Title: Feasibility and Sensitivity of a Symptom Monitoring Application in Real Time (SMART) for Amyotrophic Lateral Sclerosis
Additional authors (in order):Jenna Wells, Brian Richburg, Joel Salinas, Jordan Green, Jukka-Pekka Onnela, James Berry
Institution name, city, state, country of additional authors: Speech & Feeding Disorders Lab, MGH Institute of Health Professions, Boston, MA, USA; Department of Neurology, Massachusetts General Hospital, Boston, MA, USA; Department of Speech, Language, and Swallowing Disorders & Reading Disabilities, Massachusetts General Hospital, Boston, MA, USA; Department of Biostatistics, Harvard T.H. Chan School of Public Health - Harvard University, Boston, MA, USA
Background: Mobile health, broadly defined as a means to monitor patients’ health status and functioning remotely, is beginning to provide novel models for gathering outcome data for clinical research. In ALS, mobile health solutions might monitor gross motor, fine motor, bulbar, and potentially respiratory function in real time. They can be used to assess subjective functional data (ALSFRS-R) more frequently than with in-person and telephone administration. Traditional observational and interventional ALS clinical research require visits every 1-3 months for clinical outcome monitoring; mobile health tools might provide continuous, objective data about patient functioning to supplement/supplant traditional outcome measures. The Onnela Lab at the Harvard T.H. Chan School of Public Health has developed a smartphone research platform called Beiwe, which can be configured to capture data from various sensors. This flexible design has facilitated its use for mobile health monitoring in a variety of diseases, including different psychiatric conditions, where pilot data already exists.
Objective: We describe the design of a pilot study using smartphones to monitor the gross motor, fine motor, bulbar function, and subjective function of a cohort of people with ALS.
Methods: Participants enroll for the study at an in-person visit. Informed consent, demographics, disease history, vital capacity, ALSFRS-R, and ALS-CBS are obtained. The Beiwe app, which supports both Android and iOS, is downloaded to the participant’s phone and each participant is assigned random ID. At three months, participants will be given a choice of continuing participation or discontinuing the study. At 6 weeks, a telephone ALSFRS-R questionnaire is administered. At three and six months, ALSFRS-R, VC and ALS-CBS are obtained. Data is collected from the following sources: accelerometer, GPS, Bluetooth, Wi- Fi, screen on/off events, and communication logs. The app prompts the user to complete ALSFRS-R questionnaires, surveys, voice recordings, cough recordings, and on-screen exercises at pre-determined intervals.
Conclusions: This pilot program is aimed at monitoring gross motor, fine motor, and bulbar function in real time and gathering frequent subjective functional data from participants. We will evaluate feasibility and compliance, and generate a pilot data set for planning a larger mobile health program in people with ALS.