Multiple SclerosisReMSCANCT06179758
Remote MS Care in Antwerp
A study testing icompanion app in people with Multiple Sclerosis, run by University Hospital, Antwerp at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- icompanion app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesBelgium
- Study dates
- 23 May 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable or unwilling to use the smartphone-based icompanion app.
- Prior use of the icompanion app.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
ZAS Middelheim
Antwerp, 2020
AZ Klina
Brasschaat, 2930
University Hospital Antwerp
Edegem, Antwerpen, 2650
About this study
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.
Read more
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
- Being tested
- icompanion app
- Keywords
- remote monitoring
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
icompanion appDevice
use of the icompanion app as a digital telemonitoring solution
| Study group | Role | What they receive |
|---|---|---|
| open-label interventional arm | Experimental | Not described Receives: Device: icompanion app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: 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)
Measured: 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
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start23 May 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag div. of Johnson&Johnson SE, icometrix, Ziekenhuis Netwerk Antwerpen (ZNA), AZ Klina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179758
- Sponsor's protocol ID
- 3258
- Acronym
- ReMSCA
- Status last verified
- Jan 2025
- First submitted
- 3 Oct 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote MS Care in Antwerp
- ClinicalTrials.gov ID
- NCT06179758
- Acronym / sponsor ID
- ReMSCA / 3258
- Conditions
- Multiple Sclerosis
- Keywords
- remote monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Janssen-Cilag div. of Johnson&Johnson SE, icometrix, Ziekenhuis Netwerk Antwerpen (ZNA), AZ Klina
- Study start
- 23 May 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open-label interventional arm | Experimental | Device: icompanion app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable or unwilling to use the smartphone-based icompanion app.
- Prior use of the icompanion app.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| icompanion appuse of the icompanion app as a digital telemonitoring solution | Device | open-label interventional arm |
Primary outcome
the acceptance of a digital remote monitoring solution for MS (icompanion) (adherence number)
Time frame: month 2, month 6, month 12
measurement variable: adherence number (adherence defined as use of the icompanion app minimally once a month, score between 0 and 100%)
the usability of a digital remote monitoring solution for MS (icompanion)
Time frame: 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)
measurement variable: system usability scale (10 questions, score between 10 and 50, with higher scores meaning a better usability)
4 secondary outcomes
the correlation between MS patients' subjective health experience, disease control and disease acceptation (by using the Health Monitor) and adherence and usability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing icompanion app in people with Multiple Sclerosis, run by University Hospital, Antwerp at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the acceptance of a digital remote monitoring solution for MS (icompanion) (adherence number) (time frame: month 2, month 6, month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.