Clinical trial NCT05949580: Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
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)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: icometrix
First posted: 2023-07-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The MS care management platform consists of:

A) 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.

B) 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 \[SPMS\])

Primary outcomes:
measure: HCPs: Median of the System Usability Scale (SUS) Score Reported by Radiologists and Neurologists at Month 6
timeFrame: Month 6
measure: HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 12
timeFrame: Month 12
measure: HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 24
timeFrame: Month 24
measure: Participants: Median Score of the mHealth App Usability Questionnaire (MAUQ) [MAUQ_E (Ease of Use) MAUQ_I (Interface and Satisfaction)] at Baseline
timeFrame: Baseline
measure: Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 12
timeFrame: Month 12
measure: Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 24
timeFrame: Month 24
measure: Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by Semi-structured Interviews (SSIs) at Month 6
timeFrame: Baseline to Month 6
measure: Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by SSIs at Month 12
timeFrame: Baseline to Month 12
measure: Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by SSIs at Month 24
timeFrame: Baseline to Month 24
Secondary outcomes:
measure: Change From Baseline in Time Needed for MRI Review, Assessed by SSIs of Radiologists
timeFrame: Baseline, 6, 12 and 24 months
measure: Change From Baseline in Time Needed for Visit Preparation, Assessed by SSIs of Neurologists
timeFrame: Baseline, 6, 12 and 24 months
measure: Change From Baseline in Health Literacy Assessed by the Health Literacy Questionnaire (HLQ)
timeFrame: Baseline, 12 and 24 months
measure: Change From Baseline in Participant Autonomy Assessed by the Patient Activation Measure® 13 (PAM13)
timeFrame: Baseline, 12 and 24 months
measure: Change From Baseline in Medication Adherence, Assessed by the Morisky Medication Adherence Scale (MMAS)
timeFrame: Baseline, 12 and 24 months
measure: Time in Days Needed for the Successful Installation and Integration of all Components in the MS Care Management Platform
timeFrame: Baseline
measure: Number of HCPs at Each Study Center Registered on the MS Care Management Platform
timeFrame: Up to 24 months
measure: Factors Influencing HCPs Adoption to MS Care Management Platform Measured by SSIs
timeFrame: Baseline, 6, 12 and 24 months
measure: Number of MRI Scans per Study Center Analyzed With icobrain ms
timeFrame: Baseline, 6, 12, 18 and 24 months
measure: Level of Engagement on Platform Assessed Monthly by the Number of Logins and Time Spent on Individual Portal Pages in the HCP Portal
timeFrame: Up to 24 months
measure: Factors Influencing HCPs Adherence Measured by SSIs
timeFrame: Baseline, 6, 12 and 24 months
measure: Number of Participants at Each Study Center That Register for the icompanion ms Patient app
timeFrame: Up to 24 months
measure: Reasons for not Registering for icompanion ms Patient app as Described by the HCP Through the icompanion ms HCP Portal
timeFrame: Up to 24 months
measure: Average Number of Activities in the icompanion ms Patient app per Patient per Month
timeFrame: Up to 24 months
measure: Number of Participants Using the icompanion ms Patient app With at Least 2 Activities Within 2 Months, Assessed per Month
timeFrame: Baseline up to 2 months of enrollement (Up to approximately 12 months)
measure: Number of Participants That Stop Using the icompanion ms Patient app (no Activity for More Than 4 Months), Assessed per Month
timeFrame: Up to 24 months
measure: Reasons for not Using the icompanion ms Patient app Regularly as Described by HCP Through the icompanion ms HCP Portal
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden
city: Sinsheim
country: Germany
facility: Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim
Study officials:
affiliation: icometrix
name: Clinical Trials
role: STUDY_DIRECTOR
References: