MSFC Versus DAM. A Smartphone Application for Multiple Sclerosis Self-assessment.

NCT ID: NCT02814487

Last Updated: 2016-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-09-30

Brief Summary

Multiple Sclerosis Functional Composite score (MSFC) is one of the gold standard for multiple sclerosis (MS) patient clinical evaluation. However, its practical implementation is not always optimal as it can prove to be very time consuming. Moreover, it often constrains the range of tests used and is not a particularly good marker for patient real life disability status.

A mobile application called Digital Self-Assessment for Multiple Sclerosis (DAM) was developed in order to replicate each of MSFC tests available in order to assess MS progression in the patient environment.

Detailed Description

Patients are selected during a consultation at the Neurology department of the Pitié-Salpêtrière Hospital (France). Each patient is given access to DAM on their own or a provided iPhone. During the enrolment visit, patients have to complete a MSFC and DAM evaluation (V0). Through a push-notification on their phone, patients are reminded to perform two DAM evaluations at home at days 30 (V1) and 60 (V2). At day 90 (V3), they have to come back to hospital for a second MSFC and DAM evaluation

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with an established diagnosis of Multiple sclerosis according to the MacDonald criterias whatever the progression stage, that are monitored by Dr. Maillart as part of her consultation at the Neurology department of the Pitié-Salpêtrière Hospital.
• Patients with an iPhone (at iOS 8 or higher).
• Patients age ≥18 years.
• Patients with an initial score of EDSS between 0 to 6.5
• No attack since at least 1 month
• Last Solumedrol injection at least 1 month ago

Exclusion Criteria

• Patients who are not capable of using a smartphone application.
• Patients who do not have the capacity to give their consent.
• Patients who do not speak French
• Patients who are bedridden or with a daily activity of less than 2 hours per day
• Patients with acute asthenia
• Patients experiencing an attack once enrolled in the study (will be considered as dropouts)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Ad scientiam

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth MAILLARD, MD

Role: PRINCIPAL_INVESTIGATOR

Pitié Salpêtrière Hospital, Paris

Other Identifiers

P003

Identifier Type: -

Identifier Source: org_study_id