The telemedical platform MyaLink for remote monitoring in myasthenia gravis - rationale and protocol for a proof of concept study.

Rationale: Myasthenia gravis (MG) is a rare, chronic neurological disorder leading to fluctuating muscle weakness and potentially life-threatening crises. Patients often require life-long specialized treatment, but timely interventions are frequently hindered by the limited availability of specialists. Telemedical solutions at specialized centers enabling patient-physician interaction hold promise in bridging this gap, but are not yet available for MG. We developed 'MyaLink,' a remote monitoring platform tailored for MG, and outline the study design assessing the platform and clinical outcomes regarding telemedical intervention. Additionally, we present study results on care-related aspects in MG prior to telemedical intervention to identify challenges in the current care provision process.

Design: The platform comprises a patient app and a physician portal, enabling systematic symptom monitoring using data from patient-reported outcome measures (PROMs), coupled devices and a communication module. The randomized controlled study included 45 study participants (SP) over a 12-weeks period, including a group receiving standard care (15 MG patients) and a group with additional telemedical treatment (30 MG patients) including assessment of PROMs, wearable data collection and telemedical check-ups. Questions regarding care-related aspects were assessed at baseline visit.

Results: Many SP (N = 33, 73.3%) communicate with the physician managing their MG via email. 73.3% (N = 33) of SP identify areas for improvement in their MG care including symptom monitoring (N = 23, 69.7%), specialist appointment availability (N = 22, 66.7%), medication (N = 22, 66.7%) and specialist accessibility (N = 20, 60.6%). Additionally, 73.3% (N = 33) reported that the effort required to manage their MG was high.

Conclusion: Our results emphasize the high demand of affected MG patients for continuous telemedicine services. MyaLink can provide such a service through personalized support based on the exchange of health data. Telemedicine solutions such as MyaLink promise to improve myasthenia care by providing accessible, patient-centred care that enables early detection of worsening symptoms and non-response to treatment.

Trial Registration: The study was registered under DRKS00029907 on August 19, 2022.