NCT07058623

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

June 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

January 5, 2026

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

June 10, 2025

Last Update Submit

December 30, 2025

Conditions

Keywords

Total knee replacementKnee arthroplastyPostoperative careNurse-led telehealthTelemedicine nursing consultationTelehealth follow-upOrthopedic nursingSurgical complication detectionRecovery after knee surgeryPatient satisfactionOutpatient follow-up careDigital health interventionsHA Go mobile applicationRemote patient monitoring

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Postoperative Complications Detected Within Four Weeks Following Total Knee Replacement

    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.

    Within 4 weeks (28 days) post-surgery

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Nurse-Led Telehealth Consultation

EXPERIMENTAL

Participants receive postoperative nursing follow-up via virtual consultations using the HA Go mobile app, a secure, hospital-approved telehealth platform. Nurses monitor recovery, assess for complications, provide education, and manage minor issues remotely. Consultations are scheduled 2 weeks post-surgery, with additional sessions as clinically indicated, lasting approximately 20-30 minutes each. Support is provided to assist patients unfamiliar with the technology. This arm tests the effectiveness of remote nursing care compared to traditional in-person visits.

Procedure: Nurse-Led Telehealth Consultation

Traditional In-Person Nursing Consultation

ACTIVE COMPARATOR

Participants attend face-to-face postoperative nursing consultations at the Specialist Outpatient Department. Nurses perform physical assessments, monitor recovery progress, detect complications, provide education, and manage minor issues in-person. Follow-up visits are scheduled 2 weeks after surgery, with additional visits as needed. Consultations typically last 20-30 minutes. This arm represents standard care and serves as the active comparator to the telehealth intervention.

Procedure: Traditional In-Person Nursing Consultation

Interventions

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.

Also known as: Telehealth Nursing Consultation, Virtual Nurse Consultation, Remote Nursing Follow-Up, Telemedicine Nursing Care, HA Go App Nursing Consultation, Remote Postoperative Nursing
Nurse-Led Telehealth 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.

Also known as: Face-to-Face Nursing Consultation, In-Clinic Nursing Follow-Up, Standard Nursing Consultation, Outpatient Nursing Visit, Postoperative In-Person Nursing Care
Traditional In-Person Nursing Consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tseung Kwan O Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (12)

  • Zhao R, Cheng L, Zheng Q, Lv Y, Wang YM, Ni M, Ren P, Feng Z, Ji Q, Zhang G. A Smartphone Application-Based Remote Rehabilitation System for Post-Total Knee Arthroplasty Rehabilitation: A Randomized Controlled Trial. J Arthroplasty. 2024 Mar;39(3):575-581.e8. doi: 10.1016/j.arth.2023.08.019. Epub 2023 Aug 11.

  • Windsor EN, Sharma AK, Gkiatas I, Elbuluk AM, Sculco PK, Vigdorchik JM. An Overview of Telehealth in Total Joint Arthroplasty. HSS J. 2021 Feb;17(1):51-58. doi: 10.1177/1556331620972629. Epub 2021 Feb 21.

  • Visperas AT, Greene KA, Krebs VE, Klika AK, Piuzzi NS, Higuera-Rueda CA. A Web-Based Interactive Patient-Provider Software Platform Does Not Increase Patient Satisfaction or Decrease Hospital Resource Utilization in Total Knee and Hip Arthroplasty Patients in a Single Large Hospital System. J Arthroplasty. 2021 Jul;36(7):2290-2296.e1. doi: 10.1016/j.arth.2021.01.037. Epub 2021 Jan 21.

  • Shan Y, Ji M, Xie W, Li R, Qian X, Zhang X, Hao T. Chinese Version of the Mobile Health App Usability Questionnaire: Translation, Adaptation, and Validation Study. JMIR Form Res. 2022 Jul 6;6(7):e37933. doi: 10.2196/37933.

  • Pitaro NL, Barbera JP, Ranson WA, Zubizarreta N, Poeran J, Chen DD, Moucha CS, Hayden BL. Evaluating Resource Utilization for In-Person and Virtual Joint Classes in Total Joint Arthroplasty: An Analysis of Attendance Patterns at a Large Metropolitan Health System. J Arthroplasty. 2022 Sep;37(9):1708-1714. doi: 10.1016/j.arth.2022.03.079. Epub 2022 Apr 1.

  • McKeon JF, Alvarez PM, Vajapey AS, Sarac N, Spitzer AI, Vajapey SP. Expanding Role of Technology in Rehabilitation After Lower-Extremity Joint Replacement: A Systematic Review. JBJS Rev. 2021 Sep 13;9(9). doi: 10.2106/JBJS.RVW.21.00016.

  • Hofmann UK, Hildebrand F, Mederake M, Migliorini F. Telemedicine in orthopaedics and trauma surgery during the first year of COVID pandemic: a systematic review. BMC Musculoskelet Disord. 2023 Feb 7;24(1):101. doi: 10.1186/s12891-023-06194-3.

  • Fahey E, Elsheikh MFH, Davey MS, Rowan F, Cassidy JT, Cleary MS. Telemedicine in Orthopedic Surgery: A Systematic Review of Current Evidence. Telemed J E Health. 2022 May;28(5):613-635. doi: 10.1089/tmj.2021.0221. Epub 2021 Aug 10.

  • Fabres Martin C, Ventura Parellada C, Herrero Anton de Vez H, Ordonez Urgiles CE, Alonso-Rodriguez Piedra J, Mora Guix JM. Telemedicine approach for patient follow-up after total knee and reverse total shoulder arthroplasty: a pilot study. Int J Comput Assist Radiol Surg. 2023 Mar;18(3):595-602. doi: 10.1007/s11548-022-02784-z. Epub 2022 Nov 23.

  • El Ashmawy AH, Dowson K, El-Bakoury A, Hosny HAH, Yarlagadda R, Keenan J. Effectiveness, Patient Satisfaction, and Cost Reduction of Virtual Joint Replacement Clinic Follow-Up of Hip and Knee Arthroplasty. J Arthroplasty. 2021 Mar;36(3):816-822.e1. doi: 10.1016/j.arth.2020.08.019. Epub 2020 Aug 15.

  • Bovonratwet P, Song J, LaValva SM, Chen AZ, Ondeck NT, Blevins JL, Su EP. Telemedicine in Arthroplasty Patients: Which Factors Are Associated With High Satisfaction? Arthroplast Today. 2024 Jan 2;25:101285. doi: 10.1016/j.artd.2023.101285. eCollection 2024 Feb.

  • American Academy of Orthopaedic Surgeons. (2024). Total knee replacement. OrthoInfo. Retrieved January 8, 2025, from https://orthoinfo.aaos.org/en/treatment/total-knee-replacement

    RESULT

MeSH Terms

Conditions

Osteoarthritis, KneePatient Satisfaction

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

King Sum Wong, ANC, RN, BSN, MScHSM

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Nurse Consultant (O&T)

Study Record Dates

First Submitted

June 10, 2025

First Posted

July 10, 2025

Study Start

September 10, 2025

Primary Completion

February 28, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 5, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Demographics and Baseline Data: Including age, sex, and pre-operative ASA status. Primary Outcome: Data on the detection of post-operative complications within four weeks. Secondary Outcomes: Knee Injury and Osteoarthritis Outcome Score (KOOS) results , Mobile Health App Usability Questionnaire (I-C-MAUQ) scores , patient satisfaction surveys , healthcare utilization (unplanned readmissions, A\&E visits) , and cost-effectiveness data (travel/consultation time). Adherence Data: Participant attendance and completion rates for scheduled consultations.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Start Date: Data will be available beginning 6 months after the publication of the primary manuscript. Justification: This is a standard academic practice that allows the primary research team a fair and exclusive period to analyze and publish their main findings before sharing the data. End Date: Data will be available for five years following the study's completion date (as defined in this registry).
Access Criteria
Access will be granted to qualified academic researchers for legitimate research purposes. Approved requesters will receive the de-identified IPD set, Study Protocol, Statistical Analysis Plan (SAP), and a blank Informed Consent Form (ICF). To request access, researchers must submit a formal proposal to the Principal Investigator. All requests require review by the study team and final approval from the Hospital Authority Central Institutional Review Board (HA Central IRB). An executed data-sharing agreement is mandatory before data transfer. Upon full approval, data will be shared via a secure, encrypted method.

Locations