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临床试验/NCT04100525
NCT04100525Unknown不适用

Neuropsychological Feedback Style and Case Management to Improve Intervention Outcome for Employed Women With Multiple Sclerosis: a Randomized Clinical Trial

Holy Name Medical Center, Inc.0 个研究点目标入组 89 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
89
主要终点
Employment

研究概览

简要总结

Unemployment is particularly common among women with multiple sclerosis (MS). This study uses a vocational rehabilitation program involving neuropsychological testing as an intervention. The use of in-person feedback and case management following neuropsychological testing is compared to phone feedback only. Adherence to treatment and employment outcomes will be evaluated over three years.

详细描述

Employed women at a tertiary-care MS center were screened for common issues impacting work productivity (fatigue, cognitive dysfunction, and depression). Women who met screening criteria were randomized to one of two treatment groups: either neuropsychological testing and phone feedback to review findings and tailored recommendations (standard-care treatment); or neuropsychological testing, in-person feedback, and two calls from a care-coordinator (experimental treatment). Adherence to recommendations and employment status at one year are evaluated. Follow-up periods also occur at year two and year three.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participants were informed that they would receive feedback but were not told whether it would be in person or by phone until after randomization. Participants were not informed that only one group received case management calls.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female sex
  • Age between 18 and 64
  • Employed at least 20 hours per week
  • Confirmed diagnosis of MS

排除标准

  • Experiencing an MS exacerbation
  • Endorsing suicidal ideation or intent
  • Severe psychiatric disorder
  • History of traumatic brain injury
  • Major neurological illness other than MS

结局指标

主要结局

Employment

时间窗: Approximately 12 months

Has there been a decrease in employment status (Yes/No)

次要结局

  • Adherence to Recommendations(Approximately 12 months)

研究者

申办方类型
Other
责任方
Sponsor

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