Web-Based Conversational Assistant After Total Knee Arthroplasty (CARE-TKA)
2026年7月23日 更新者：Wojciech Sroga
Evaluation of a Web-Based Conversational Postoperative Assistant on Patient Satisfaction and Exercise Adherence After Total Knee Arthroplasty: Protocol of a Pragmatic Randomized Pilot Study With 6-Week Follow-up
Total knee arthroplasty (TKA) is one of the most frequently performed elective orthopaedic procedures.
Following hospital discharge, patients must manage pain, wound care and home rehabilitation with limited professional support.
This pragmatic randomised pilot trial will evaluate whether a web-based conversational postoperative assistant, used in addition to standard care, improves patient satisfaction and exercise adherence during the first 6 weeks after TKA.
Forty to sixty patients undergoing primary elective TKA will be randomised 1:1 to standard care with or without access to the conversational assistant.
The primary outcome is overall patient satisfaction at 6 weeks.
Secondary outcomes include pain intensity, exercise adherence, unplanned healthcare contacts and postoperative complications.
研究概览
详细说明
This single-centre pragmatic randomized pilot trial will evaluate the feasibility and preliminary effectiveness of a web-based conversational postoperative assistant following primary total knee arthroplasty (TKA). Participants will be randomized in a 1:1 ratio to receive either standard postoperative care alone or standard care plus access to the conversational assistant for 6 weeks after surgery.
The assistant provides evidence-based postoperative education, recovery guidance, answers to common patient questions, and safety-oriented recommendations. The primary outcome is overall patient satisfaction at 6 weeks. Secondary outcomes include pain intensity, exercise adherence, unplanned healthcare contacts, and postoperative complications. The study is designed to generate preliminary evidence to support the development of a larger definitive randomized controlled trial.
研究类型
介入性
注册 (估计的)
60
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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Alicante
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Alcoy、Alicante、西班牙、03803
- Hospital Universitario Virgen de los Lirios
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接触：
- Wojciech Sroga, MD
- 电话号码：+34 648617730
- 邮箱：wstrauma@gmail.com
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接触：
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首席研究员：
- Wojciech Sroga, MD
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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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥18 years.
- Primary, unilateral, elective total knee arthroplasty (TKA).
- Discharged to home following surgery.
- Ability to use a smartphone or tablet with internet access (patient or caregiver).
- Written informed consent provided.
Exclusion Criteria:
- Revision or bilateral simultaneous TKA.
- Major postoperative complication precluding home discharge (e.g., admission to intensive care, unplanned return to theatre, or haemodynamic instability).
- Severe cognitive impairment precluding informed consent or device use.
- No access to an internet-enabled device.
- Inability or refusal to complete follow-up.
- Participation in another interventional study at enrolment.
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention
Participants receive standard postoperative care plus access to a web-based conversational postoperative assistant for 6 weeks after primary total knee arthroplasty.
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Participants assigned to the intervention group receive access to a web-based conversational assistant for 6 weeks after primary total knee arthroplasty.
The assistant provides evidence-based postoperative education, recovery guidance, answers to common patient questions, and safety-oriented recommendations.
It is available on demand and complements, but does not replace, standard postoperative care.
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无干预：Control
Participants receive standard postoperative care without access to the web-based conversational postoperative assistant.
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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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Overall Patient Satisfaction
大体时间：6 weeks after total knee arthroplasty
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Overall patient satisfaction measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates not satisfied at all and 10 indicates completely satisfied.
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6 weeks after total knee arthroplasty
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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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Pain Intensity
大体时间：2 weeks and 6 weeks after total knee arthroplasty
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Pain intensity measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
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2 weeks and 6 weeks after total knee arthroplasty
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Exercise Adherence
大体时间：During the first 6 weeks after total knee arthroplasty
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Exercise adherence assessed as the percentage of prescribed home exercise sessions completed, based on the participant's exercise diary.
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During the first 6 weeks after total knee arthroplasty
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Unplanned Healthcare Contacts
大体时间：During the first 6 weeks after total knee arthroplasty
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Number of unplanned healthcare contacts related to the operated knee, including primary care visits, emergency department visits, outpatient consultations, and hospital readmissions.
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During the first 6 weeks after total knee arthroplasty
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Postoperative Complications
大体时间：During the first 6 weeks after total knee arthroplasty
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Occurrence of postoperative complications related to the surgical procedure.
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During the first 6 weeks after total knee arthroplasty
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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。
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 (估计的)
2026年10月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年7月23日
首先提交符合 QC 标准的
2026年7月23日
首次发布 (实际的)
2026年7月28日
研究记录更新
最后更新发布 (实际的)
2026年7月28日
上次提交的符合 QC 标准的更新
2026年7月23日
最后验证
2026年7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.