AsseSSing Impact in pSoriatic Treatment

NCT05171270 | Completed Results

• 1 other identifier: 287039
• Study Type: observational
• Target: 503
• Locations: 5 countries
• Sites: 21

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.

Conditions

Psoriatic Arthritis

Keywords

Treatment decisions; Impact of disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Patients Undergoing Reduction of Therapy

  During the consultation visit (around 30-60 mins)

• Mean PsAID-12 Scores

  During the consultation visit (around 30-60 mins)

• Median CollaboRATE Score

  During the consultation visit (around 30-60 mins)

• Median Perceived Efficacy on Patient-physician Interaction Score (PEPPI)

  During the consultation visit (around 30-60 mins)

• Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision

  During the consultation visit (around 30-60 mins)

Study Arms (1)

Psoriatic arthritis

Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation.

Other: Questionnaire

Interventions

Questionnaire OTHER

PsAID questionnaire

Psoriatic arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with a diagnosis of PsA

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Amgen: collaborator

Study Sites (21)

CHU Gabriel-Montpied

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier Le Mans

Le Mans, France

Location

Hopitaux Universitaires de Marseille

Marseille, France

Location

GERPAL, Hopital de la Pitie

Paris, 75651, France

Location

Centre Hospitalier Universitaire (CHU) de Toulouse

Toulouse, France

Location

Klinikum Bamburg

Bamberg, Germany

Location

Rheumatologische Schwerpunktpraxis

Berlin, Germany

Location

Universitatsklinik Frankfurt

Frankfurt, Germany

Location

Universitätsklinikum der Ruhr-Universität Bochum

Herne, Germany

Location

MVZ für Rheumatologie Dr. Martin Welcker GmbH

Planegg, Germany

Location

Ospedale Regionale Cardarelli

Campobasso, Italy

Location

Complejo Universitario de a Coruña

A Coruña, Spain

Location

Hospital Clinic (Barcelona)

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Oxford University Hospital NHS Foundation Trust

Oxford, Oxfordshire, OX39DU, United Kingdom

Location

Midlands Partnership NHS Foundation Trust

Stafford, Staffordshire, ST16 3SR, United Kingdom

Location

Cardiff and Vale University LHB

Cardiff, Wales, CF14 4HH, United Kingdom

Location

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, Yorkshire, BD9 6RJ, United Kingdom

Location

Related Publications (1)

• Watson L, Coyle C, Whately-Smith C, Brooke M, Kiltz U, Lubrano E, Queiro R, Trigos D, Brandt-Juergens J, Choy E, D'Angelo S, Delle Sedie A, Dernis E, Guis S, Helliwell P, Ho P, Hueber AJ, Joven B, Koehm M, Montilla C, Packham J, Pinto Tasende JA, Ramirez Garcia FJ, Ruyssen-Witrand A, Scrivo R, Twigg S, Soubrier M, Wirth T, Gossec L, Coates LC. An international multicentre analysis of current prescribing practices and shared decision-making in psoriatic arthritis. Rheumatology (Oxford). 2024 Dec 1;63(12):3449-3456. doi: 10.1093/rheumatology/kead621.

  PMID: 38011669 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Professor Laura Coates
• Organization: University of Oxford

laura.coates@ndorms.ox.ac.uk

07870257823

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 28, 2021
• Study Start: July 12, 2021
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2023-12

Locations

GB (5); ES (5); IT (1); FR (5); DE (5)