Remote MS Care in Antwerp

NCT06179758 | Active Not Recruiting

• 1 other identifier: 3258
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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:
• To evaluate the relationship between MS patients' subjective health experience, disease control and disease acceptation (by using the Health Monitor) and adherence and usability
• 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
• 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)
• 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:
• 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
• To evaluate the app features most used by patient users
• To evaluate the web portal features most used by HCP users

Conditions

Multiple Sclerosis

Keywords

remote monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• the correlation between MS patients' subjective health experience, disease control and disease acceptation (by using the Health Monitor) and adherence and usability

  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

  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

  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

  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 Outcomes (3)

• the concordance between patient-reported and clinician-assessed values of some of the parameters collected by the icompanion default dataset, when available

  continuously throughout the study, for an estimated duration of 6 to 12 months

• the app features most used by patient users

  continuously throughout the study, for an estimated duration of 6 to 12 months

• the web portal features most used by health care professional users

  continuously throughout the study, for an estimated duration of 6 to 12 months

Study Arms (1)

open-label interventional arm

EXPERIMENTAL

Device: icompanion app

Interventions

icompanion app DEVICE

use of the icompanion app as a digital telemonitoring solution

open-label interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Age 18 or above,
• Able to give informed consent (written or verbal with witness signing on behalf of patient) and to adhere to study procedures,
• Dutch/Flemish speaking.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (3)

University Hospital Antwerp

Edegem, Antwerpen, 2650, Belgium

Location

ZAS Middelheim

Antwerp, 2020, Belgium

Location

AZ Klina

Brasschaat, 2930, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: December 22, 2023
• Study Start: May 23, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-01

Locations

BE (3)