DESIGNING A CLINICAL TRIALS FRAMEWORK FOR WEARABLE TECHNOLOGIES AT SEHA VIRTUAL HOSPITAL IN SAUDI ARABIA

Abstract

The purpose of this research is to design a clinical trials framework for wearable technologies at Seha Virtual Hospital (SVH) in Saudi Arabia. The framework aims to evaluate the usability, effectiveness, and impact of wearable technologies on patient outcomes in a virtual care setting, aligning with the national strategy for digital health transformation. The research also seeks to establish benchmarks and generate high-quality evidence on the efficacy of these technologies for digital health in Saudi Arabia. The SVH, as a pioneering digital health centre, recognises the potential of wearable technologies to revolutionise healthcare by enabling remote monitoring and real-time data collection. The proposed framework will facilitate the integration of these technologies into clinical trials, contributing to evidence-based practices and improved patient care. The research methodology involved a systematic literature review to identify key themes and challenges in integrating wearable technologies into clinical trials. The review adhered to the PRISMA guidelines and included studies published between 2014 and 2024 that examined the use of wearable technologies in clinical trials for virtual healthcare delivery. Thematic analysis was employed to identify key themes and challenges. The findings highlighted the importance of usability and positive user experience, seamless data integration and high data quality, patient-centric design to promote adherence, the value of real-world evidence and feasibility studies, addressing regulatory and ethical considerations, and ensuring successful technology integration. The research also identified key benchmarks from existing clinical trials in different countries, including usability and patient-centred design, real-world data integration, methodological rigour and validation, ethical and regulatory compliance, personalised treatment plans and data accuracy, and hybrid models and flexibility. Results the comprehensive clinical trials framework was proposed. The framework incorporates needs assessment, technical performance evaluation, usability testing, feasibility assessment, and outcome measurement. It also emphasises ethical considerations, regulatory compliance, and data security. The implementation of this framework at SVH will enable the effective evaluation of wearable technologies, leading to improved patient monitoring, enhanced virtual care delivery, and ultimately, better patient outcomes. Keywords: clinical trials, wearable technologies, virtual healthcare, usability, and framework.