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

Multiple Sclerosis Clinical Trial

— DAM  

Official title:

A Pilot Validation Study Comparing "DAM" a Smartphone Application With the Composite MSFC Score Intra-individually Among Multiple Sclerosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814487
• Other study ID #: P003
• Status: Completed
• Phase: N/A
• First received: June 22, 2016
• Last updated: September 9, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: Ad scientiam
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ad scientiam	Roche Pharma AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between the MSFC score and the DAM score		At Day 0	No
Secondary	correlation between the DAM score		At Day 0 and Day 30	No
Secondary	correlation between the DAM score		At Day 60 and Day 90	No
Secondary	correlation between the the MSFC and the DAM score		At Day 90	No