Clinical trial NCT02814487: MSFC Versus DAM. A Smartphone Application for Multiple Sclerosis Self-assessment.
Official title: A Pilot Validation Study Comparing "DAM" a Smartphone Application With the Composite MSFC Score Intra-individually Among Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: DAM
multiple sclerosis
MSFC
application
smartphone
Lead sponsor: Ad scientiam
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2016-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with multiple sclerosis

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

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)

Primary outcomes:
measure: correlation between the MSFC score and the DAM score
timeFrame: At Day 0
Secondary outcomes:
measure: correlation between the DAM score
timeFrame: At Day 0 and Day 30
measure: correlation between the DAM score
timeFrame: At Day 60 and Day 90
measure: correlation between the the MSFC and the DAM score
timeFrame: At Day 90
Other outcomes:
Locations:
Study officials:
affiliation: Pitié Salpêtrière Hospital, Paris
name: Elisabeth MAILLARD, MD
role: PRINCIPAL_INVESTIGATOR
References: