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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Laura C Coates, MBChB
- 电话号码：07870257823
- 邮箱：laura.coates@ndorms.ox.ac.uk
研究联系人备份
- 姓名：Jaia Barratt
- 电话号码：02031922074
- 邮箱：assist@springer.com
学习地点
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Bamberg、德国
- 招聘中
- Klinikum Bamburg
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接触：
- Axel Hueber
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Berlin、德国
- 招聘中
- Rheumatologische Schwerpunktpraxis
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接触：
- Jan Brandt-Jurgens
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Frankfurt、德国
- 招聘中
- Universitätsklinik Frankfurt
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接触：
- Michaela Kohm
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Herne、德国
- 招聘中
- Universitätsklinikum der Ruhr-Universität Bochum
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接触：
- Uta Kiltz
- 邮箱：uta.kiltz@elisabethgruppe.de
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Planegg、德国
- 招聘中
- MVZ für Rheumatologie Dr. Martin Welcker GmbH
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接触：
- Martin Welcker
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Campobasso、意大利
- 招聘中
- Ospedale Regionale Cardarelli
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接触：
- Ennio Lubrano
- 邮箱：enniolubrano@hotmail.com
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Clermont-Ferrand、法国、63000
- 招聘中
- CHU Gabriel-Montpied
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接触：
- Martin Soubrier
- 邮箱：msoubrier@chu-clermontferrand.fr
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Le Mans、法国
- 招聘中
- Centre Hospitalier Le Mans
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接触：
- Emmanuelle Dernis
- 邮箱：edernis@ch-lemans.fr
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Marseille、法国
- 招聘中
- Hôpitaux Universitaires de Marseille
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接触：
- Sandrine Guis
- 邮箱：sandrine.guis@ap-hm.fr
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Paris、法国、75651
- 招聘中
- GERPAL, Hopital de la Pitie
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接触：
- Laure Gossec
- 邮箱：laura.gossec@aphp.fr
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Toulouse、法国
- 招聘中
- Centre hospitalier universitaire (CHU) de Toulouse
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接触：
- Adeline Ruyssen-Witrand
- 邮箱：ruyssen-witrand.a@chu-toulouse.fr
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Greater Manchester
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Manchester、Greater Manchester、英国、M13 9WL
- 招聘中
- Manchester University NHS Foundation Trust
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接触：
- Pauline Ho
- 邮箱：pauline.ho@mft.nhs.uk
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Oxfordshire
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Oxford、Oxfordshire、英国、OX39DU
- 招聘中
- Oxford University Hospital NHS Foundation Trust
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接触：
- Laura C Coates, MBChB
- 电话号码：07870257823
- 邮箱：laura.coates@ndorms.ox.ac.uk
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Staffordshire
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Stafford、Staffordshire、英国、ST16 3SR
- 尚未招聘
- Midlands Partnership NHS Foundation Trust
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接触：
- Jon Packham
- 邮箱：jon.packham@mpft.nhs.uk
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Wales
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Cardiff、Wales、英国、CF14 4HH
- 招聘中
- Cardiff and Vale University LHB
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接触：
- Ernest Choy
- 邮箱：choyEH@cardiff.ac.uk
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Yorkshire
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Bradford、Yorkshire、英国、BD9 6RJ
- 招聘中
- Bradford Teaching Hospitals NHS Foundation Trust
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接触：
- Sarah Twigg
- 邮箱：sarah.twigg@bthft.nhs.uk
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Barcelona、西班牙
- 尚未招聘
- Hospital Clinic (Barcelona)
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接触：
- Julio Ramiez Garcia
- 邮箱：julramga@gmail.com
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Coruña、西班牙
- 尚未招聘
- Complejo Universitario de a Coruña
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接触：
- Jose Antonio Pinto
- 邮箱：jose.antonio.pinto.tasende@sergas.es
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Madrid、西班牙
- 尚未招聘
- Hospital Universitario 12 de Octubre
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接触：
- Beatriz Joven Ibanez
- 邮箱：beatrizjoven@hotmail.com
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Oviedo、西班牙
- 尚未招聘
- Hospital Universitario Central de Asturias
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接触：
- Ruben Queiro
- 邮箱：rubenque7@yahoo.es
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Salamanca、西班牙
- 招聘中
- Hospital Universitario de Salamanca
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接触：
- Carlos Montilla Morales
- 邮箱：montillamorales.carlos@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of patients undergoing treatment escalation
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Reduction of therapy
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：During the consultation (cross sectional study so only one timepoint)
|
Visual Analogue Scale 0-10 (scale 0-10 where higher score is worse)
|
During the consultation (cross sectional study so only one timepoint)
|
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Physicians opinion of how much PROs are driving treatment decision
大体时间：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)
|
合作者和调查者
合作者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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