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

NCT02814487 | Completed

• 1 other identifier: P003
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

DAM; multiple sclerosis; MSFC; application; smartphone

Outcome Measures

Primary Outcomes (1)

• correlation between the MSFC score and the DAM score

  At Day 0

Secondary Outcomes (3)

• correlation between the DAM score

  At Day 0 and Day 30

• correlation between the DAM score

  At Day 60 and Day 90

• correlation between the the MSFC and the DAM score

  At Day 90

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with multiple sclerosis

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ad scientiam: lead
• Roche Pharma AG: collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Elisabeth MAILLARD, MD

  Pitié Salpêtrière Hospital, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 27, 2016
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share