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

September 9, 2016 updated by: Ad scientiam

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

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with multiple sclerosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation between the MSFC score and the DAM score
Time Frame: At Day 0
At Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
correlation between the DAM score
Time Frame: At Day 0 and Day 30
At Day 0 and Day 30
correlation between the DAM score
Time Frame: At Day 60 and Day 90
At Day 60 and Day 90
correlation between the the MSFC and the DAM score
Time Frame: At Day 90
At Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ad scientiam

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Elisabeth MAILLARD, MD, Pitié Salpêtrière Hospital, Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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