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OpenTrials
Completed

NCT Number: NCT02814487

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. correlation between the MSFC score and the DAM score

    Time frame: At Day 0

Secondary outcomes

  1. correlation between the DAM score

    Time frame: At Day 0 and Day 30

  2. correlation between the DAM score

    Time frame: At Day 60 and Day 90

  3. correlation between the the MSFC and the DAM score

    Time frame: At Day 90

Sponsors and collaborators

Lead sponsor

Ad scientiam

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

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

Acronym: DAM

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 27, 2016
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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