AsseSSing Impact in pSoriatic Treatment
- Conditions
- Psoriatic Arthritis
- Interventions
- Other: Questionnaire
- Registration Number
- NCT05171270
- Lead Sponsor
- University of Oxford
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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).
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Psoriatic arthritis Questionnaire Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation.
- Primary Outcome Measures
Name Time Method Number of Patients Undergoing Treatment Escalation During the consultation visit (around 30-60 mins) Treatment escalation definition includes increase in dose, frequency, change of route, new medication
- Secondary Outcome Measures
Name Time Method Number of Patients Undergoing Reduction of Therapy During the consultation visit (around 30-60 mins) Treatment reduction definition includes decrease in dose, frequency, change in route, stopping medication
Mean PsAID-12 Scores During the consultation visit (around 30-60 mins) PsA impact of disease score (scale 0-10 where higher score is worse)
Median CollaboRATE Score During the consultation visit (around 30-60 mins) Patient satisfaction with consultation (scale 0-9 where higher score is better)
Median Perceived Efficacy on Patient-physician Interaction Score (PEPPI) During the consultation visit (around 30-60 mins) 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)
Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision During the consultation visit (around 30-60 mins) Likert scale 1-5 where
1. A lot more likely to decrease or not change therapy
2. Somewhat more likely to decrease or not change therapy
3. No impact on treatment decision
4. Somewhat more likely to increase therapy
5. A lot more likely to increase therapy A higher score means that the PsAID 12 was more likely to influence treatment decisions.
Trial Locations
- Locations (21)
Complejo Universitario de a Coruña
🇪🇸Coruña, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Universitatsklinik Frankfurt
🇩🇪Frankfurt, Germany
Universitätsklinikum der Ruhr-Universität Bochum
🇩🇪Herne, Germany
MVZ für Rheumatologie Dr. Martin Welcker GmbH
🇩🇪Planegg, Germany
Ospedale Regionale Cardarelli
🇮🇹Campobasso, Italy
Hospital Clinic (Barcelona)
🇪🇸Barcelona, Spain
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, France
Klinikum Bamburg
🇩🇪Bamberg, Germany
Rheumatologische Schwerpunktpraxis
🇩🇪Berlin, Germany
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
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, United Kingdom
Cardiff and Vale University LHB
🇬🇧Cardiff, Wales, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
🇬🇧Bradford, Yorkshire, United Kingdom