Evaluation of a Web-Based Fall Prevention Program on People With Multiple Sclerosis
2018年4月5日 更新者：Michelle Cameron、Oregon Health and Science University
This study evaluates the effectiveness of a web-based fall prevention program called Free From Falls Online (FFFO) on people with multiple sclerosis.
研究概览
详细说明
The overarching goal of this study is to evaluate the effectiveness and impact of an online self-management program for preventing falls among people with multiple sclerosis (PwMS).
To accomplish this objective, the investigators have designed a web-based fall prevention program called Free From Falls Online (FFFO), based on the traditionally in-person program developed by the National Multiple Sclerosis Society.
The specific aims of this study are three-fold: (1) to evaluate the effectiveness of an online fall prevention self-education program by comparing fall frequency between participants and controls; (2) evaluate the impact of FFFO by comparing patient reported measures of physical function, fatigue, self-efficacy, psychosocial illness impact, social participation and satisfaction, and perception of global health between participants and controls; (3) and to determine usability of and satisfaction with FFFO.
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health Sciences University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- MS of any type with no relapse in the previous month
- Self-reported history of 2 or more falls in the previous 2 months
- Ability to walk at least 100 meters with intermittent or unilateral constant assistance (Expanded Disability Severity Scale (EDSS) step <6.0)
- Daily access a computer and willingness to respond to a daily survey
Exclusion Criteria:
- Medical conditions that would preclude reliable participation or increases risk for injury during the program
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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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有源比较器：Free From Falls
Subjects in the active group will participate in the Free From Falls Online Program consisting of 8 weekly 30 minute webinars providing education about risk factors for falls and fall prevention strategies; self-assessment exercises to evaluate understanding of the material; video-based exercise program targeting balance, posture, strength and flexibility to be performed at least 3 times per week; supplementary, downloadable printed material for both education and exercise; and a social forum to allow participants to interact with each other.
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Subjects in the active group will participate in the Free From Falls Online Program consisting of 8 weekly 30 minute webinars providing education about risk factors for falls and fall prevention strategies; self-assessment exercises to evaluate understanding of the material; video-based exercise program targeting balance, posture, strength and flexibility to be performed at least 3 times per week; supplementary, downloadable printed material for both education and exercise; and a social forum to allow participants to interact with each other.
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安慰剂比较：Waitlist
Subjects in the waitlist control condition will receive an educational brochure developed by the National Multiple Sclerosis Society called "Minimizing Your Risk of Falls: A Guide for People with MS," which includes information on identifying risk factors for falling and fall risk management approaches with no exercise component; will inform their provider that they have fallen at least twice in the previous 2 months and discuss subsequent falls over the course of the 5-month study; and will be invited to participate in the Free From Falls Online Program at study completion.
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Subjects in the waitlist control condition will receive an educational brochure developed by the National Multiple Sclerosis Society called "Minimizing Your Risk of Falls: A Guide for People with MS," which includes information on identifying risk factors for falling and fall risk management approaches with no exercise component; will inform their provider that they have fallen at least twice in the previous 2 months and discuss subsequent falls over the course of the 5-month study; and will be invited to participate in the Free From Falls Online Program at study completion.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference in mean change in total falls between intervention and control arms
大体时间：5 months
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To determine if participation in FFFO is associated with decreased frequency of falls, subjects will be randomly assigned to either the active intervention group or the waitlist control group.
All subjects will prospectively document the number and circumstances of their falls for 5 months through the use of an electronic survey, to include the 8 weeks of the active or control intervention and 3-month follow-up.
The primary outcome will be the difference in fall frequency between active and control subjects.
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5 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference in patient reported outcomes including physical function, fatigue, self efficacy, psychosocial illness impact, social participation and satisfaction, and perception of global health between intervention and control arms.
大体时间：5 months
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To determine if participation in FFFO is associated with improvement in patient reported outcomes, subjects will be randomly assigned to either the active intervention group or the waitlist control group.
Outcomes will be measured through the use of the Patient Reported Outcomes Measurement Information System (PROMIS) which has been validated in people with multiple sclerosis.
All subjects will complete the questionnaires at baseline, at 8 weeks and at 3 month follow-up.
Scores will be compared between active and control subjects.
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5 months
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Quantitative assessment of the web-based program
大体时间：8 weeks
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To determine usability and satisfaction with FFFO, subjects in the active group will complete a computer-based questionnaire at the end of the program.
The investigators will quantitatively evaluate participant assessment of the FFFO program through the use of a 5-point Likert scale.
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8 weeks
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Qualitative assessment of the web-based program
大体时间：8 weeks
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To determine usability and satisfaction with FFFO, subjects in the active group will complete a computer-based questionnaire at the end of the program.
The investigators will qualitatively evaluate participant assessment of the FFFO program through the use of free-text responses.
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8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michelle H Cameron, MD、Portland VA Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年2月15日
初级完成 (实际的)
2018年1月25日
研究完成 (实际的)
2018年1月25日
研究注册日期
首次提交
2016年8月22日
首先提交符合 QC 标准的
2016年8月25日
首次发布 (估计)
2016年8月31日
研究记录更新
最后更新发布 (实际的)
2018年4月9日
上次提交的符合 QC 标准的更新
2018年4月5日
最后验证
2018年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 00015595
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Free From Falls Online的临床试验
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Portland VA Medical CenterOregon Health and Science University完全的