Arthroplasty, Replacement, Knee, Osteoarthritis, Knee
Conditions
Keywords
Total knee replacement, Knee arthroplasty, Postoperative care, Nurse-led telehealth, Telemedicine nursing consultation, Telehealth follow-up, Orthopedic nursing, Surgical complication detection, Recovery after knee surgery, Patient satisfaction, Outpatient follow-up care, Digital health interventions, HA Go mobile application, Remote patient monitoring
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.
Interventions
PROCEDURENurse-Led Telehealth Consultation
Participants receive scheduled postoperative nursing consultations delivered remotely via the HA Go mobile application, a secure, hospital-approved telehealth platform. Consultations occur approximately two weeks after total knee replacement surgery, with additional sessions arranged as clinically needed within the first month post-surgery. Each telehealth session lasts about 20 to 30 minutes and includes assessment of recovery progress, monitoring for complications, patient education, and guidance on rehabilitation exercises. Patients receive technical support to facilitate effective use of the telehealth platform. This intervention leverages virtual care technology to provide convenient, accessible nursing follow-up without requiring in-person clinic visits.
PROCEDURETraditional In-Person Nursing Consultation
Participants receive scheduled postoperative nursing consultations in person at the Specialist Outpatient Department. Each consultation lasts approximately 20 to 30 minutes and includes physical assessment, monitoring for complications, patient education, and rehabilitation guidance. Follow-up visits are typically scheduled two weeks after total knee replacement surgery, with additional visits as clinically indicated. This intervention represents standard postoperative nursing care delivered face-to-face.
Sponsors
Hospital Authority, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study uses a parallel-group design in which participants are randomly assigned to one of two groups: the nurse-led telehealth consultation group or the traditional in-person nursing consultation group. Both groups receive follow-up care after total knee replacement surgery, and their outcomes will be compared to evaluate the effectiveness of telehealth versus in-person consultations. Randomization is performed using block randomization with concealed allocation to ensure balance between groups and minimize selection bias.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Hong Kong
Contacts
Primary ContactKing Sum Wong, ANC, RN, BSN, MScHSM
Outcome results
None listed