AsseSSing Impact in pSoriatic Treatment

Study Overview
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Brief Summary
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Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice. This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA. This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.

Detailed Description
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This is an observational, cross-sectional study addressing the factors influencing treatment decisions in patients with PsA. Participants will be treated as usual in their routine clinical practice, but decisions on treatment will be recorded - whether treatment is escalated, unchanged or reduced, and why. The study will be conducted in 25 rheumatology centres in Europe (UK, France, Germany, Spain and Italy) with five centres in each country. Each participant will only attend for one single study visit which is likely to last around 30 minutes in total. This will be alongside the participant's routine clinic visit. The PsAID-12 questionnaire will be implemented on a tablet computer but the remaining outcomes will be collected on paper CRFs and transferred to a database for analysis.

Official Title
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How Does PsAID Implementation Affect Treatment Intensification and Patient Satisfaction in PsA

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study and complete questionnaires in the local language. Aged 18 years or above. Diagnosed with PsA according to the ClASification of Psoriatic ARthritis (CASPAR) criteria and diagnosis confirmed by a rheumatologist (Taylor 2006). Exclusion Criteria: Patients who don't speak or read the local language Patients who are not comfortable filling in an app-based questionnaire or paper CRF. Patients with a new diagnosis of PsA at the current clinic visit

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 |
| --- | --- |
| Psoriatic arthritis<br>Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. | Other: Questionnaire<br>* PsAID questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients undergoing treatment escalation | Treatment escalation definition includes increase in dose, frequency, change of route, new medication | During the consultation (cross sectional study so only one timepoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of therapy | Treatment reduction definition includes decrease in dose, frequency, change in route, stopping medication | During the consultation (cross sectional study so only one timepoint) | 
| PsAID-12 scores | PsA impact of disease score (scale 0-10 where higher score is worse) | During the consultation (cross sectional study so only one timepoint) | 
| CollaboRATE score | Patient satisfaction with consultation (scale 0-9 where higher score is better) | During the consultation (cross sectional study so only one timepoint) | 
| Perceived efficacy on Patient-physician interaction score (PEPPI) | Perceived efficacy in consultation (scale 5-25 where higher score is better) | During the consultation (cross sectional study so only one timepoint) | 
| Physicians opinion of how much arthritis is driving treatment decision | Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse) | During the consultation (cross sectional study so only one timepoint) | 
| Physicians opinion of how PsAID 12 influenced treatment decision | Likert scale 1-5 (scale 0-5 where higher score is worse) | During the consultation (cross sectional study so only one timepoint) | 
| Physicians opinion of how much enthesitis is driving treatment decision | Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse) | During the consultation (cross sectional study so only one timepoint) | 
| Physicians opinion of how much psoriasis is driving treatment decision | Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse) | During the consultation (cross sectional study so only one timepoint) | 
| Physicians opinion of how much systemic inflammation marker (CRP) is driving treatment decision | Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse) | During the consultation (cross sectional study so only one timepoint) | 
| Physicians opinion of how much PROs are driving treatment decision | Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse) | During the consultation (cross sectional study so only one timepoint) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment decisions, Impact of disease