Enhanced Medical Rehabilitation in Older Adults (EMR)
2020年6月23日 更新者：Eric Lenze、Washington University School of Medicine
The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an effective treatment for older adults after disabling medical events.
研究概览
地位
完全的
详细说明
The intervention involves physical and occupational therapy for patients who have been admitted to a skilled nursing facility for therapy following a disabling medical event.
Participants in this study will be randomly assigned to receive either Enhanced or standard of care therapy, meaning they will either receive their PT (Physical Therapy)& OT(Occupational Therapy) from therapists who have been specially trained in the study intervention or from therapists with normal training. Participants will be assessed at baseline, 30, 60, and 90 days after baseline, and at the date of their discharge from the skilled nursing facility.
研究类型
介入性
注册 (实际的)
229
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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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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Saint Louis、Missouri、美国、63105
- Barnes-Jewish Extended Care
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Saint Louis、Missouri、美国、63125
- Alexian Brothers Sherbrooke Village
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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
65年 及以上 (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:
- 65 and older
- Admitted to a skilled nursing facility for post-acute care from PT and OT for 2 weeks or more.
Exclusion Criteria:
- Language, visual or hearing barriers to participation
- Medical illness preventing study participation or accurate data collection
- Moderate-severe dementia (demonstrated by chart diagnosis and/or short blessed score greater than 13)
- Progressive neurological condition such that recovery of function is not feasible
- Patient did not have the ability to walk prior to hospitalization (e.g. paraplegic)
- Schizophrenia or other chronic or current psychotic disorder.
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 |
|---|---|
|
有源比较器：Standard of Care Rehabilitation
|
Daily PT/OT provided by therapists not trained in the treatment intervention.
|
|
实验性的：Enhanced Medical Rehabilitation
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Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation.
This training focuses on improved communication, patient engagement, and intensity.
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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 |
|---|---|---|
|
Change in Barthel Index Score
大体时间：Baseline and Discharge, an average of 24 days.
|
Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.
|
Baseline and Discharge, an average of 24 days.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gait Speed (Determined by 4 or 10 Meter Walk Test)
大体时间：Discharge, an average of 24 days after baseline.
|
Meters walked per second.
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Discharge, an average of 24 days after baseline.
|
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Distance Ambulated in 6-Minute Walk Test
大体时间：Discharge, an average of 24 days after baseline.
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Feet walked during 6 minute interval.
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Discharge, an average of 24 days after baseline.
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Self-reported Barthel Index
大体时间：30, 60, and 90 Days Post Admission to the SNF
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Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.
Conducted as a self-report at timepoints where patient was not in an institutional setting.
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30, 60, and 90 Days Post Admission to the SNF
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Discharge Disposition
大体时间：Discharge, an average of 24 days after baseline.
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Number of participants discharged from skilled nursing facility to home
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Discharge, an average of 24 days after baseline.
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Rehospitalizations
大体时间：Days 30, 60, and 90 post admission to a SNF as well as at Discharge
|
Assesses whether the participant was readmitted to the hospital.
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Days 30, 60, and 90 post admission to a SNF as well as at Discharge
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bland MD, Birkenmeier RL, Barco P, Lenard E, Lang CE, Lenze EJ. Enhanced Medical Rehabilitation: Effectiveness of a clinical training model. NeuroRehabilitation. 2016 Oct 14;39(4):481-498. doi: 10.3233/NRE-161380.
- Ercal B, Rodebaugh TL, Bland MD, Barco P, Lenard E, Lang CE, Miller JP, Yingling M, Lenze EJ. Executive Function Moderates Functional Outcomes of Engagement Strategies During Rehabilitation in Older Adults. Am J Phys Med Rehabil. 2021 Jul 1;100(7):635-642. doi: 10.1097/PHM.0000000000001739.
- Lenze EJ, Lenard E, Bland M, Barco P, Miller JP, Yingling M, Lang CE, Morrow-Howell N, Baum CM, Binder EF, Rodebaugh TL. Effect of Enhanced Medical Rehabilitation on Functional Recovery in Older Adults Receiving Skilled Nursing Care After Acute Rehabilitation: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jul 3;2(7):e198199. doi: 10.1001/jamanetworkopen.2019.8199.
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)
2014年7月29日
初级完成 (实际的)
2018年7月13日
研究完成 (实际的)
2018年7月13日
研究注册日期
首次提交
2014年4月2日
首先提交符合 QC 标准的
2014年4月10日
首次发布 (估计)
2014年4月15日
研究记录更新
最后更新发布 (实际的)
2020年7月7日
上次提交的符合 QC 标准的更新
2020年6月23日
最后验证
2020年6月1日
更多信息
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.