A Randomized Controlled Trial of Nurse-Led Telehealth Versus In-Person Consultations in Detecting Complications and Improving Recovery After Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Number of Participants with Postoperative Complications Detected Within Four Weeks Following Total Knee Replacement
研究概览
简要总结
Brief Summary
The goal of this clinical trial is to learn if nurse-led telehealth consultations can help detect complications and support recovery after total knee replacement surgery. The study will compare telehealth nursing consultations to traditional in-person nursing visits.
The main questions it aims to answer are:
- Can nurse-led telehealth detect post-surgery complications as well as or better than in-person consultations?
- Does telehealth nursing support better or equivalent recovery outcomes and patient satisfaction compared to in-person care?
Participants will:
- Be adults who had their first total knee replacement surgery.
- Receive follow-up care either through telehealth consultations using the HA Go mobile app or through traditional face-to-face nurse visits in the outpatient clinic.
- Attend scheduled consultations and provide information about their recovery and any complications they experience.
- Complete surveys about their satisfaction with the care they receive.
This study will help determine if telehealth nursing consultations can provide safe, effective, and convenient follow-up care for patients after knee replacement surgery, potentially improving access and reducing travel burdens.
详细描述
Detailed Description This study is a randomized controlled trial designed to evaluate the clinical effectiveness and feasibility of nurse-led telehealth consultations compared to traditional in-person nursing consultations for post-operative care following total knee replacement (TKR) surgery.
Background and Rationale Total knee replacement is a common surgical intervention for end-stage knee osteoarthritis, offering significant pain relief and improved function. Post-operative follow-up is essential to monitor recovery, detect complications early, and support rehabilitation. However, traditional in-person consultations can pose logistical challenges for patients, including mobility limitations, travel burden, and time constraints. Telehealth has emerged as a promising alternative by enabling remote clinical assessments and patient monitoring, especially amplified by recent advances and adoption during the COVID-19 pandemic.
While telehealth models led by physicians have been studied extensively, there is a relative lack of evidence regarding nurse-led telehealth consultations in the orthopedic post-operative setting. Nurses play a crucial role in patient education, symptom monitoring, and care coordination, making nurse-led telehealth a potentially efficient and scalable solution. This study aims to fill this gap by rigorously evaluating whether nurse-led telehealth consultations can detect complications and support recovery as effectively as standard in-person visits.
Study Design
This is an open-label, parallel-group randomized controlled trial with two arms:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults aged 18 years or older
- •Undergoing their first total knee replacement surgery
- •Within 4 weeks after surgery
- •Medically stable for discharge and suitable for home-based follow-up care
- •Have access to a smartphone and internet (for telehealth participants)
- •Able to communicate effectively in Cantonese
- •Provide informed consent to participate in the study
排除标准
- •Undergoing bilateral or revision total knee replacement surgery
- •Require immediate or intensive medical attention post-surgery (e.g., severe infection, hospitalization over 7 days)
- •Have severe systemic disease (ASA physical status classification III or higher)
- •Lack the technical ability or resources to participate in telehealth consultations
- •Unable to communicate effectively in Cantonese
- •Undergoing surgeries other than first-time total knee replacement
结局指标
主要结局
Number of Participants with Postoperative Complications Detected Within Four Weeks Following Total Knee Replacement
时间窗: Within 4 weeks (28 days) post-surgery
This outcome measures the total number of participants in whom any postoperative complications are identified and managed during the follow-up period. Complications include both major events (e.g., deep vein thrombosis, surgical site infections) and minor issues (e.g., swelling, delayed wound healing, pain requiring intervention). The detection is based on clinical assessment during nurse-led telehealth or traditional in-person consultations.
次要结局
- Change in Functional Recovery as Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline (pre-surgery) and 3 months post-surgery)
- The Chinese version of the Mobile Health App Usability Questionnaire (I-C-MAUQ) (Telehealth group)(Within 4 weeks after surgery - immediately after the first telehealth follow-up consultation)
- Patient Satisfaction with Nursing Consultation(Within 4 weeks post-surgery, following the first consultation)
- Unplanned Hospital Readmissions within 28 Days Post-Surgery(28 days post-surgery)
- Number of Visits to Accident and Emergency (A&E) Department within 3 Months Post-Surgery(3 months post-surgery)
- Direct out-of-pocket travel cost (HK $)(Day of the first follow-up consultation (within 4 weeks after surgery))
- Total travel time to clinic (minutes)(Day of the first follow-up consultation (within 4 weeks after surgery))
- Nursing preparation time before follow-up consultation (minutes)(Day of the first follow-up consultation (within 4 weeks after surgery))
- Nursing face-to-face consultation time (minutes)(Day of the first follow-up consultation (within 4 weeks after surgery))
研究者
Wong King Sum
Associated Nurse Consultant (O&T)
Hospital Authority, Hong Kong