Process evaluation protocol of a trial evaluating app-based post knee arthroplasty telerehabilitation strategy in India

Background Physical rehabilitation after knee arthroplasty is essential for improving functional outcomes. However, adherence to rehabilitation is generally poor. We developed a multicomponent mobile application (TeleREhabilitation after knee ArThroplasty; TReAT app) to facilitate home-based rehabilitation. The TReAT trial is a 1:1 randomized controlled superiority trial to evaluate the clinical and cost-effectiveness of the intervention against usual care, with an embedded process evaluation. Methods and analysis Consenting individuals undergoing knee arthroplasty at a public and private tertiary care hospital in Delhi with the ability to use a smartphone were randomized to app-based or usual home-based rehabilitation and followed up at 3 and 6 months. TReAT is an mHealth intervention consisting of provision of education and exercise videos, an e-diary for self-monitoring of progress, two-way communication, and remote therapy planning by healthcare providers. Usual care varies by hospital and consists of oral or written instructions regarding rehabilitation. We use a mixed-methods convergent parallel design for process evaluation and will draw upon backend app analytics, interviews with end users, and researcher notes and observations as data sources. We will present descriptive summary for reach and effectiveness outcomes and emerging themes of qualitative data for acceptability, maintenance and context. Mixing will occur at the data collection and interpretation stage for fidelity, usage by end users, adoption, and mechanistic pathways of the various components of the intervention. Conclusions The process evaluation will provide insights into the probable uptake and scalability of TReAT intervention. The contrast of findings between public and private health care settings will inform further understanding of how the intervention plays out in different settings. The findings will guide the development of implementation strategies to improve rehabilitation care using mHealth interventions in India. Trial registration The trial was registered prospectively with the Clinical Trial Registry of India (CTRI/2024/06/068838).