Clinical trial NCT04599023: Assessing the Feasibility of the MSPT Device in Routine Clinical Practice in the Swiss Healthcare System
Official title: Assessing the Feasibility of the Multiple Sclerosis Performance Test (MSPT) Device in Routine Clinical Practice in the Swiss Healthcare System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Clinically Isolated Syndrome
Keywords: MS
CIS
MSFC
Contrast Sensitivity Test
Walking Speed Test
25 foot walk
Manual Dexterity Test
Processing Speed Test
self-administrating
medical device
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2020-10-22
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of MS, including Clinically Isolated Syndrome (CIS)

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients who complete all modules
timeFrame: 2 years
measure: Percentage of patients who complete each module
timeFrame: 2 years
measure: Percentage of patients who skip modules
timeFrame: 2 years
measure: Time to complete the MSPT
timeFrame: 2 years
measure: Time to complete the individual MSPT modules
timeFrame: 2 years
measure: Frequency of reasons for not completing test modules
timeFrame: 2 years
measure: Frequency distribution of demographic characteristics of patients who fail to complete specific MSPT modules
timeFrame: 2 years
Secondary outcomes:
measure: Net promoter score based on satisfaction questionnaires
timeFrame: 2 years
measure: Net promoter score based on patient questionnaire
timeFrame: 2 years
measure: Net promoter score based on treating physician and administrator questionnaire for improved monitoring of MS disease progression
timeFrame: 2 years
measure: Net promoter score based on satisfaction questionnaires conducted with treating physicians and the MSPT administrator to probe about experience
timeFrame: 2 years
measure: Change in MSPT outcomes in patient subgroups of interest at baseline and at each visit over time
timeFrame: 2 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern, Ambulantes Neurozentrum
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Robert Hoepner, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: