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临床试验/NCT05171270
NCT05171270Unknown不适用

How Does PsAID Implementation Affect Treatment Intensification and Patient Satisfaction in PsA

University of Oxford21 个研究点 分布在 5 个国家目标入组 500 人开始时间: 2021年7月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
21
主要终点
Number of Patients Undergoing Treatment Escalation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

结局指标

主要结局

Number of Patients Undergoing Treatment Escalation

时间窗: During the consultation visit (around 30-60 mins)

Treatment escalation definition includes increase in dose, frequency, change of route, new medication

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (21)

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