An observational study in Multiple Sclerosis and Clinically Isolated Syndrome, sponsored by Insel Gruppe AG, University Hospital Bern. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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 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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 182 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with diagnosis of MS, including Clinically Isolated Syndrome (CIS)
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Net promoter score based on satisfaction questionnaires
Net promoter score based on satisfaction questionnaires conducted with patients to probe about experience interfacing the MSPT
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 2 years
Plan to share: No
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This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern