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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Laura C Coates, MBChB
- Numero di telefono: 07870257823
- Email: laura.coates@ndorms.ox.ac.uk
Backup dei contatti dello studio
- Nome: Jaia Barratt
- Numero di telefono: 02031922074
- Email: assist@springer.com
Luoghi di studio
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Clermont-Ferrand, Francia, 63000
- Reclutamento
- CHU Gabriel-Montpied
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Contatto:
- Martin Soubrier
- Email: msoubrier@chu-clermontferrand.fr
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Le Mans, Francia
- Reclutamento
- Centre Hospitalier Le Mans
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Contatto:
- Emmanuelle Dernis
- Email: edernis@ch-lemans.fr
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Marseille, Francia
- Reclutamento
- Hôpitaux Universitaires de Marseille
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Contatto:
- Sandrine Guis
- Email: sandrine.guis@ap-hm.fr
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Paris, Francia, 75651
- Reclutamento
- GERPAL, Hopital de la Pitie
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Contatto:
- Laure Gossec
- Email: laura.gossec@aphp.fr
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Toulouse, Francia
- Reclutamento
- Centre hospitalier universitaire (CHU) de Toulouse
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Contatto:
- Adeline Ruyssen-Witrand
- Email: ruyssen-witrand.a@chu-toulouse.fr
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Bamberg, Germania
- Reclutamento
- Klinikum Bamburg
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Contatto:
- Axel Hueber
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Berlin, Germania
- Reclutamento
- Rheumatologische Schwerpunktpraxis
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Contatto:
- Jan Brandt-Jurgens
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Frankfurt, Germania
- Reclutamento
- Universitätsklinik Frankfurt
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Contatto:
- Michaela Kohm
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Herne, Germania
- Reclutamento
- Universitätsklinikum der Ruhr-Universität Bochum
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Contatto:
- Uta Kiltz
- Email: uta.kiltz@elisabethgruppe.de
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Planegg, Germania
- Reclutamento
- MVZ für Rheumatologie Dr. Martin Welcker GmbH
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Contatto:
- Martin Welcker
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Campobasso, Italia
- Reclutamento
- Ospedale Regionale Cardarelli
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Contatto:
- Ennio Lubrano
- Email: enniolubrano@hotmail.com
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Greater Manchester
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Manchester, Greater Manchester, Regno Unito, M13 9WL
- Reclutamento
- Manchester University NHS Foundation Trust
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Contatto:
- Pauline Ho
- Email: pauline.ho@mft.nhs.uk
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Oxfordshire
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Oxford, Oxfordshire, Regno Unito, OX39DU
- Reclutamento
- Oxford University Hospital NHS Foundation Trust
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Contatto:
- Laura C Coates, MBChB
- Numero di telefono: 07870257823
- Email: laura.coates@ndorms.ox.ac.uk
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Staffordshire
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Stafford, Staffordshire, Regno Unito, ST16 3SR
- Non ancora reclutamento
- Midlands Partnership NHS Foundation Trust
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Contatto:
- Jon Packham
- Email: jon.packham@mpft.nhs.uk
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Wales
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Cardiff, Wales, Regno Unito, CF14 4HH
- Reclutamento
- Cardiff and vale University LHB
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Contatto:
- Ernest Choy
- Email: choyEH@cardiff.ac.uk
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Yorkshire
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Bradford, Yorkshire, Regno Unito, BD9 6RJ
- Reclutamento
- Bradford Teaching Hospitals NHS Foundation Trust
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Contatto:
- Sarah Twigg
- Email: sarah.twigg@bthft.nhs.uk
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Barcelona, Spagna
- Non ancora reclutamento
- Hospital Clinic (Barcelona)
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Contatto:
- Julio Ramiez Garcia
- Email: julramga@gmail.com
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Coruña, Spagna
- Non ancora reclutamento
- Complejo Universitario de a Coruña
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Contatto:
- Jose Antonio Pinto
- Email: jose.antonio.pinto.tasende@sergas.es
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Madrid, Spagna
- Non ancora reclutamento
- Hospital Universitario 12 de Octubre
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Contatto:
- Beatriz Joven Ibanez
- Email: beatrizjoven@hotmail.com
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Oviedo, Spagna
- Non ancora reclutamento
- Hospital Universitario Central de Asturias
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Contatto:
- Ruben Queiro
- Email: rubenque7@yahoo.es
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Salamanca, Spagna
- Reclutamento
- Hospital Universitario de Salamanca
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Contatto:
- Carlos Montilla Morales
- Email: montillamorales.carlos@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Psoriatic arthritis
Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation.
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PsAID questionnaire
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of patients undergoing treatment escalation
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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Treatment escalation definition includes increase in dose, frequency, change of route, new medication
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During the consultation (cross sectional study so only one timepoint)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Reduction of therapy
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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Treatment reduction definition includes decrease in dose, frequency, change in route, stopping medication
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During the consultation (cross sectional study so only one timepoint)
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PsAID-12 scores
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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PsA impact of disease score (scale 0-10 where higher score is worse)
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During the consultation (cross sectional study so only one timepoint)
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CollaboRATE score
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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Patient satisfaction with consultation (scale 0-9 where higher score is better)
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During the consultation (cross sectional study so only one timepoint)
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Perceived efficacy on Patient-physician interaction score (PEPPI)
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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Perceived efficacy in consultation (scale 5-25 where higher score is better)
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During the consultation (cross sectional study so only one timepoint)
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Physicians opinion of how much arthritis is driving treatment decision
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
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During the consultation (cross sectional study so only one timepoint)
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Physicians opinion of how PsAID 12 influenced treatment decision
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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Likert scale 1-5 (scale 0-5 where higher score is worse)
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During the consultation (cross sectional study so only one timepoint)
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Physicians opinion of how much enthesitis is driving treatment decision
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
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During the consultation (cross sectional study so only one timepoint)
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Physicians opinion of how much psoriasis is driving treatment decision
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
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During the consultation (cross sectional study so only one timepoint)
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Physicians opinion of how much systemic inflammation marker (CRP) is driving treatment decision
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
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During the consultation (cross sectional study so only one timepoint)
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Physicians opinion of how much PROs are driving treatment decision
Lasso di tempo: During the consultation (cross sectional study so only one timepoint)
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Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
|
During the consultation (cross sectional study so only one timepoint)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 287039
Piano per i dati dei singoli partecipanti (IPD)
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