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 (VIGIP-SEP2)

October 3, 2019 updated by: University Hospital, Caen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

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

Description

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

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

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients who reported at least one ADR
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

University Hospital, Caen

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 (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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