Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement
- Conditions
- Arthroplasty, Replacement, KneeOsteoarthritis, Knee
- Registration Number
- NCT07058623
- Lead Sponsor
- Hospital Authority, Hong Kong
- Brief Summary
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.
- Detailed Description
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:
* Intervention arm: Nurse-led telehealth consultations delivered via a secure, hospital-approved mobile platform (the HA Go app).
* Control arm: Traditional in-person nursing consultations conducted at the Specialist Outpatient Department (SOPD).
Randomization will be performed using computer-generated block randomization with allocation concealment ensured through sealed opaque envelopes. Blinded outcome assessment and data analysis will be conducted to minimize bias.
Participants The trial will enroll adult patients (≥18 years old) who undergo first-time unilateral total knee replacement surgery at Tseung Kwan O Hospital. Eligible participants must be medically stable for discharge, have access to the necessary technology for telehealth, and provide informed consent. Patients with revision surgery, bilateral TKR, severe systemic disease (ASA Class III or above), or insufficient technological capacity will be excluded.
Interventions
Nurse-Led Telehealth:
Participants randomized to the telehealth arm will receive scheduled virtual consultations through the HA Go app. Consultations will include remote symptom assessment, wound evaluation via video, patient education on recovery and rehabilitation exercises, and management of minor complications. An executive assistant will provide technical support to patients unfamiliar with the app.
In-Person Nursing Consultation:
Participants assigned to the control group will attend face-to-face follow-up visits at the SOPD, receiving standard nursing care including physical examinations, education, and complication management.
Outcome Assessments The primary outcome is the rate of timely detection and management of post-operative complications within four weeks post-surgery. Secondary outcomes include functional recovery (assessed by validated scales such as KOOS), patient satisfaction, healthcare utilization (unplanned readmissions and emergency visits), and cost-effectiveness analyses encompassing travel and consultation time savings.
Data Collection and Management Data will be collected prospectively via electronic medical records, patient questionnaires, and telehealth system logs. Missing data will be managed using multiple imputation techniques under the assumption of missing at random. Security and confidentiality will be maintained according to Hospital Authority policies, with data encrypted and access restricted to authorized study personnel.
Significance By rigorously comparing nurse-led telehealth to traditional care, this study will generate high-quality evidence to inform post-operative management in TKR patients. Positive findings could support wider implementation of nurse-led telehealth services, improving accessibility, reducing patient burden, and optimizing healthcare resources. This model may be generalizable to other orthopedic and chronic disease care pathways.
Trial Registration and Ethics The study will be registered prior to recruitment, with ethical approval obtained from the Hospital Authority Central Institutional Review Board. Participants will provide informed consent, and the trial will adhere to CONSORT and Good Clinical Practice guidelines.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 98
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Participants with Postoperative Complications Detected Within Four Weeks Following Total Knee Replacement 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.
- Secondary Outcome Measures
Name Time Method Change in Functional Recovery as Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) Baseline (pre-surgery) and 3 months post-surgery This outcome measures participants' functional recovery and pain levels using the KOOS questionnaire, which ranges from 0 (extreme symptoms) to 100 (no symptoms). Higher scores indicate better recovery and function.
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-reported usability of the mobile-health platform will be assessed in participants randomised to the telehealth arm using the Chinese version of the Mobile Health App Usability Questionnaire (I-C-MAUQ). The 18 items are summed and rescaled to 0-100; higher scores denote better perceived usability and satisfaction with the nursing consultation.
Patient Satisfaction with Nursing Consultation Within 4 weeks post-surgery, following the first consultation A standardized Hospital Authority patient satisfaction survey for both groups. Higher scores indicate greater satisfaction with the nursing consultation.
Unplanned Hospital Readmissions within 28 Days Post-Surgery 28 days post-surgery This outcome records the number of participants who have unplanned hospital readmissions within 28 days after total knee replacement surgery.
Number of Visits to Accident and Emergency (A&E) Department within 3 Months Post-Surgery 3 months post-surgery This outcome counts participant visits to the A\&E department related to postoperative complications or concerns within 3 months after surgery.
Direct out-of-pocket travel cost (HK $) Day of the first follow-up consultation (within 4 weeks after surgery) Total patient-paid transport expenditure, including fares, parking fees, and tolls, incurred for the index post-operative follow-up consultation. The amount is reported per participant in Hong Kong dollars.
Total travel time to clinic (minutes) Day of the first follow-up consultation (within 4 weeks after surgery) Round-trip door-to-door travel duration self-reported by each participant for the index post-operative follow-up consultation. One value in minutes is recorded for every participant.
Nursing preparation time before follow-up consultation (minutes) Day of the first follow-up consultation (within 4 weeks after surgery) Clock time a nurse spends on preparatory tasks for a single post-operative follow-up consultation. These tasks include initiating or joining the telehealth platform, verifying patient identity and coaching the patient on system login. Record one value per consultation, rounded to the nearest whole minute.
Nursing face-to-face consultation time (minutes) Day of the first follow-up consultation (within 4 weeks after surgery) Elapsed clock time from the nurse's first direct interaction with the patient, either in person or on telehealth video, until completion of chart documentation and termination of the encounter. One value in whole minutes is recorded for each consultation.
Trial Locations
- Locations (1)
Tseung Kwan O Hospital
🇭🇰Hong Kong, Hong Kong
Tseung Kwan O Hospital🇭🇰Hong Kong, Hong KongKing Sum Wong, ANC, RN, BSN, MScHSMPrincipal Investigator