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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 (VIGIP-SEP2)

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nurse training of the patient
neurologist accompaniement
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    nurse training of the patient

    simple information of the patient by neurologist

    Arm Description

    Outcomes

    Primary Outcome Measures

    number of patients who reported at least one ADR

    Secondary Outcome Measures

    Full Information

    First Posted
    October 3, 2019
    Last Updated
    October 3, 2019
    Sponsor
    University Hospital, Caen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04116424
    Brief Title
    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
    Acronym
    VIGIP-SEP2
    Official Title
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    April 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Caen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    nurse training of the patient
    Arm Type
    Experimental
    Arm Title
    simple information of the patient by neurologist
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    nurse training of the patient
    Intervention Description
    visit + telephone follow-up
    Intervention Type
    Other
    Intervention Name(s)
    neurologist accompaniement
    Intervention Description
    presentation during consultation by neurologist
    Primary Outcome Measure Information:
    Title
    number of patients who reported at least one ADR
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    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

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