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Impact of Sending an Sms on the Rate of Telephone Responses of Subjects Contacted 3 Months After the Suicidal Act (EVAREST3)

Primary Purpose

Suicide, Attempted

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IMPACT OF SENDING AN SMS
Sponsored by
Centre Psychothérapique de Nancy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide, Attempted focused on measuring suicide attempt prevention standby device

Eligibility Criteria

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

Inclusion Criteria: Having made a suicide attempt (first-time suicide or not) Hosted at the Central Hospital of Nancy Included in the "VigilanS Lorraine" monitoring system Not presenting criteria for non-inclusion in the "VigilanS Lorraine" system, namely: Guardianship Held Dementia Not speaking French Subject having received information relating to the progress of the EVAREST 3 study and having given their consent to participate Subject affiliated or entitled to a social security scheme Exclusion Criteria: Subject without mobile phone Participation in another interventional study on the prevention of suicidal recidivism Subject under curatorship who was not assisted by his curator to give his consent to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SMS

    Without SMS

    Arm Description

    Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system

    without Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system

    Outcomes

    Primary Outcome Measures

    Percentage of successful calls during the 3 month evaluation
    . A call is considered unsuccessful after 3 call attempts at 3 different times over 3 consecutive working days.

    Secondary Outcome Measures

    SMS delivery status:
    issued/not issued
    Satisfaction survey
    subjective experience of the subject having benefited from the sending of the SMS in relation to the intervention, the delay between the sending of the SMS and the telephone call

    Full Information

    First Posted
    July 21, 2023
    Last Updated
    September 1, 2023
    Sponsor
    Centre Psychothérapique de Nancy
    Collaborators
    Groupement Interrégional de Recherche Clinique et d'Innovation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05966077
    Brief Title
    Impact of Sending an Sms on the Rate of Telephone Responses of Subjects Contacted 3 Months After the Suicidal Act
    Acronym
    EVAREST3
    Official Title
    Impact of Sending an Sms in the "Vigilans Lorraine" Monitoring System on the Rate of Telephone Responses of Subjects Contacted 3 Months After a Passage to the Suicidal Act
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Psychothérapique de Nancy
    Collaborators
    Groupement Interrégional de Recherche Clinique et d'Innovation

    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 objective of this controlled, randomized, monocentric study is to compare the response rate of the call at 3 months of the groups with or without short message service (SMS) 48 hours before, for the subjects having benefited from the device "VigilanS Lorraine". The secondary objectives will be to appreciate the satisfaction of the subjects towards the sending of the SMS as well as to compare the delay of suicidal recidivism according to whether the subjects answered or not to the call of evaluation at 3 months of the passage to the act The main question it aims to answer is: What impact, on the rate of successful calls, could sending a text message 48 hours before the 3-month evaluation phone call have on subjects benefiting from the VigilanS device? The participants will be divided into 2 groups: 1st group: SMS sent 48 hours before the 3-month evaluation call planned in the framework of the "VigilanS Lorraine" program. 2nd group (control): evaluation call at 3 months planned within the framework of the "VigilanS Lorraine" system, not preceded by an SMS 48 hours before. The desired effect was an increase in the percentage of successful calls at 3 months, allowing for possible evaluations at 3 months in order to identify, evaluate and accompany subjects still in a suicidal crisis and thus avoid a recurrence of the act and thus a suicide.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide, Attempted
    Keywords
    suicide attempt prevention standby device

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trials
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SMS
    Arm Type
    Experimental
    Arm Description
    Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system
    Arm Title
    Without SMS
    Arm Type
    No Intervention
    Arm Description
    without Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system
    Intervention Type
    Other
    Intervention Name(s)
    IMPACT OF SENDING AN SMS
    Intervention Description
    Each subject of the experimental group will receive, in addition to the usual procedure of the VigilanS Lorraine device, an SMS 48 hours before the telephone call for evaluation at 3 months, warning him of this call. The time of this SMS has been set at 1:00 p.m. for all the people included in this group. At the end of this evaluation call, the caller will pass a satisfaction questionnaire to the subject in relation to the sending of the SMS
    Primary Outcome Measure Information:
    Title
    Percentage of successful calls during the 3 month evaluation
    Description
    . A call is considered unsuccessful after 3 call attempts at 3 different times over 3 consecutive working days.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    SMS delivery status:
    Description
    issued/not issued
    Time Frame
    3 months
    Title
    Satisfaction survey
    Description
    subjective experience of the subject having benefited from the sending of the SMS in relation to the intervention, the delay between the sending of the SMS and the telephone call
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having made a suicide attempt (first-time suicide or not) Hosted at the Central Hospital of Nancy Included in the "VigilanS Lorraine" monitoring system Not presenting criteria for non-inclusion in the "VigilanS Lorraine" system, namely: Guardianship Held Dementia Not speaking French Subject having received information relating to the progress of the EVAREST 3 study and having given their consent to participate Subject affiliated or entitled to a social security scheme Exclusion Criteria: Subject without mobile phone Participation in another interventional study on the prevention of suicidal recidivism Subject under curatorship who was not assisted by his curator to give his consent to participate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xavier SIPP
    Phone
    03.83.85.16.58
    Ext
    0033
    Email
    xavier.sipp@cpn-laxou.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Naoual MELLOUKI BENDIM'RED, PhD
    Phone
    0383925267
    Ext
    0033
    Email
    unic@cpn-laxou.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xavier SIPP, Mr.
    Organizational Affiliation
    Centre Psychothérapique de Nancy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Impact of Sending an Sms on the Rate of Telephone Responses of Subjects Contacted 3 Months After the Suicidal Act

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