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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriatic arthritis | Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | PsAID questionnaire |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with a diagnosis of PsA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Gabriel-Montpied | Clermont-Ferrand | 63000 | France | |||
| Centre Hospitalier Le Mans |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38011669 | Derived | 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. |
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Available on reasonable request
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Recruitment in rheumatology outpatient clinics at sites between 12/07/2021 and 22/03/2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Psoriatic Arthritis | Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full population
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| ID | Title | Description |
|---|---|---|
| BG000 | Psoriatic Arthritis | Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Undergoing Treatment Escalation | Treatment escalation definition includes increase in dose, frequency, change of route, new medication | Full population | Posted | Count of Participants | Participants | During the consultation visit (around 30-60 mins) |
|
|
Single visit (1 hour)
Standard definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psoriatic Arthritis | Psoriatic arthritis Impact of Disease questionnaires (PsAID) used within routine clinic consultation. Questionnaire: PsAID questionnaire |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Laura Coates | University of Oxford | 07870257823 | laura.coates@ndorms.ox.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2020 | Nov 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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
| During the consultation visit (around 30-60 mins) |
| Le Mans |
| France |
| Hopitaux Universitaires de Marseille | Marseille | France |
| GERPAL, Hopital de la Pitie | Paris | 75651 | France |
| Centre Hospitalier Universitaire (CHU) de Toulouse | Toulouse | France |
| 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 | Germany |
| Ospedale Regionale Cardarelli | Campobasso | Italy |
| Complejo Universitario de a Coruña | A Coruña | Spain |
| Hospital Clinic (Barcelona) | Barcelona | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Spain |
| Hospital Universitario de Salamanca | Salamanca | Spain |
| Manchester University NHS Foundation Trust | Manchester | Greater Manchester | M13 9WL | United Kingdom |
| Oxford University Hospital NHS Foundation Trust | Oxford | Oxfordshire | OX39DU | United Kingdom |
| Midlands Partnership NHS Foundation Trust | Stafford | Staffordshire | ST16 3SR | United Kingdom |
| Cardiff and Vale University LHB | Cardiff | Wales | CF14 4HH | United Kingdom |
| Bradford Teaching Hospitals NHS Foundation Trust | Bradford | Yorkshire | BD9 6RJ | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Patients Undergoing Reduction of Therapy | Treatment reduction definition includes decrease in dose, frequency, change in route, stopping medication | Full population | Posted | Count of Participants | Participants | During the consultation visit (around 30-60 mins) |
|
|
|
| Secondary | Mean PsAID-12 Scores | PsA impact of disease score (scale 0-10 where higher score is worse) | Full population | Posted | Mean | Standard Deviation | score on a scale | During the consultation visit (around 30-60 mins) |
|
|
|
| Secondary | Median CollaboRATE Score | Patient satisfaction with consultation (scale 0-9 where higher score is better) | Full population | Posted | Median | Full Range | score on a scale | During the consultation visit (around 30-60 mins) |
|
|
|
| Secondary | 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) | Full population | Posted | Median | Full Range | score on a scale | During the consultation visit (around 30-60 mins) |
|
|
|
| Secondary | Median Score for Physicians Opinion of How PsAID 12 Influenced Treatment Decision | Likert scale 1-5 where
| Complete data | Posted | Median | Full Range | score on a scale | During the consultation visit (around 30-60 mins) |
|
|
|
| 0 |
| 503 |
| 0 |
| 503 |
| 0 |
| 503 |
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| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |