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临床试验/NCT03317756
NCT03317756已完成不适用

CONfident Treatment Decisions in Living With Rheumatoid Arthritis

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2018年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
208
试验地点
2
主要终点
Patient willingness to adopt T2T and the attainment of the T2T goals.

研究概览

简要总结

Pilot test the novel educational patient-directed intervention to demonstrate the feasibility of the novel educational approaches developed in improving patient's willingness to achieve remission or low disease activity in RA.

详细描述

Pilot test the novel educational patient-directed intervention to demonstrate the feasibility of the novel educational approaches developed in improving patient's willingness to achieve remission or low disease activity in RA. Upon agreement to participate, the patient participants will provide information on their treating physician. This information will be used to invite physicians to complete the physician-educational intervention and offered CME credits for completing the activity.

The investigators will recruit participants from a patient registry (1:1 intervention: control) that meet the eligibility criteria. The recruited patients will complete the educational intervention (if randomized to the intervention arm) and the study outcomes will be collected immediately after the intervention and also after the patients most proximate rheumatologist visit (up to 6-months later).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

intervention and control arms

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

  • Have a patient-reported diagnosis of RA
  • Most recent RAPID3 > 12 collected in the last 6 months
  • Have not changed RA medication in the last 6 months
  • Taking medications that are commonly used in RA (e.g. methotrexate, sulfasalazine, hydroxychloroquine (plaquenil), leflunomide (arava), etanercept (enbrel), adalimumab (Humira), tofacitinib (xeljanz), actemra (tocilizumab), sarilumab (Kevzara) , infliximab (remicade), golimumab (Simponi), rituximab (rituxan), abatacept (Orencia), and certolizumab (Cimzia))

排除标准

  • Does not meet inclusion criteria
  • Age < 18

结局指标

主要结局

Patient willingness to adopt T2T and the attainment of the T2T goals.

时间窗: Follow-up Survey #1 (after completion of the intervention)

Name of Scale: Choice predisposition scale The scale measures the willingness to change medication. The scale is a 11-point likert type scale that is scored from not willing at all (minimum) to extremely willing (maximum) with an unsure option (neutral). Higher scores (closer to the maximum) indicate a willingness to change medication and desire to further improve their RA disease activity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Danila, MD, MSc, MSPH

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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