ILLUMINATE: Design of a Real-World, Non-Interventional Study Evaluating the Usability and Value of Integrated Digital Solutions for Routine Care of Patients with Multiple Sclerosis
Tjalf Ziemssen1, Vera Zingler2, Petra Dirks2, Boris Addow2, Jelle Praet3, Annemie Ribbens3, Dirk Smeets3, Stephen Krieger4
1University Clinic Dresden, 2F. Hoffmann-La Roche Ltd, 3Icometrix, 4Mount Sinai Dept of Neurology
Objective:
To evaluate the usability and added value of a digital multiple sclerosis (MS) care management platform when introduced in the routine medical care of people with multiple sclerosis (pwMS).
Background:
Early initiation of effective disease-modifying therapies is crucial to prevent long-term disease progression in pwMS. To achieve best outcomes for patients an integrated approach is needed. Today, diagnostic tools to assess clinical and subclinical disease activity may be used insufficiently. Therefore, there exists potential to implement technology support-care paths designed to facilitate detection of worsening in disease and to improve interaction between patients and healthcare professionals (HCPs).
Design/Methods:
ILLUMINATE is a non-interventional study, designed to enroll approximately 500 patients with relapsing MS at 10 sites across 5 countries. The digital MS care management platform under investigation is composed of two certified medical devices: the icompanion MS patient app, to track health and medications and prepare patients for consultations; and icobrain MS, an artificial intelligence solution enabling standardized quantitative analysis of brain MRI data. In addition to retrospective data collection, 2 years of prospective data will be collected focusing on medical practice, as well as treatment, clinical and MRI data on disease worsening and patient-reported outcomes. The primary objective assesses the usability of the MS care management platform via the System Usability Score, reported by HCPs, and the mHealth App Usability Questionnaire, reported by patients. The perceived change in disease state, representing the value provided by the care management platform, will be assessed by semi-structured interviews.
Results:
ILLUMINATE will investigate the usability and added valued of a digital MS care management platform for the care of pwMS, with enrollment initiating early 2023.
Conclusions:
ILLUMINATE will deliver insights into MS care delivery and the impact of integrated digital tools on the detection of disease worsening.