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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Patient Satisfaction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study. Participants and investigators are aware of the assigned intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Overall Patient Satisfaction
时间窗: 6 weeks after total knee arthroplasty
Overall patient satisfaction measured using an 11-point Numeric Rating Scale (NRS), where 0 indicates not satisfied at all and 10 indicates completely satisfied.
次要结局
- Unplanned Healthcare Contacts(During the first 6 weeks after total knee arthroplasty)
- Pain Intensity(2 weeks and 6 weeks after total knee arthroplasty)
- Exercise Adherence(During the first 6 weeks after total knee arthroplasty)
- Postoperative Complications(During the first 6 weeks after total knee arthroplasty)
研究者
Wojciech Sroga
Principal Investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana