Remote MS Care in Antwerp (ReMSCA)

Current clinical follow-up of multiple sclerosis (MS) patients suffers from some challenges, as many patients indicate they want to take up a more active role in the decision-making process. However, more than half of MS patients do not consider themselves well informed about their disease. Communication between patients and healthcare professionals (HCPs) has also been reported to be suboptimal, with incorrect alignment between patients and HCPs as a result and relapses going undetected. Digital telemonitoring tools could play a role in educating MS patients, allowing them to take up a more active role in the clinical decision-making process. Additionally, remote monitoring could lead to a better alignment between patient and HCPs and could ultimately even lead to a more efficient clinical workflow.

In this study, the investigators will investigate an existing digital telemonitoring solution called icompanion, developed by Icometrix. icompanion is a class 1 medical device in US (Food and Drug Administration - FDA) and Europe (Medical Device Directive - MDD). Using the icompanion MS app and website, patients can keep a diary, log symptoms, and perform tests for body function, cognitive function and fatigue based on clinically validated patient-reported outcomes (PROs). In addition, MS patients can add treatment information, from disease modifying therapies (DMTs) to symptomatic and rehabilitation treatments, and set reminders on when to take or perform their treatment. Furthermore, patients can easily upload their magnetic resonance imaging (MRI) scans (via the patient website) and view them (via the patient website and app) as well as learn about topics related to MS (e.g., MS types, MRI lesions). Finally, patients can prepare their consultations using a pre-visit checklist, the answers of which are also shared with the patient's clinical team.

This study aims to evaluate the feasibility to use this app in a population of 100 MS patients in Antwerp, in three clinical centres. For this, the following objectives have been set forth:

• The primary objective is to evaluate the usability and acceptance of a digital remote monitoring solution for MS (icompanion).

• The secondary objectives are:

  1. To evaluate the relationship between MS patients' subjective health experience, disease control and disease acceptation (by using the Health Monitor) and adherence and usability
  2. To evaluate the impact of the use of the solution on the Health Monitor profile (reflecting patients' subjective health experience, disease control and disease acceptation) in a pre- versus post-intervention analysis
  3. To evaluate the impact of the solution on the MS patients' disease self-management, by use of the Multiple Sclerosis Self-Management Scale-Revised (MSSM-R)
  4. To evaluate the impact of the solution on the clinical visit workflow, by using visual analogue scales with custom questions about impact on workflow

• The tertiary objectives are:

  1. To evaluate the concordance between patient-reported and clinician-assessed values of some of the parameters collected by the icompanion default dataset (e.g., patient-reported Expanded Disability Status Scale (EDSS), daily steps), when available
  2. To evaluate the app features most used by patient users
  3. To evaluate the web portal features most used by HCP users

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: icompanion app

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara Willekens, MD, PhD; Phone Number: +3238213426; Email: barbara.willekens@uza.be
• Study Contact Backup: Name: Judith Derdelinckx, MD, PhD; Email: judith.derdelinckx@uza.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. A diagnosis of multiple sclerosis (MS, including relapsing-remitting MS, primary-progressive MS and secondary-progressive MS, in accordance with 2017 revisions of McDonald criteria and disease course definitions of Lublin,
2. Age 18 or above,
3. Able to give informed consent (written or verbal with witness signing on behalf of patient) and to adhere to study procedures,
4. Dutch/Flemish speaking.

Exclusion Criteria:

1. Unable or unwilling to use the smartphone-based icompanion app.
2. Prior use of the icompanion app.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: open-label interventional arm	Device: icompanion app; use of the icompanion app as a digital telemonitoring solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the acceptance of a digital remote monitoring solution for MS (icompanion) (adherence number)	measurement variable: adherence number (adherence defined as use of the icompanion app minimally once a month, score between 0 and 100%)	month 2, month 6, month 12
the usability of a digital remote monitoring solution for MS (icompanion)	measurement variable: system usability scale (10 questions, score between 10 and 50, with higher scores meaning a better usability)	month 2, month 6, month 12 (for patients), clinical visit 1 and 2 (for health care professionals, visit 1 between three to six months following inclusion and visit 2 between six to twelve months following inclusion, depending on individual follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the correlation between MS patients' subjective health experience, disease control and disease acceptation (by using the Health Monitor) and adherence and usability	the correlation between an individual's Health Monitor segment (4-segment segmentation approach based on a short questionnaire of 6 questions, reflecting an individual's sense of control and acceptance) and his/her adherence and estimation of the usability of the icompanion app (using the system usability scale (10 questions, score between 10 and 50, with higher scores meaning a better usability) will be assessed	month 0, month 2, month 6, month 12
the impact of the use of the solution on the Health Monitor profile (reflecting patients' subjective health experience, disease control and disease acceptation) in a pre- versus post-intervention analysis	the evolution of an individual's Health Monitor segment (4-segment segmentation approach based on a short questionnaire of 6 questions, reflecting an individual's sense of control and acceptance) before and after use of the icompanion app	month 0, month 2, month 6, month 12
the impact of the use the solution on the MS patients' disease self-management, by use of the MSSM-R	measurement variable: Multiple Sclerosis Self-Management Scale-Revised (MSSM-R, 24 questions, score between 24 and 120, with higher scores meaning a higher degree of disease self-management)	month 0, month 2, month 6, month 12
the impact of the solution on the clinical visit workflow, by using visual analogue scales with custom questions about impact on workflow	measurement variable: visual analogue scales with custom questions about impact on clinical visit (5 questions, score between 5 and 25, with higher scores meaning a better impact on the clinical visit workflow)	clinical visit 1 and 2 clinical visit 1 and 2 (for patients and health care professionals, visit 1 between three to six months following inclusion and visit 2 between six to twelve months following inclusion, depending on individual follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the concordance between patient-reported and clinician-assessed values of some of the parameters collected by the icompanion default dataset, when available	measurement variable: icompanion dataset (e.g., patient-reported Expanded Disability Status Scale (EDSS), score from 0 to 10, with lower scores meaning less disease-related signs and symptoms)	continuously throughout the study, for an estimated duration of 6 to 12 months
the app features most used by patient users	measurement variable: usage rate of the individual app features	continuously throughout the study, for an estimated duration of 6 to 12 months
the web portal features most used by health care professional users	measurement variable: usage rate of the individual features of the icompanion web portal	continuously throughout the study, for an estimated duration of 6 to 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Ziekenhuis Netwerk Antwerpen (ZNA); AZ Klina; icometrix; Janssen-Cilag div. of Johnson&Johnson SE

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: remote monitoring
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: 3258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No