Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis

NCT05949580 | Recruiting FDA Device

• 1 other identifier: MN44358
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 5

Brief 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. 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.

Conditions

Relapsing Remitting Multiple Sclerosis

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)

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline to Month 24

Secondary Outcomes (17)

• Change From Baseline in Time Needed for MRI Review, Assessed by SSIs of Radiologists

  Baseline, 6, 12 and 24 months

• Change From Baseline in Time Needed for Visit Preparation, Assessed by SSIs of Neurologists

  Baseline, 6, 12 and 24 months

• Change From Baseline in Health Literacy Assessed by the Health Literacy Questionnaire (HLQ)

  Baseline, 12 and 24 months

• Change From Baseline in Participant Autonomy Assessed by the Patient Activation Measure® 13 (PAM13)

  Baseline, 12 and 24 months

• Change From Baseline in Medication Adherence, Assessed by the Morisky Medication Adherence Scale (MMAS)

  Baseline, 12 and 24 months

Study Arms (1)

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.

Device: MS Care Platform (icobrain ms and icompanion ms)

Interventions

MS Care Platform (icobrain ms and icompanion ms) DEVICE

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.

People with RRMS

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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 \[SPMS\])

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• icometrix: collaborator

Study Sites (5)

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, 55422, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Jersey Shore University Medical Centre

Neptune City, New Jersey, 07753, United States

RECRUITING

Universitaetsklinikum Carl Gustav Carus an der TU Dresden

Dresden, 01307, Germany

RECRUITING

Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim

Sinsheim, 74889, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; 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 Officials

• Clinical Trials

  icometrix

  STUDY DIRECTOR

Central Study Contacts

MN44358 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: October 21, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); US (3)