Assessing the Feasibility of the MSPT Device in Routine Clinical Practice in the Swiss Healthcare System

Study Overview
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Brief Summary
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The Multiple Sclerosis Functional Composite (MSFC), a reliable and well-validated instrument, was developed as a multidimensional quantitative measure of neurologic disability in MS. However, the traditional form of the MSFC has various limitations, including the need for MS patients to be assessed in a clinical setting by trained technicians, which requires additional human resources and time in a clinical routine practice setting. Furthermore, storage of MSFC data for longitudinal comparison is difficult and time consuming. The MS Performance Test (MSPT) software tool is designed to objectively quantify the major motor, visual and cognitive function data, and quality of life outcomes, associated with MS and related disorders. This is a single center observational study that will examine the use of the MSPT in a real world setting. Study enrollment will occur at one center in Switzerland.

Detailed Description
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Study participation will be offered to MS patients either on day of clinic visit. Patient screening, consent discussion and MSPT test completion is estimated to take approximately an hour prior to the appointment with the treating physician. Participants begin with an instructional overview, which acquaints them with all elements of the MSPT. The tests will be performed in the same order and if a study participant elects to discontinue testing or skip a module, they will be asked to indicate the reasons on the screen. Each module has accompanying instructions. Upon completion of testing at first and last study visit, patients, research nurse/coordinator and treating physician will be asked to fill in a short satisfaction questionnaire related to the functionality of the MSPT. HCPs will have the ability to view de-identified longitudinal MSPT outcomes for each patient on the MSPT tool. De-identified data abstracted from each site will be stored in a cloud-based data repository. Access to the MSPT Cloud and data therein is restricted to the healthcare institution using the registered MSPT tool. The site will periodically send de-identified and encrypted aggregate data to Biogen.

Official Title
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Assessing the Feasibility of the Multiple Sclerosis Performance Test (MSPT) Device in Routine Clinical Practice in the Swiss Healthcare System

Conditions
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Multiple Sclerosis, Clinically Isolated Syndrome

Intervention / Treatment
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* Device: MSPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. Diagnosis of MS, including Clinically Isolated Syndrome (CIS) Ability to understand the audio and visual instructions for the test modules Visual function, based on the investigator's clinical judgement, that does not preclude an ability to interact with the MSPT. Exclusion Criteria: Unable or unwilling to provide informed consent. Patients under 18 years of age will be excluded. Other unspecified reasons that, in the opinion of the Sponsor-Investigator, make the patient unsuitable for participation in the demonstration project. A patient only needs to complete the assessments deemed appropriate by the Sponsor-Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MS patients including CIS<br>Patients with a diagnosis of MS, including Clinically Isolated Syndrome (CIS), who have the ability to understand the audio and visual instructions for the MSPT modules and whose visual function that does not preclude an ability to see the screen of the MSPT tool. | Device: MSPT<br>* The MS Performance Test (MSPT) software tool and accompanied hardware is an iPad®-based assessment tool, developed via collaboration between Biogen and the Cleveland Clinic Mellen Center, and designed to objectively quantify the major motor, visual and cognitive function data, and quality of life outcomes, associated with MS and related disorders.These assessment modules of the MSPT are self-administered by MS patients at the point of care and incorporate and expand upon previously validated measures of the MSFC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who complete all modules | Percentage of patients who complete all modules (out of those who initiate testing) will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients. | 2 years | 
| Percentage of patients who complete each module | Percentage of patients who complete each module (out of those who initiate each module) will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients. | 2 years | 
| Percentage of patients who skip modules | Percentage of patients who skip modules (out of those who initiate testing) will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients. | 2 years | 
| Time to complete the MSPT | Time to complete the MSPT will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients. | 2 years | 
| Time to complete the individual MSPT modules | Time to complete the individual MSPT modules will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients. | 2 years | 
| Frequency of reasons for not completing test modules | Frequency of reasons for not completing test modules will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients. | 2 years | 
| Frequency distribution of demographic characteristics of patients who fail to complete specific MSPT modules | Frequency distribution of demographic characteristics (as captured in the MyHealth module) of patients who fail to complete specific MSPT modules will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net promoter score based on satisfaction questionnaires | Net promoter score based on satisfaction questionnaires conducted with patients to probe about experience interfacing the MSPT | 2 years | 
| Net promoter score based on patient questionnaire | Net promoter score based on patient questionnaire related to perceived benefit of the MSPT for improved monitoring of MS disease progression | 2 years | 
| Net promoter score based on treating physician and administrator questionnaire for improved monitoring of MS disease progression | Net promoter score based on treating physician and administrator questionnaire related to perceived benefit of the MSPT for improved monitoring of MS disease progression | 2 years | 
| Net promoter score based on satisfaction questionnaires conducted with treating physicians and the MSPT administrator to probe about experience | Net promoter score based on satisfaction questionnaires conducted with treating physicians and the MSPT administrator to probe about experience interfacing the MSPT | 2 years | 
| Change in MSPT outcomes in patient subgroups of interest at baseline and at each visit over time | Change in MSPT outcomes in patient subgroups of interest at baseline and at each visit over time (e.g., newly diagnosed, untreated RRMS, patients with cognitive impairment, patients with cognitive impairment but only mild physical disability, patients of different area of origin) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, CIS, MSFC, Contrast Sensitivity Test, Walking Speed Test, 25 foot walk, Manual Dexterity Test, Processing Speed Test, self-administrating, medical device