VIGIP-SEP2: Evaluation of the Impact of the Training of Patients by a Nurse on the Adverse Drug Reaction Reporting by RRMS Patient Via a Mobile Application: Randomized Real-life Study

Study Overview
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Brief Summary
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The patient's reporting of adverse drug reactions (ADRs) is recognized as being of interest for post-marketing safety monitoring, but is still underdeveloped in France, with an average lower than the European average. A multidisciplinary team of the University Hospital of Caen, composed of neurologists and pharmacovigilants, has been carrying out since autumn 2017 a national study (VIGIP-SEP1) with 24 research centers in France (12 universitary hospitals, 6 general hospitals, and 6 private-practice neurologists) whose main objective was to evaluate the impact of multiple sclerosis (MS) patients' use of a mobile application (App) to report their ADRs. My eReport France® has been developed by the eVedrug company: ADR reports are sent by patients directly to the Regional Pharmacovigilance Centers, after analyze, clinical pharmacologist send it to the National Competent Authority. As part of VIGIP-SEP1, the accompaniment for the use of the App was carried out very simply by neurologists. We designed a randomized controlled trial based on the assumption that a nurse training of the patient, after the initial prescription of an oral MS drug, with a telephone follow-up within 6 months, will increase by 3 times the number of patients who report ADRs compared to a simple information presented by the neurologist. The number of subjects required is 23 subjects per group.

Official Title
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VIGIP-SEP2: Evaluation of the Impact of the Training of Patients by a Nurse on the Adverse Drug Reaction Reporting by RRMS Patient Via a Mobile Application: Randomized Real-life Study

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: nurse training of the patient
* Other: neurologist accompaniement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: more than 18 years multiple sclerosis in initiation with a DMT patient informed and who gave informed consent Exclusion Criteria: patient without mobile or tablet

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nurse training of the patient<br> | Other: nurse training of the patient<br>* visit + telephone follow-up<br>|
| Active Comparator: simple information of the patient by neurologist<br> | Other: neurologist accompaniement<br>* presentation during consultation by neurologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who reported at least one ADR |  | 3 months |