A Telemedicine Solution for Remote Support of Rehabilitation, for Patients Undergoing, Total Hip Arthroplasty Surgery (RRS)
2012年10月22日 更新者:Martin Vesterby、Regionshospitalet Silkeborg
The Effect of Remote Rehabilitation Support Via a Telemedicine Solution for Patients Undergoing an Optimized Fast-track Orthopedic Surgery Procedure With the Implementation of a Total Hip Arthroplasty.
The RRS project is a Randomized Clinical Trial documenting the effect of Remote Rehabilitation and Support via a telemedicine solution for patients undergoing an optimized fast-track orthopedic surgery procedure with the implementation of a total hip arthroplasty.
With the telemedicine solution the investigators will support and try to motivate the patient to be discharged after only one day of hospitalization.
研究概览
详细说明
This PhD study evaluates the effect of an information technology solution containing RRS. The way it supports, informs and educates the patient and support person, provides an opportunity for communication between the patient and the surgeons, physiotherapists and nurses at the hospital.
The parameters evaluated will be: Length of stay, health-related quality-of-life (HRQOL), functional outcome, pain, anxiety, complications and an evaluation of the socio-economic effect.
The aim of the study generates the following hypotheses and focus for publication
- Length of stay is lower for the intervention group compared to the control group.
- The average quality of life measured with EQ-5D will either be the same or higher when comparing the intervention group with the control group.
- Compared to the control group the functional outcome of the intervention group measured with Oxford Hip Score (OHS) and Timed Up and Go (TUG) will be the same or better.
- Complications measured as luxations, infections, and reoperations are the same or lower in the intervention group compared to the control group.
- There will be a correlation between patients with the highest level of psychological problems and symptoms of psychopathology measured with Symptom Checklist-90-R, and the postoperative outcome measured with EQ5D, anxiety and TUG.
- There will be a correlation between support persons with the highest level of psychological problems and symptoms of psychopathology measured with Symptom Checklist-90-R, and the postoperative outcome measured with EQ5D, anxiety and TUG for the patient they are related to.
- The socio-economic costs will be lower for the intervention group compared to the control group based on self reported data and data collected from official databases. This study will be conducted as a piggy back to the RCT.
研究类型
介入性
注册 (实际的)
72
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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Silkeborg、丹麦、8600
- Regionshospitalet Silkeborg
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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
- 孩子
- 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:
- Patients qualified to go trough at joint-care procedure after the guidelines from Regionshospitalet Silkeborg.
Exclusion Criteria:
- Previous hip surgery with the implantation of a total hip arthroplasty.
- Patients living more than approximately 60 kilometers from the Regionshospitalet Silkeborg.
- Patients with no 3G tele-net at their home address.
- Patients with the need of Danish interpretation.
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:支持治疗
- 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:Telemedicine
RRS via telemedicine.
By developing the concept of Remote Rehabilitation Support (RRS) the investigators will try to bring preoperative education of the patient, dissemination of information and postoperative support to a new level.
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An information technology solution containing RRS.
The way it supports,, informs and educates the patient and support person, provides an opportunity for communication between the patient and the surgeons, physiotherapists and nurses at the hospital.
其他名称:
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无干预:Standard
The standard procedure for THA used under The Lundbeck Center for fast track hip and knee surgery
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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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EQ5D
大体时间:12个月
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12个月
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LOS
大体时间:up to 5 days
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Length of Stay
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up to 5 days
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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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SCL-90-r
大体时间:day 0
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psychological problems and symptoms of psychopathology
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day 0
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TUG
大体时间:day 90
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Time up and go
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day 90
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anxiety
大体时间:Day 90
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VAS - anxiety
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Day 90
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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
- 研究主任:Kjeld Soballe, Professor、University of Aarhus, Orthopaedic surgical research
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
2009年9月1日
初级完成 (实际的)
2012年3月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2009年8月28日
首先提交符合 QC 标准的
2009年8月28日
首次发布 (估计)
2009年8月31日
研究记录更新
最后更新发布 (估计)
2012年10月24日
上次提交的符合 QC 标准的更新
2012年10月22日
最后验证
2012年10月1日
更多信息
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