TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS) (TakeCharge)
Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties
The proposed project will evaluate the efficacy of a telephone-delivered self-management (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is hypothesized that if the effects of these conditions are reduced, study participants will demonstrate improved participation in the community and improved employment outcomes. This project is important because the majority of persons with MS experience one or more of the following secondary conditions: fatigue, pain, depression, and cognitive impairment. These secondary conditions are not always readily apparent and constitute what has been described by our Rehabilitation Research and Training Center as "hidden disabilities." Secondary conditions such as pain, depression, fatigue, and cognitive impairment frequently not only cause distress in their own right but also affect employment, participation, and quality of life. Having more than one often compounds the effect; the effect of all may be greater than the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment can worsen depression).
It is critical that this constellation of secondary symptoms be addressed using state of the art techniques based on self-management training and that intervention effects be documented with carefully controlled treatment efficacy studies.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Washington
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Seattle、Washington、美国、98195
- University of Washington
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Must be diagnosed with MS by a physician.
- Must be at least 18 years of age.
- Must be able to understand, speak, and read English.
- Must have the presence of at least one of four common secondary conditions (fatigue, pain, depression, cognitive difficulties) that interferes with employment, participation, and functioning.
Exclusion Criteria:
- Unable to understand or read English.
- Severe cognitive impairment, defined as one or more errors on the 6-item screener, that would prevent informed consent and inability to carry on a phone conversation.
- Currently participating in regularly scheduled psychotherapy.
- Psychiatric contraindications such as current psychosis, active suicidal ideation, or current alcohol or drug use.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Self-management Intervention
Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.
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Brief counseling technique, self-management,
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有源比较器：Education
Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
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Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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PHQ 9
大体时间：Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Brief Pain Inventory
大体时间：Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Modified Fatigue Impact Scale
大体时间：Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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PROMIS Depression Short Form
大体时间：Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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PROMIS Pain Impact Short Form
大体时间：Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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PROMIS Fatigue Short Form
大体时间：Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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合作者和调查者
调查人员
- 首席研究员：Dawn Ehde, PhD、University of Washington
- 研究主任：George Kraft, MD、University of Washington
出版物和有用的链接
一般刊物
- Knowles LM, Arewasikporn A, Kratz AL, Turner AP, Alschuler KN, Ehde DM. Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis. Ann Behav Med. 2021 Aug 23;55(9):833-843. doi: 10.1093/abm/kaaa102.
- Ehde DM, Arewasikporn A, Alschuler KN, Hughes AJ, Turner AP. Moderators of Treatment Outcomes After Telehealth Self-Management and Education in Adults With Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1265-1272. doi: 10.1016/j.apmr.2017.12.012. Epub 2018 Jan 11.
- Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith AE, Amtmann D. Efficacy of a Telephone-Delivered Self-Management Intervention for Persons With Multiple Sclerosis: A Randomized Controlled Trial With a One-Year Follow-Up. Arch Phys Med Rehabil. 2015 Nov;96(11):1945-58.e2. doi: 10.1016/j.apmr.2015.07.015. Epub 2015 Aug 6.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 36021-C
- H133B080025 (其他赠款/资助编号：NIDRR)
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Self-management intervention的临床试验
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National... 和其他合作者完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人