Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Janssen-Cilag div. of Johnson&Johnson SE | INDUSTRY |
| icometrix | INDUSTRY |
| Ziekenhuis Netwerk Antwerpen (ZNA) | OTHER |
| AZ Klina |
Not provided
Not provided
Not provided
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:
The tertiary objectives are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-label interventional arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| icompanion app | Device | use of the icompanion app as a digital telemonitoring solution |
|
| 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) |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Edegem | Antwerpen | 2650 | Belgium | ||
| ZAS Middelheim |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
| 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 |
| Antwerp |
| 2020 |
| Belgium |
| AZ Klina | Brasschaat | 2930 | Belgium |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |