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

Caen University Hospital

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Other: nurse training of the patient; Other: neurologist accompaniement

Study type: Interventional

Funder types: Other

Identifiers

NCT04116424

19-022

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

nurse training of the patient

Experimental group

Treatment:

Other: nurse training of the patient

simple information of the patient by neurologist

Active Comparator group

Treatment:

Other: neurologist accompaniement