The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A RCT
2020年8月23日 更新者:Robert Elson PT、Aultman Health Foundation
The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A Randomized Clinical Trial
The purpose of this study is to determine the impact a mobile health application has on adherence to a physical therapy home exercise program and its effect on functional outcomes.
研究概览
详细说明
Outpatient physical therapy is an integral aspect in combating the impairment and dysfunction associated with musculoskeletal injuries.
Healthcare and insurance restrictions are leading to reduced clinic visits, encouraging efficient and effective treatments and focusing a greater demand on education, proactive wellness and home exercise maintenance.
Home exercise prescription has long been a fundamental aspect to a physical therapy routine or regimen.
It is well established that exercise protocols can positively impact pain, fitness levels, physical function and measures of life quality (Forkan, Pumper, Smyth, Wirkkala, A Ciol, & Shumway-Cook, 2006).
It is also recognized that treatment outcomes may be negatively impacted by non-adherence to the prescribed exercise recommendation in rehabilitation (Holden, Haywood, Portia, Gee, & Mclean, 2014).
Research historically suggests that levels of non-adherence to exercise prescription range from 50-70% (Bassett, 2003; Sluijs, Kok, & van der Zee, 1993), and likely increase as time passes.
Investigating non-adherence demonstrates a myriad of influencing factors.
These factors can be characterized as motivators and barriers.
With the explosion of mobile communications access and increasing number of active device users, healthcare is embarking on the concept of mobile health management.
Mobile health interventions have been found to have a positive impact in the arenas of medication compliance, weight loss, chronic disease management and postoperative complication (Lee, 2016; Ronghua, Li, (2015).The implementation of a mobile health application in physical therapy outpatient management has not been well established.
It is time to investigate the impact of using a mobile health application on a prescribed physical therapy treatment regimen for the enhancement of HEP adherence and functional outcome assessment.
研究类型
介入性
注册 (实际的)
104
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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Ohio
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Canton、Ohio、美国、44710
- Aultman Hospital - West Physical Therapy
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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 至 100年 (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:
- Any musculoskeletal pathology: spine, UE, LE
- Age18 or older
- Primary language is English. Ability to read, write and understand the English language
- Ownership of mobile smart phone
- Functional and cognitive ability to operate/manipulate a mobile media application
- Willingness to use their data package for support/use of mobile application
Exclusion Criteria:
Following the initial screening criteria, the study population will be scrutinized for exclusion.
Exclusion criteria:
- History of neurological pathology with neurological impairments
- Impaired cognition
- Difficulty with operation and manipulation of mobile application
- Difficulty with directions as set forth by the intake The exclusion criteria will be screened by written intake and a traditional medical history by the primary researcher. Subject enrollment will commence after eligibility is met and informed consent received.
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Traditional Group
The control group will receive traditional PT services as deemed clinically appropriate via examination to include traditional home exercise prescription.
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The Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription.
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实验性的:Augmented Media Group
The Augmented Media group will receive traditional PT services as deemed clinically appropriate via examination and include home exercise prescription via a mobile health application.
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The intervention group will receive traditional PT services deemed clinically appropriate via examination plus home exercise prescription augmented via a mobile health application.
The augmented media group will receive digital exercise prescription via a mobile health application source (Physitrack) that includes: high definition video and pictures, education material and written instruction, reminder notification and in-app logging of completion.
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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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Adherence Exercise Logs: Adherence = exercise reps completed (x) sets completed (x) times per day completed (x) days per week completed divided by total number of (reps) (sets) (time per day) (days per week) assigned to the HEP regimen for each patient
大体时间:Weekly during course of patient standard treatment. Logs will be assessed over each 7 day period after initial treatment session and collected up to a period of 24 weeks or discharge from therapy intervention for any reason, which ever may occur first.
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Weekly during course of patient standard treatment. Logs will be assessed over each 7 day period after initial treatment session and collected up to a period of 24 weeks or discharge from therapy intervention for any reason, which ever may occur first.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Self -report Adherence Question: Both groups will complete a single question assessment regarding their perceived level of adherence to the prescribed home exercise plan.
大体时间:Completed at 1 week after inital exam , at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and 3 month follow-up. 6month follow-up if subject agreeable.
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Completed at 1 week after inital exam , at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and 3 month follow-up. 6month follow-up if subject agreeable.
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Numeric Pain Rating Scale (NPRS) 0-10 scale.
大体时间:Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first.
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Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first.
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Patient-Specific Functional Scale (PSFS)
大体时间:Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first.
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Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first.
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The Global Rating of Change Scale (GROC)
大体时间:At patient discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and at 3 month follow-up. 6month follow-up if subject agreeable.
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At patient discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and at 3 month follow-up. 6month follow-up if subject agreeable.
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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:Robert A Elson, MPT、Aultman Health Foundation
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1月23日
初级完成 (实际的)
2018年7月23日
研究完成 (实际的)
2019年12月12日
研究注册日期
首次提交
2017年1月18日
首先提交符合 QC 标准的
2017年1月26日
首次发布 (估计)
2017年1月30日
研究记录更新
最后更新发布 (实际的)
2020年8月25日
上次提交的符合 QC 标准的更新
2020年8月23日
最后验证
2020年8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
- 2016.11RE
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.
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