此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty

The Effects of a Patient-specific Integrated Education Program on Pain, Perioperative Anxiety, and Functional Recovery Following Total Knee Replacement

This project is about the integrated rehabilitation program for the patients receiving total knee arthroplasty. The investigators are monitoring the WOMAC(Western Ontario and Mcmaster University Arthritis Index)/ Pain scores/Anxiety scores/Knee society scores in the treatment course between the intervention group and the control group.

研究概览

详细说明

This is a quasi-experimental design study. The participants received total knee arthroplasty by one single surgeon in two facilities within the same medical system (Kaohsiung Medical University affiliated hospitals). The intervention groups received integrated rehabilitation program including verbal one-on-one education, personalized post-operation rehabilitation during admission and scheduled post-operation follow up by a nurse case manager. The control group received the same surgery with traditional clinical pathway by the single surgeon in another affiliated hospital.

We recorded the pain scores, state-trait anxiety inventory scores, WOMAC(Western Ontario and Mcmaster Universities Arthritis Index) scores, American Knee society scores for these participants.

研究类型

介入性

注册 (实际的)

70

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

      • Kaohsiung、台湾
        • Kaohsiung Medical University Hospital

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

是的

有资格学习的性别

全部

描述

Inclusion Criteria

  • Patients over 65 years of age
  • Patients scheduled to receive unilateral total knee arthroplasty due to advanced osteoarthritis
  • Patients are able to understand the study and express opinions clearly
  • Patients are willing to participate in this study and provide informed consents

Exclusion Criteria

  • Patients with inflammatory joint disease
  • Patients with neurosensory system disease (such as stroke or parkinsonism)
  • Patients have intellectual impairment, or dementia.

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:非随机化
  • 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
实验性的:integrated rehabilitation program for total knee arthroplasty
the intervention was performed in one KMUH affiliated facility
Pre-operative education and rehabilitation. During hospitalization: group rehabilitation education program. Discharge: post-operative care navigation for total knee arthroplasty
无干预:normal total knee arthroplasty clinical pathway
no integrated rehabilitatoin program for total knee arthroplasty patients with our conventional clinical pathway

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
Visual Analogue Pain Score (VAS)
大体时间:From admission to 3 months after surgery
Minimum pain intensity from 0 to Maximum of 10. Higher scores mean a higher pain intensity.
From admission to 3 months after surgery
State-trait Anxiety Inventory (STAI)
大体时间:From admission to 3 months after surgery
Peri-operative anxiety scoring system. STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). Higher scores mean higher anxiety.
From admission to 3 months after surgery
American Knee Society Scores(AKS)
大体时间:From admission to 3 months after surgery
The AKS ranges from 100 (normal knee function score) to 0 (worst knee function score). Higher scores mean a better outcome.
From admission to 3 months after surgery
WOMAC (Western Ontario and Mcmaster Universities Arthritis Index)
大体时间:From admission to 3 months after surgery
The WOMAC evaluates 3 dimensions : pain(maximal score of 20), stiffness(maximal score of 8), and physical function(maximal score of 68). Higher scores mean worse outcomes.
From admission to 3 months after surgery

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。

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)

2019年9月17日

初级完成 (实际的)

2021年7月31日

研究完成 (实际的)

2021年7月31日

研究注册日期

首次提交

2022年4月14日

首先提交符合 QC 标准的

2022年4月20日

首次发布 (实际的)

2022年4月26日

研究记录更新

最后更新发布 (实际的)

2022年4月26日

上次提交的符合 QC 标准的更新

2022年4月20日

最后验证

2022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

  • KMUHIRB-E(I)-20190255

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

No sharing of the individual participant data

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

膝关节炎的临床试验

3
订阅