Supporting the Delivery of Total Knee Replacements Care for Both Patients and Their Clinicians With a Mobile App and Web-Based Tool: Randomized Controlled Trial Protocol.

backgroundTotal knee replacement (TKR) surgeries have increased in recent years. Exercise programs and other interventions following surgery can facilitate the recovery process. With limited clinician contact time, patients with TKR have a substantial burden of self-management and limited communication with their care team, thus often fail to implement an effective rehabilitation plan.

objectiveWe have developed a digital orthopedic rehabilitation platform that comprises a mobile phone app, wearable activity tracker, and clinical Web portal in order to engage patients with self-management tasks for surgical preparation and recovery, thus addressing the challenges of adherence to and completion of TKR rehabilitation. The study will determine the efficacy of the TKR platform in delivering information and assistance to patients in their preparation and recovery from TKR surgery and a Web portal for clinician care teams (ie, surgeons and physiotherapists) to remotely support and monitor patient progress.

methodsThe study will evaluate the TKR platform through a randomized controlled trial conducted at multiple sites (N=5) in a number of states in Australia with 320 patients undergoing TKR surgery; the trial will run for 13 months for each patient. Participants will be randomized to either a control group or an intervention group, both receiving usual care as provided by their hospital. The intervention group will receive the app and wearable activity tracker. Participants will be assessed at 4 different time points: 4 weeks before surgery, immediately before surgery, 12 weeks after surgery, and 52 weeks after surgery. The primary outcome measure is the Oxford Knee Score. Secondary outcome measures include quality of life (Short-Form Health Survey); depression, anxiety, and stress (Depression, Anxiety, and Stress Scales); self-motivation; self-determination; self-efficacy; and the level of satisfaction with the knee surgery and care delivery. The study will also collect quantitative usage data related to all components (app, activity tracker, and Web portal) of the TKR platform and qualitative data on the perceptions of the platform as a tool for patients, carers, and clinicians. Finally, an economic evaluation of the impact of the platform will be conducted.

resultsDevelopment of the TKR platform has been completed and deployed for trial. The research protocol is approved by 2 human research ethics committees in Australia. A total of 5 hospitals in Australia (2 in New South Wales, 2 in Queensland, and 1 in South Australia) are expected to participate in the trial.

conclusionsThe TKR platform is designed to provide flexibility in care delivery and increased engagement with rehabilitation services. This trial will investigate the clinical and behavioral efficacy of the app and impact of the TKR platform in terms of service satisfaction, acceptance, and economic benefits of the provision of digital services.

trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12616000504415; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370536 (Archived by WebCite at http://www.webcitation.org/6oKES0Gp1).