Relapsing Remitting Multiple SclerosisILLUMINATENCT05949580
Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
An observational study of Relapsing Remitting Multiple Sclerosis, run by Hoffmann-La Roche at 7 sites in 3 countries.
Trial summary
The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- MS Care Platform (icobrain ms and icompanion ms)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 21 Oct 2024to 31 Mar 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participants with MS are enrolled in this study. Participants with RRMS were chosen because most available disease modifying therapies (DMTs) are approved for this subgroup, and hence guiding care in this population is most relevant.
Who may be able to join
- Able to comply with the study protocol, including having a smartphone and being able and willing to access the icompanion ms patient app on a regular basis. To use all functionalities of the icompanion ms patient app, the user's smartphone must comply with the minimum system requirements (Android version 5.0 or above, iOS version 11 or above)
- Have a valid email address (for registration of icompanion ms)
- Have a definite diagnosis of RRMS
- Time since MS diagnosis ≥1 year
- Medical history recorded for at least 1 year before enrollment
- Expanded Disability Status Scale (EDSS) <5.5
Who cannot join
- Any contra-indications to using icompanion ms patient app or website, as per the investigator's discretion
- Inability to complete an MRI
- Currently involved in an interventional trial
- Diagnosis of progressive MS (primary progressive multiple sclerosis [PPMS] or secondary progressive multiple sclerosis [SPMS])
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States3 sites
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Jersey Shore University Medical Centre
Neptune City, New Jersey, 07753
Germany2 sites
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 01307
Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim
Sinsheim, 74889
Spain2 sites
Hospital General Universitario Dr. Balmis
Alicante/alacant, Alicante, 03010
Hospital Universitario de Gran Canaria
Las Palmas, 35010
About this study
Official title: Study to Evaluate the Usability of Introducing Integrated Digital Solutions Into Clinical Practice and the Value of Their Use in the Medical Care of Patients With Multiple Sclerosis (MS)
The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice.
This is a two-year prospective data collection study with additional data collection at baseline evaluating medical practice over a period of at least one year before the introduction of the MS care management platform.
Read the detailed description
The MS care management platform consists of:
- icobrain ms, a cloud-based artificial intelligence (AI) solution to quantify brain volume and brain abnormalities and changes thereof on magnetic resonance imaging (MRI) scans and thereby providing insights into subclinical changes during disease progression in MS.
- icompanion ms, which consists of i) A free participant mobile application (app) and website to keep track of participant reported health and medications and prepare participants for the next consultation. ii) A web portal for healthcare professionals (HCPs), which is accessible via web browser. The MS care team will be able to access the participants' data entered via the participant app (active linking of systems by the participant required), as well as their participants' MRI images and icobrain ms volumetric brain reports automatically imported by the hospital picture archiving and communications system (PACS).
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- MS Care Platform (icobrain ms and icompanion ms)
- Keywords
- icobrain, icompanion, Multiple Sclerosis, Medical device, Patient app, Digital, Care management, Magnetic resonance imaging (MRI), Deep learning, Artificial Intelligence (AI), Patient Reported Outcomes (PRO)
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS Care Platform (icobrain ms and icompanion ms)Device
The MS care management platform consists of the following components:
- icobrain ms which is a a cloud-based solution to quantify brain volume and brain abnormalities and changes thereof on MRI scans;
- icompanion ms which consists of free participant mobile application (app) and a web portal for HCPs.
The information collected in the icompanion ms patient app and icobrain ms is then brought together in the icompanion ms HCP web portal which allows a comprehensive overview of disease data for every single participant.
| Study group | Role | What they receive |
|---|---|---|
| People with RRMS | Participants with relapsing-remitting multiple sclerosis (RRMS) will have to complete various questionnaire from which data will be collected for patient-reported outcomes (PROs) using the icompanion patient app and the HCPs will complete various questionnaires using the icompanion HCP portal. Receives: Device: MS Care Platform (icobrain ms and icompanion ms) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCPs: Median of the System Usability Scale (SUS) Score Reported by Radiologists and Neurologists at Month 6
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: <51=awful; 51-68=poor; 68=okay; 68-80.3=good; > 80.3=excellent; 100=best imaginable score.
Measured: Month 6
HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 12
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: <51=awful; 51-68=poor; 68=okay; 68-80.3=good; > 80.3=excellent; 100=best imaginable score.
Measured: Month 12
HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 24
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: <51=awful; 51-68=poor; 68=okay; 68-80.3=good; > 80.3=excellent; 100=best imaginable score.
Measured: Month 24
Participants: Median Score of the mHealth App Usability Questionnaire (MAUQ) [MAUQ_E (Ease of Use) MAUQ_I (Interface and Satisfaction)] at Baseline
MAUQ_E and MAUQ_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Measured: Baseline
Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 12
MAUQ_E and MAUQ_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Measured: Month 12
Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 24
MAUQ_E and MAUQ_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Measured: Month 24
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by Semi-structured Interviews (SSIs) at Month 6
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
Measured: Baseline to Month 6
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by SSIs at Month 12
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
Measured: Baseline to Month 12
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by SSIs at Month 24
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
Measured: Baseline to Month 24
Secondary outcomes (17)
Change From Baseline in Time Needed for MRI Review, Assessed by SSIs of Radiologists
To assess the change in time required for MRI review, the radiologists are required to answer a set of 2 questions; one question with a yes/no response (whether icobrain ms save time when reading an MRI) and another question where in the HCPs will express the time saved in minutes (absolute) and in percentage (relative) while reading an MRI while using icobrain ms.
Measured: Baseline, 6, 12 and 24 months
Change From Baseline in Time Needed for Visit Preparation, Assessed by SSIs of Neurologists
To assess the change in time required for visit preparation, the neurologist is required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and if the response selected is "agree" a free text field is available to explain the reason for agreeing.
Measured: Baseline, 6, 12 and 24 months
Change From Baseline in Health Literacy Assessed by the Health Literacy Questionnaire (HLQ)
The HLQ explores dimensions of health literacy such as social support relationship with caregivers, health information evaluation or ability to engage with caregivers. Participants will be asked to rate "How strongly do you disagree or agree with the following statements?". The options provided are: strongly disagree, disagree, agree and strongly agree, which are scored from 1 to 4, respectively. In 2nd part of the HLQ, participants will be asked "How easy or difficult are the following tasks for you to do now?" The options for these scales are: cannot do, usually difficult, sometimes difficult, usually easy and always easy, which were scored from 1 to 5, respectively. For both the parts higher the score higher is the health literacy of a participant.
Measured: Baseline, 12 and 24 months
Change From Baseline in Participant Autonomy Assessed by the Patient Activation Measure® 13 (PAM13)
PAM 13 is a measure used to assess the participant knowledge, skill, and confidence for self-management of health, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Scores will be summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher participant activation.
Measured: Baseline, 12 and 24 months
Change From Baseline in Medication Adherence, Assessed by the Morisky Medication Adherence Scale (MMAS)
The MMAS 8-item questionnaire is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. A positive change score will reflect an improvement in the adherence.
Measured: Baseline, 12 and 24 months
Time in Days Needed for the Successful Installation and Integration of all Components in the MS Care Management Platform
Measured: Baseline
Number of HCPs at Each Study Center Registered on the MS Care Management Platform
Measured: Up to 24 months
Factors Influencing HCPs Adoption to MS Care Management Platform Measured by SSIs
Factors influencing HCPs adoption to the MS care platform will be measured using the SSIs. The questionnaire includes three items with a yes/no response along with a free text field to provide an elaboration based on the responses selected.
Measured: Baseline, 6, 12 and 24 months
Number of MRI Scans per Study Center Analyzed With icobrain ms
Measured: Baseline, 6, 12, 18 and 24 months
Level of Engagement on Platform Assessed Monthly by the Number of Logins and Time Spent on Individual Portal Pages in the HCP Portal
Measured: Up to 24 months
Factors Influencing HCPs Adherence Measured by SSIs
Factors influencing HCPs adherence to the MS care platform will be measured using the SSIs. The questionnaire includes three item with a yes/no response along with a free text field to provide an elaboration if 'yes' is selected.
Measured: Baseline, 6, 12 and 24 months
Number of Participants at Each Study Center That Register for the icompanion ms Patient app
Measured: Up to 24 months
Reasons for not Registering for icompanion ms Patient app as Described by the HCP Through the icompanion ms HCP Portal
Measured: Up to 24 months
Average Number of Activities in the icompanion ms Patient app per Patient per Month
Measured: Up to 24 months
Number of Participants Using the icompanion ms Patient app With at Least 2 Activities Within 2 Months, Assessed per Month
Measured: Baseline up to 2 months of enrollement (Up to approximately 12 months)
Number of Participants That Stop Using the icompanion ms Patient app (no Activity for More Than 4 Months), Assessed per Month
Measured: Up to 24 months
Reasons for not Using the icompanion ms Patient app Regularly as Described by HCP Through the icompanion ms HCP Portal
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start21 Oct 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Why it stopped: Transition of study Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- icometrix
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, icometrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949580
- Sponsor's protocol ID
- MN44358
- Acronym
- ILLUMINATE
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: At this stage of our research, we do not intend to share externally individual patient-level data generated by this study. Nonetheless, it remains our objective to ensure the dissemination of our collective insights and findings from the study to the scientific and medical community. All external publications will be appropriately agreed upon by the study collaborators and coordinated as per our publication plan.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Usability of Introducing Integrated Digital Solutions Into Clinical Practice and the Value of Their Use in the Medical Care of Patients With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT05949580
- Acronym / sponsor ID
- ILLUMINATE / MN44358
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- icobrain, icompanion, Multiple Sclerosis, Medical device, Patient app, Digital, Care management, Magnetic resonance imaging (MRI)
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Transition of study Sponsor.
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- icometrix
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 18 Jul 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.
The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice.
This is a two-year prospective data collection study with additional data collection at baseline evaluating medical practice over a period of at least one year before the introduction of the MS care management platform.
Detailed description
The MS care management platform consists of:
- icobrain ms, a cloud-based artificial intelligence (AI) solution to quantify brain volume and brain abnormalities and changes thereof on magnetic resonance imaging (MRI) scans and thereby providing insights into subclinical changes during disease progression in MS.
- icompanion ms, which consists of i) A free participant mobile application (app) and website to keep track of participant reported health and medications and prepare participants for the next consultation. ii) A web portal for healthcare professionals (HCPs), which is accessible via web browser. The MS care team will be able to access the participants' data entered via the participant app (active linking of systems by the participant required), as well as their participants' MRI images and icobrain ms volumetric brain reports automatically imported by the hospital picture archiving and communications system (PACS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with RRMS | – | Device: MS Care Platform (icobrain ms and icompanion ms)Participants with relapsing-remitting multiple sclerosis (RRMS) will have to complete various questionnaire from which data will be collected for patient-reported outcomes (PROs) using the icompanion patient app and the HCPs will complete various questionnaires using the icompanion HCP portal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with MS are enrolled in this study. Participants with RRMS were chosen because most available disease modifying therapies (DMTs) are approved for this subgroup, and hence guiding care in this population is most relevant.
Key inclusion criteria (6 listed)
- Able to comply with the study protocol, including having a smartphone and being able and willing to access the icompanion ms patient app on a regular basis. To use all functionalities of the icompanion ms patient app, the user's smartphone must comply with the minimum system requirements (Android version 5.0 or above, iOS version 11 or above)
- Have a valid email address (for registration of icompanion ms)
- Have a definite diagnosis of RRMS
- Time since MS diagnosis ≥1 year
- Medical history recorded for at least 1 year before enrollment
Key exclusion criteria (4 listed)
- Any contra-indications to using icompanion ms patient app or website, as per the investigator's discretion
- Inability to complete an MRI
- Currently involved in an interventional trial
- Diagnosis of progressive MS (primary progressive multiple sclerosis [PPMS] or secondary progressive multiple sclerosis [SPMS])
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 |
|---|---|---|
| MS Care Platform (icobrain ms and icompanion ms)The MS care management platform consists of the following components: 1. icobrain ms which is a a cloud-based solution to quantify brain volume and brain abnormalities and changes thereof on MRI scans; 2. icompanion ms which consists of free participant mobile application (app) and a web portal for HCPs. The information collected in the icompanion ms patient app and icobrain ms is then brought together in the icompanion ms HCP web portal which allows a comprehensive overview of disease data for every single participant. | Device | People with RRMS |
Primary outcome
HCPs: Median of the System Usability Scale (SUS) Score Reported by Radiologists and Neurologists at Month 6
Time frame: Month 6
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: <51=awful; 51-68=poor; 68=okay; 68-80.3=good; > 80.3=excellent; 100=best imaginable score.
HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 12
Time frame: Month 12
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: <51=awful; 51-68=poor; 68=okay; 68-80.3=good; > 80.3=excellent; 100=best imaginable score.
HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 24
Time frame: Month 24
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: <51=awful; 51-68=poor; 68=okay; 68-80.3=good; > 80.3=excellent; 100=best imaginable score.
Participants: Median Score of the mHealth App Usability Questionnaire (MAUQ) [MAUQ_E (Ease of Use) MAUQ_I (Interface and Satisfaction)] at Baseline
Time frame: Baseline
MAUQ_E and MAUQ_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 12
Time frame: Month 12
MAUQ_E and MAUQ_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 24
Time frame: Month 24
MAUQ_E and MAUQ_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by Semi-structured Interviews (SSIs) at Month 6
Time frame: Baseline to Month 6
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by SSIs at Month 12
Time frame: Baseline to Month 12
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by SSIs at Month 24
Time frame: Baseline to Month 24
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
17 secondary outcomes
Change From Baseline in Time Needed for MRI Review, Assessed by SSIs of Radiologists
Time frame: Baseline, 6, 12 and 24 months
Change From Baseline in Time Needed for Visit Preparation, Assessed by SSIs of Neurologists
Time frame: Baseline, 6, 12 and 24 months
Change From Baseline in Health Literacy Assessed by the Health Literacy Questionnaire (HLQ)
Time frame: Baseline, 12 and 24 months
Change From Baseline in Participant Autonomy Assessed by the Patient Activation Measure® 13 (PAM13)
Time frame: Baseline, 12 and 24 months
Change From Baseline in Medication Adherence, Assessed by the Morisky Medication Adherence Scale (MMAS)
Time frame: Baseline, 12 and 24 months
Time in Days Needed for the Successful Installation and Integration of all Components in the MS Care Management Platform
Time frame: Baseline
Number of HCPs at Each Study Center Registered on the MS Care Management Platform
Time frame: Up to 24 months
Factors Influencing HCPs Adoption to MS Care Management Platform Measured by SSIs
Time frame: Baseline, 6, 12 and 24 months
Number of MRI Scans per Study Center Analyzed With icobrain ms
Time frame: Baseline, 6, 12, 18 and 24 months
Level of Engagement on Platform Assessed Monthly by the Number of Logins and Time Spent on Individual Portal Pages in the HCP Portal
Time frame: Up to 24 months
Factors Influencing HCPs Adherence Measured by SSIs
Time frame: Baseline, 6, 12 and 24 months
Number of Participants at Each Study Center That Register for the icompanion ms Patient app
Time frame: Up to 24 months
Reasons for not Registering for icompanion ms Patient app as Described by the HCP Through the icompanion ms HCP Portal
Time frame: Up to 24 months
Average Number of Activities in the icompanion ms Patient app per Patient per Month
Time frame: Up to 24 months
Number of Participants Using the icompanion ms Patient app With at Least 2 Activities Within 2 Months, Assessed per Month
Time frame: Baseline up to 2 months of enrollement (Up to approximately 12 months)
Number of Participants That Stop Using the icompanion ms Patient app (no Activity for More Than 4 Months), Assessed per Month
Time frame: Up to 24 months
Reasons for not Using the icompanion ms Patient app Regularly as Described by HCP Through the icompanion ms HCP Portal
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. At this stage of our research, we do not intend to share externally individual patient-level data generated by this study. Nonetheless, it remains our objective to ensure the dissemination of our collective insights and findings from the study to the scientific and medical community. All external publications will be appropriately agreed upon by the study collaborators and coordinated as per our publication plan.
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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.
Clinical Trials study director
icometrix
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Hoffmann-La Roche at 7 sites in 3 countries.
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 6 inclusion and 4 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: paused, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Germany, Spain. 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?
Results are not available in the source record.
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?
HCPs: Median of the System Usability Scale (SUS) Score Reported by Radiologists and Neurologists at Month 6 (time frame: Month 6). The study lists 9 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 20 Jul 2026.