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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02814487

Acronym

DAM

Enrollment

Registered

2016-06-27

Start date

2015-12-31

Completion date

2016-09-30

Last updated

2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

DAM, multiple sclerosis, MSFC, application, smartphone

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
correlation between the MSFC score and the DAM score	At Day 0

Secondary

Measure	Time frame
correlation between the DAM score	At Day 0 and Day 30
correlation between the the MSFC and the DAM score	At Day 90

Outcome results