Neuropsychological Feedback Style and Case Management to Improve Intervention Outcome for Employed Women With Multiple Sclerosis: a Randomized Clinical Trial
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
- 是
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
研究组 & 干预措施
Standard Care
Participant received neuropsychological testing, report detailing cognitive strengths and weaknesses, tailored recommendations to address areas of weakness (including psychological and/or physical symptoms impacting work productivity). Participant received a copy of this report in the mail and a call from the psychologist to go over test findings and recommendations.
干预措施: Neuropsychological testing intervention plus follow up (Behavioral)
Experimental Treatment
Participant received neuropsychological testing, report detailing cognitive strengths and weaknesses, tailored recommendations to address areas of weakness (including psychological and/or physical symptoms impacting work productivity). Participant then receives in-person feedback (and a copy of the report at this visit) and two calls from a care-coordinator research nurse at approximately 1 and 6 months post feedback, who asks participant whether they completed recommendations and assist participant in completing recommendations where possible (i.e., help find a provider, explanation of importance of completing recommendations, etc).
干预措施: Neuropsychological testing intervention plus follow up (Behavioral)
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)