AsseSSing Impact in pSoriatic Treatment

Psoriatic Arthritis Clinical Trial

— ASSIST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05171270
• Other study ID #: 287039
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: University of Oxford
• Contact: Laura C Coates, MBChB
• Phone: 07870257823
• Email: laura.coates[@]ndorms.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Other:
• Questionnaire
PsAID questionnaire

Locations

Country	Name	City	State
France	CHU Gabriel-Montpied	Clermont-Ferrand
France	Centre Hospitalier Le Mans	Le Mans
France	Hopitaux Universitaires de Marseille	Marseille
France	GERPAL, Hopital de la Pitie	Paris
France	Centre Hospitalier Universitaire (CHU) de Toulouse	Toulouse
Germany	Klinikum Bamburg	Bamberg
Germany	Rheumatologische Schwerpunktpraxis	Berlin
Germany	Universitatsklinik Frankfurt	Frankfurt
Germany	Universitätsklinikum der Ruhr-Universität Bochum	Herne
Germany	MVZ für Rheumatologie Dr. Martin Welcker GmbH	Planegg
Italy	Ospedale Regionale Cardarelli	Campobasso
Spain	Hospital Clinic (Barcelona)	Barcelona
Spain	Complejo Universitario de a Coruña	Coruña
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario de Salamanca	Salamanca
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford	Yorkshire
United Kingdom	Cardiff and Vale University LHB	Cardiff	Wales
United Kingdom	Manchester University NHS Foundation Trust	Manchester	Greater Manchester
United Kingdom	Oxford University Hospital NHS Foundation Trust	Oxford	Oxfordshire
United Kingdom	Midlands Partnership NHS Foundation Trust	Stafford	Staffordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Amgen

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	CollaboRATE score	Patient satisfaction with consultation (scale 0-9 where higher score is better)	During the consultation (cross sectional study so only one timepoint)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)