Clinical trial NCT05171270: AsseSSing Impact in pSoriatic Treatment
Official title: How Does PsAID Implementation Affect Treatment Intensification and Patient Satisfaction in PsA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Keywords: Treatment decisions
Impact of disease
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2021-12-28
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with a diagnosis of PsA

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Undergoing Treatment Escalation
timeFrame: During the consultation visit (around 30-60 mins)
Secondary outcomes:
measure: Number of Patients Undergoing Reduction of Therapy
timeFrame: During the consultation visit (around 30-60 mins)
measure: Mean PsAID-12 Scores
timeFrame: During the consultation visit (around 30-60 mins)
measure: Median CollaboRATE Score
timeFrame: During the consultation visit (around 30-60 mins)
measure: Median Perceived Efficacy on Patient-physician Interaction Score (PEPPI)
timeFrame: During the consultation visit (around 30-60 mins)
measure: Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision
timeFrame: During the consultation visit (around 30-60 mins)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Gabriel-Montpied
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Marseille
country: France
facility: Hopitaux Universitaires de Marseille
city: Paris
country: France
facility: GERPAL, Hopital de la Pitie
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire (CHU) de Toulouse
city: Bamberg
country: Germany
facility: Klinikum Bamburg
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis
city: Frankfurt
country: Germany
facility: Universitatsklinik Frankfurt
city: Herne
country: Germany
facility: Universitätsklinikum der Ruhr-Universität Bochum
city: Planegg
country: Germany
facility: MVZ für Rheumatologie Dr. Martin Welcker GmbH
city: Campobasso
country: Italy
facility: Ospedale Regionale Cardarelli
city: Barcelona
country: Spain
facility: Hospital Clinic (Barcelona)
city: Coruña
country: Spain
facility: Complejo Universitario de a Coruña
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: Greater Manchester
city: Oxford
country: United Kingdom
facility: Oxford University Hospital NHS Foundation Trust
state: Oxfordshire
city: Stafford
country: United Kingdom
facility: Midlands Partnership NHS Foundation Trust
state: Staffordshire
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University LHB
state: Wales
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
state: Yorkshire
Study officials:
References: