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

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

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis; Clinically Isolated Syndrome
• Intervention / Treatment: Device: MSPT

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern, Ambulantes Neurozentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of MS, including Clinically Isolated Syndrome (CIS)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

MS patients including CIS; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Biogen
• Investigators: Principal Investigator: Robert Hoepner, PD Dr. med., University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: MS; medical device; CIS; 25 foot walk; MSFC; Contrast Sensitivity Test; Walking Speed Test; Manual Dexterity Test; Processing Speed Test; self-administrating
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CH-MSG-11563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No