A Multi-Site Randomized Controlled Trial of MS INFoRm: An Interactive Fatigue Management Resource for Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 3
- 主要终点
- Change in the Modified Fatigue Impact Scale
研究概览
简要总结
People with MS commonly experience extreme fatigue that negatively impacts their ability to engage in a full range of daily activities, quality of life, and employment. A new website called MS INFoRm (Multiple Sclerosis: An Interactive Fatigue Management Resource) allows people with MS to take a personalized and active approach to learning about and managing their fatigue. The aims of this study are:
- To determine to determine whether 3-month use of the MS INFoRm website can reduce the impact of fatigue on daily life among persons with MS.
- To determine whether 3-month use of the MS INFoRm website results in improvement in self- efficacy/ confidence for managing MS fatigue, self-reported cognitive function, participation and autonomy/ independence, and depression.
- To determine whether benefits are maintained among the MS INFoRm users after 6-months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both the MS INFoRm group and the control group will receive a login and password, although participants in the groups will be directed to a different webpages (i.e. a MS INFoRm page or usual care control webpage). This will facilitate blinding of participants to their allocation. The research assistant will complete the scheduling, data collection, and data entry blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •confirmed diagnosis of MS
- •between 18 and 65 years of age
- •access to a computer or other electronic device with internet access on which to use the website
- •report mild to moderate fatigue
- •live in Canada
排除标准
- •any major comorbid conditions that might influence fatigue management (lupus, rheumatoid arthritis, chronic obstructive lung disease, chronic fatigue syndrome)
- •report difficulty reading and comprehending English written at a Grade 7 level
- •report upper extremity or visual impairments that cannot be accommodated adequately to enable computer access
研究组 & 干预措施
MS INFoRm group
Participants in the MS INFoRm group will be given a login and password that will take them to the MS INFoRm webpage. Access will be granted for 3-months, starting on the date of the first login. Participants can access the website at any time, at their own volition over the 3-months.
干预措施: MS INFoRm (Behavioral)
Usual care control group
Participants in the usual care group will be given a login and password that will take them to a usual care webpage. Access will be granted for 3-months, starting on the date of the first login. Participants can access the website at any time, at their own volition over the 3-months.
干预措施: Usual Care Control Group (Behavioral)
结局指标
主要结局
Change in the Modified Fatigue Impact Scale
时间窗: Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).
21-item scale which assesses the impact of fatigue on daily functioning during the last four weeks.
次要结局
- Change in the Center for Epidemiological Studies Depression Scale(Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).)
- Change in the Multiple Sclerosis Self-Efficacy Scale(Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).)
- Change in the Impact on Participation and Autonomy Questionnaire(Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).)
- Change in the Perceived Deficits Questionnaire(Administered at baseline (week 1), 3-months (week 12), and 6-months (week 36).)
研究者
Dr. Marcia Finlayson
Vice Dean Health Sciences, Director School of Rehabilitation Therapy
Queen's University