IS04
Elevatems: An Iphone-Based Study in Multiple Sclerosis Patients Capturing Longitudinal Patient Reported Outcomes and Sensor Data

Thursday, May 25, 2017
B2 (New Orleans Convention Center)
John J Ko, Pharm.D., MS , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Larsson Omberg, PhD , Sage Bionetworks, Seattle, WA
Christine Suver, PhD , Sage Bionetworks, Seattle, WA
Stanley Cohan, MD, PhD , Providence Multiple Sclerosis Center, Portland, OR
Darin Okuda, MD , Department of Neurology and Neurotherapeutics, UTSouthwestern, Dallas, TX
Tiffany Surles, PharmD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Biliana Rotse, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Stefan Varga, PharmD , College of Population Heatlh, Thomas Jefferson University, Philadelphia, PA
Ashish Pradhan, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Michael Kellen, PhD , Sage Bionetworks, Seattle, WA
Daniel Grant, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Lara Mangravite, PhD , Sage Bionetworks, Seattle, WA
John J Ko, Pharm.D., MS , Novartis Pharmaceuticals Corporation, East Hanover, NJ



Background:

Smartphones are emerging as new paradigm in research allowing patients to participate in studies in their everyday lives without site visits. Coupled with the advanced sensors embedded in a modern smartphone, it is possible to collect longitudinal data that was not feasible previously. We are developing an application, called elevateMS, for a multiple sclerosis (MS) study on Apple Research Kit, which is a research platform that incorporates an electronic informed consent process and data capture, all built into the patient’s iPhone. Currently, the everyday MS patient experience outside of the neurology clinic visit or acute MS episode is not well characterized since longitudinal data on patient-reported functional changes/symptoms and sensor-based data are unavailable. elevateMS leverages the iPhone’s accelerometer, touch-screen, camera, and other sensors to collect functional performance data with activity-based tasks, patient-reported outcomes, and passive data (e.g. walking/gait dynamics).

Objectives:

elevateMS is a non-interventional study designed to provide a mechanism for real-time measurement and comparison of patient-reported outcomes (PROs), active tasks, and passive movement data between MS patients (treated/untreated) vs. non-MS subjects.

Methods:

elevateMS is a non-interventional, open to the public, study conducted entirely based on an iPhone application. iPhone users ≥18 years old, residing in the U.S. are eligible to participate by downloading the elevateMS application on the Apple App Store and completing an informed eConsent form. elevateMS captures participant data three ways: 1) active tasks 2) PROs 3) passive data collection. The active tasks include functional performance tasks that measure memory, fine motor skills, walking, and dexterity using either touch or accelerometer readings. PROs capture information on participants work productivity, functional status, medication adherence, and quality of life.

Results:

elevateMS is a new application but is based on experience in running similar non-interventional studies in other movement disorders such as Parkinson’s disease.

Conclusions:

Smartphone based research platforms have the potential to uncover new and meaningful endpoints for MS research. elevateMS will inform future inclusion of similar platforms and/or specific new digital endpoint in both controlled clinical trials and non-interventional studies.