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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: People with RRMS1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Month 6
2

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.

Time frame
Month 12
3

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.

Time frame
Month 24
4

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.

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline, 6, 12 and 24 months
2

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.

Time frame
Baseline, 6, 12 and 24 months
3

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.

Time frame
Baseline, 12 and 24 months
4

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.

Time frame
Baseline, 12 and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

icometrix

Collaborator