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临床试验/NCT03375541
NCT03375541撤回不适用

Benefits of Drug Risk Aversion Calculation to Multiple Sclerosis Drug Choice and Patient Self-efficacy

Duke University0 个研究点开始时间: 2018年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Change from Baseline Disease Self-efficacy

研究概览

简要总结

The investigators seek to determine if the use of a Side Effect Aversion Calculator helps patients with multiple sclerosis (MS) more comfortably and rapidly identify the disease modifying drug (DMD) that is best suited for the patient.

详细描述

Settling into the use of a multiple sclerosis disease modifying drug (DMD) can seem like taking an important final examination, consisting of a single multiple choice question with 16 equally appropriate responses, having months or even years to second-guess your choice, and then getting a grade but never being told the correct answer.

Making the choice between these options can be overwhelming, leaving patients feeling both disempowered and depersonalized in the decision-making process.

In order to allow a better, more personalized, decision-making process the investigators introduce a side effect aversion calculator, which takes a patient's individual side effect aversion profile into consideration when discussing the start of a new disease modifier (initial drug, or drug switch). Subjects will be multiple sclerosis patients who have a provider-identified need for DMD initiation or DMD switch and receive their care at Duke. Recruitment goal is 100 subjects. Those randomized to "calculator arms" will be reminded that the purpose of the calculator is to facilitate the DMD choice discussion, NOT make the decision. Subjects asked to rate level of concern over adverse events (AEs) across all DMDs. Calculator multiplies subject response by the prevalence reported within DMD prescribing information. Sum of these weighted scores reveals a DMD's Total Aversion score and medication ranking by patient's specific side effect aversion profile, therefore framing discussion. Enrollment visit concludes with survey designed to collect MS clinical history, MS symptoms, medication history, medication adherence and self-efficacy. This same survey is conducted prior to subsequent three clinic visits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Be at least 18 years old
  • Be able to read and speak English
  • Be currently treated or starting treatment with an MS disease modifying medication

排除标准

  • All of the inclusion criteria must be met. If they cannot be met, then they are excluded from the study

研究组 & 干预措施

Calculator

Experimental

Natural discussion of disease modifier selection conducted with augmentation by risk aversion calculator

干预措施: Risk Aversion Calculator (Other)

Control

No Intervention

Natural discussion of disease modifier selection conducted without augmentation by risk aversion calculator

结局指标

主要结局

Change from Baseline Disease Self-efficacy

时间窗: Baseline and then at the conclusion of the initial 1 day visit

Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis

次要结局

  • Change from Baseline Disease Self-efficacy at 12 months(At enrollment and at 12 months post-visit)
  • Time to new medication start(6 months)
  • Medication adherence(At enrollment and at each subsequent visit for one year)
  • Change from Baseline Disease Self-efficacy at 6 months(At enrollment and at 6 months post-visit)

研究者

申办方类型
Other
责任方
Sponsor

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