AsseSSing Impact in pSoriatic Treatment (ASSIST)

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 503

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU Gabriel-Montpied
  • Le Mans, France
    • Centre Hospitalier Le Mans
  • Marseille, France
    • Hopitaux Universitaires de Marseille
  • Paris, France, 75651
    • GERPAL, Hopital de la Pitie
  • Toulouse, France
    • Centre Hospitalier Universitaire (CHU) de Toulouse
• Germany
  • Bamberg, Germany
    • Klinikum Bamburg
  • Berlin, Germany
    • Rheumatologische Schwerpunktpraxis
  • Frankfurt, Germany
    • Universitätsklinik Frankfurt
  • Herne, Germany
    • Universitätsklinikum der Ruhr-Universität Bochum
  • Planegg, Germany
    • MVZ für Rheumatologie Dr. Martin Welcker GmbH
• Italy
  • Campobasso, Italy
    • Ospedale Regionale Cardarelli
• Spain
  • Barcelona, Spain
    • Hospital Clinic (Barcelona)
  • Coruña, Spain
    • Complejo Universitario de a Coruña
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias
  • Salamanca, Spain
    • Hospital Universitario de Salamanca
• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9WL
      • Manchester University NHS Foundation Trust
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX39DU
      • Oxford University Hospital NHS Foundation Trust
  • Staffordshire
    • Stafford, Staffordshire, United Kingdom, ST16 3SR
      • Midlands Partnership NHS Foundation Trust
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4HH
      • Cardiff and vale University LHB
  • Yorkshire
    • Bradford, Yorkshire, United Kingdom, BD9 6RJ
      • Bradford Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with a diagnosis of PsA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Psoriatic arthritis; Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation.	Other: Questionnaire; PsAID questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Undergoing Treatment Escalation	Treatment escalation definition includes increase in dose, frequency, change of route, new medication	During the consultation visit (around 30-60 mins)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Undergoing Reduction of Therapy	Treatment reduction definition includes decrease in dose, frequency, change in route, stopping medication	During the consultation visit (around 30-60 mins)
Mean PsAID-12 Scores	PsA impact of disease score (scale 0-10 where higher score is worse)	During the consultation visit (around 30-60 mins)
Median CollaboRATE Score	Patient satisfaction with consultation (scale 0-9 where higher score is better)	During the consultation visit (around 30-60 mins)
Median Perceived Efficacy on Patient-physician Interaction Score (PEPPI)	A patient-reported questionnaire to assess their perceived efficacy in a healthcare consultation. This consists of 5 questions which the patient rates on a likert scale of 1 to 5. The score for each of the questions are summed together giving a score range of 5-25 where higher score is better)	During the consultation visit (around 30-60 mins)
Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision	Likert scale 1-5 where; A lot more likely to decrease or not change therapy; Somewhat more likely to decrease or not change therapy; No impact on treatment decision; Somewhat more likely to increase therapy; A lot more likely to increase therapy A higher score means that the PsAID 12 was more likely to influence treatment decisions.	During the consultation visit (around 30-60 mins)

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Amgen

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): March 22, 2022
• Study Completion (Actual): March 22, 2022

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Treatment decisions; Impact of disease
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Arthritis; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: 287039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Available on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No