnon-interventional survey study in psoriasis patients in daily practice care |
| psoriasis patients in Spain | – | Other: non-interventionalnon-interventional survey study in psoriasis patients in daily practice care |
| psoriasis patients in Poland | – | Other: non-interventionalnon-interventional survey study in psoriasis patients in daily practice care |
| psoriasis patients in Germany | – | Other: non-interventionalnon-interventional survey study in psoriasis patients in daily practice care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with diagnosed psoriasis vulgaris
Key inclusion criteria (3 listed)
- clinically diagnosed psoriasis vulgaris
- age ≥ 18
- written informed consent
Key exclusion criteria (1 listed)
- lack of mental, physical or linguistic ability to participate in a questionnaire survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-interventionalAlso: non-interventional survey studynon-interventional survey study | Other | psoriasis patients in Denmark, psoriasis patients in Germany, psoriasis patients in Poland, psoriasis patients in Spain |
Primary outcome
Percentage of patients with severe disease receiving systemic treatment
Time frame: Baseline
5 secondary outcomes
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline
Body Surface Area (BSA)
Time frame: Baseline
Dermatology Life Quality Index (DLQI)
Time frame: Baseline
EuroQuol (EQ-5D)
Time frame: Baseline
Percentage of patients with comorbidities receiving treatment.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Augustin, Prof. Dr. study director
Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Universitätsklinikum Hamburg-Eppendorf at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Germany, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with severe disease receiving systemic treatment (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.