NCT05966077

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 8, 2024

Status Verified

September 1, 2023

Enrollment Period

Same day

First QC Date

July 21, 2023

Last Update Submit

February 7, 2024

Conditions

Keywords

suicide attempt prevention standby device

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (2)

  • SMS delivery status:

    3 months

  • Satisfaction survey

    3 months

Study Arms (2)

SMS

EXPERIMENTAL

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

Other: IMPACT OF SENDING AN SMS

Without SMS

NO INTERVENTION

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

Interventions

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

SMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having made a suicide attempt (first-time suicide or not)
  • Hosted at the Central Hospital of Nancy
  • Included in the "VigilanS Lorraine" monitoring system
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Xavier SIPP, Mr.

    Centre Psychothérapique de Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naoual MELLOUKI BENDIM'RED, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trials
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2023

First Posted

July 28, 2023

Study Start

June 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

February 8, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share