The Study of Koebner in Patients With Psoriasis and Psoriatic Arthritis

Study Overview
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Brief Summary
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PSODEEP 1 is a descriptive digital interview study where we intend to include at least 900 individuals. Individuals with known psoriasis or known psoriatic arthritis will access the digital interview via a QR code distributed via their rheumatology or dermatology department using their smartphones. Data on answers results are stored digitally and can be accessed parallel to recruitment. Questions focus on following fields (all self reported): background information (age/sex), disease duration, disease course/fluctuation, disease diagnosis as given by MD, disease treatment, disease severity, disease classification, disease triggers, screening of psoriatic arthritis (questions derived from PEST questionnaire), Koebner occurence, variability in Koebner over time, deep-Koebner occurence and variability in Deep-Koebner over time.

Detailed Description
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PSODEEP1 is a descriptive digital interview study. Questions on self reported experience of following fields will be stated: background information, disease duration, disease course/fluctuation, disease diagnosis as given by MD, disease treatment, disease severity, disease classification, disease triggers, screening of psoriatic arthritis (questions derived from PEST questionnaire), Koebner occurence, variability in Koebner over time, deep-Koebner occurence and variability in Deep-Koebner over time. Questions will be distributed using REDCap (REsearch Electronic Data CAPture) platform provided by Lunds university, University of Santiago and Copenhagen University (www.project-redcap.org). Patients with known psoriasis or psoriatic arthritis will reach the questionnaire using a QR-code on patient's information sheet distributed in clinical settings. In Sweden, patients will be recruited at dermatology and rheumatology outpatient clinics in Malmö, Lund, Göteborg, Örebro, Stockholm (Skåne University Hospital, Karolinska Hospital, Sahlgrenska Hospital, Ryhov Hospital, Örebro, Hospital). In Chile patients will be recruited at Hospital Clínico Universidad de Chile and CIEC-PMR Centro Internacional de Estudios Clínicos - Probity Medical Research. In Denmark, patients will be recruited at Gentofte Hospital and through Leo foundation skin immunology research center (Copenhagen University) and the Parker Institute. Study inclusion criteria: Physician diagnosed psoriasis, psoriatic arthritis or both. Age of 18 years or older. Ability to comprehend instructions and read the Swedish, Spanish or Danish language (according to country). Having a smartphone with which one can access the study questions using a QR code. Study exclusion criteria: Having participated in the study already. Not having a mobile telephone number (used to identify duplicate answers).

Official Title
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Questionnaire on Self-reported Experience of Koebner and Deep-Koebner Phenomenon in Patients With Psoriasis and Psoriatic Arthritis.

Conditions
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Psoriasis, Psoriasis; Arthritis (Etiology), Koebner Phenomenon

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MD diagnosis of psoriasis and/or psoriasis arthritis Age over 18 years Ability to read and understand written questions Having/ability to use smartphone Given consent Exclusion Criteria: - Having participated previously

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PSODEEP1 Sweden<br>Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Sweden. | |
| PSODEEP1 Denmark<br>Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Denmark. | |
| PSODEEP1 Chile<br>Patients with self reported MD given diagnosis of psoriasis and/or psoriatic arthritis in Chile. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Koebner | Occurence of Self-Reported Koebner phenomena. Self-reported in multiple choice questionnaire Has your skin psoriasis ever developed at the site of a skin injury, such as a scrape or a burn? YES/NO/DO NOT KNOW. Ordinal data. | Through study completion, estimated to 12 months. | 
| Trauma induced Deep-Koebner | Occurence of Self-Reported trauma induced Deep-Koebner phenomena in patients with with psoriasis arthritis. Questionnaire, self-reported, multiple choice Have you ever developed psoriatic arthritis in a joint after injury, e.g. after a fall or sprain?  YES/NO/DO NOT KNOW. Ordinal data. | Through study completion, estimated to 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in Koebner | Variation of self-reported Koebner over time. In patients with self-reported Koebner a following multiple choice question will assess if Koebner is a constant phenomenon or whether it is associated with periods of high psoriasis disease activity. Multiple choice answers, self-reported, collected in questionnaire. Ordinal data. | Through study completion, estimated to 12 months. | 
| Variation in Trauma induced Deep-Koebner | Variation of self-reported Trauma induced Deep-Koebner over time. In patients with self-reported trauma induced Deep-Koebner a following multiple choice question will assess if Deep-Koebner is a constant phenomenon or whether it is associated with periods of high psoriasis disease activity. Answer is multiple choice, self-reported. Ordinal data. | Through study completion, estimated to 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Koebner, Deep-Koebner, Psoriasis, Arthritis