FLOODLIGHT: smartphone-based self-monitoring is accepted by patients and provides meaningful, continuous digital outcomes augmenting conventional in-clinic multiple sclerosis measures

Objective: To report an analysis of adherence, results from a patient satisfaction questionnaire, and correlations between in-clinic tests and FLOODLIGHT (NCT02952911) measures. Background: Sensor-based, active and passive self-monitoring may be more sensitive and specific than periodic in-clinic assessments to measure progression in multiple sclerosis (MS). Design/Methods: Patients with MS (20–57 years; Expanded Disability Status Scale score 0–5.5; n=76) and healthy controls (n=25) received a preconfigured smartphone and smartwatch that prompts the user to perform the FLOODLIGHT test battery, comprising ‘active tests’ and ‘passive monitoring’, for 24 weeks. The primary analysis assessed participants’ adherence (proportion of study weeks with at least 3 days of completed active testing and at least 4 hours/day of passive monitoring) and patient satisfaction with the FLOODLIGHT monitoring solution. In-clinic tests and brain MRI assessments were performed. Secondary analyses explored whether FLOODLIGHT sensor-based outcomes 1) differed between patients with MS and healthy controls and 2) correlated with in-clinic outcomes. The correlation between FLOODLIGHT sensor-based outcomes and in-clinic tests was reported using Spearman’s correlation coefficient (SCC). Results: The analysis of adherence of patients who completed the study showed 69.5% adherence to active tests and 78.7% to passive monitoring. Satisfaction among patients with MS who completed the study (n=68) was good-to-excellent (72.7 average score out of a possible 100 at termination visit). Correlation between the Turning speed measured with the FLOODLIGHT Five-U-Turn Test vs Timed 25-Foot Walk test time was SCC=–0.501 (p Conclusions: Patients’ adherence and satisfaction combined with correlations observed between clinical and sensor-based outcomes show promising potential for the FLOODLIGHT monitoring solution to capture meaningfully relevant outcomes augmenting the clinical picture in patients with MS. Disclosure: Dr. Montalban has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Received speaking honoraria and travel expenses for scientific meetings, has been a steering committee member of clinical trials or participated in advisory boards of clinical trials in the past 3 years with Biogen Idec, Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis, Teva Pharmaceuticals, Roche, Celgene, Actelion, NMSS and MSIF. Dr. Mulero has nothing to disclose. Dr. Midaglia Fernandez has nothing to disclose. Dr. Graves has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Genentech, Inc. and S3 Group. Dr. Graves has received research support from Biogen and Genentech. Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Annexon, Symbiotix, Bionure and Neurona; he has also received travel reimbursement from F. Hoffmann-La Roche Ltd and Novartis for CD20-related meetings and presentation. Dr. Julian has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech, Inc. Dr. Julian holds stock and/or stock options in F. Hoffmann-La Roche which sponsored research in which Dr. Julian was involved as an investigator. Dr. Julian holds stock and/or stock options in F. Hoffmann-La Roche. Dr. Baker has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffman-La Roche, Ltd. Dr. Schadrack has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffman-La Roche, Ltd. Dr. Gossens has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffman-La Roche, Ltd. Dr. Gossens holds stock and/or stock options in F. Hoffmann-La Roche Ltd. Dr. Scotland has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities as an employee of F. Hoffman-La Roche, Ltd. Dr. Lipsmeier has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffmann-La Roche Ltd. Dr. Lipsmeier has received royalty, license fees, or contractual rights payments from F. Hoffmann-La Roche Ltd. Dr. Lipsmeier has received research support from F. Hoffmann-La Roche Ltd. . Dr. Bernasconi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffman-La Roche, Ltd. Dr. Belachew has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with F. Hoffman-La Roche, Ltd. Dr. Lindemann has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of F. Hoffman-La Roche, Ltd.