Development and Evaluation of a mHealth app - (ReMiT-MS app) for Rehabilitation of Individuals with Relapsing-remitting Multiple Sclerosis - A Mixed Methods, Pragmatic Randomized Controlled Trial - Study Protocol

Abstract

Background: Delaying or slowing functional loss is a valuable goal of Multiple Sclerosis (MS) rehabilitation. The mHealth app-based exercise rehabilitation intervention is expected to overcome barriers related to routine care of MS. Due to the ubiquitous presence of smartphones, they offer an excellent opportunity for remote monitoring, scheduled interaction with experts, and instruction for exercise in a home environment. Challenges in MS routine care include forgotten rehabilitation steps, limited access to local MS experts, and internal barriers such as low health literacy, mobility limitations, and fatigue, alongside external obstacles like service availability and transport costs. Objectives: To develop a mHealth app that is user-centered and context-specific for rehabilitation of MS symptoms, and to evaluate its clinical and cost effectiveness in individuals with RRMS. Methods: The proposed research will be conducted in two phases; the first phase (Phase 1a) will be focused on the development of mHealth app content (ReMiT-MS app trial I). The pilot phase (Phase 1b), where a prototype of the application will be designed, and its usability will be evaluated. Finally, in the second phase (Phase 2), the clinical and cost-effectiveness of the ReMiT-MS app for the rehabilitation of individuals with RRMS will be evaluated (ReMiT-MS app trial II). Conclusion: The findings of this proposed trial may provide a telerehabilitation platform for individuals with RRMS in a resource-limited setting and establish a low-cost healthcare delivery model. In addition, the results of this research work might open a new window in healthcare delivery in India and similar settings. Trial registration: CTRI/2022/09/045266 [Registered on 06/09/2022]