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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicide, Attempted
• Intervention / Treatment: Other: IMPACT OF SENDING AN SMS

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naoual MELLOUKI BENDIM'RED, PhD; Phone Number: 0033 0383925267; Email: unic@cpn-laxou.com
• Study Contact Backup: Name: Xavier SIPP; Phone Number: 0033 03.83.85.16.58; Email: xavier.sipp@cpn-laxou.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMS; 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; 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
No Intervention: Without SMS; without Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
SMS delivery status:	issued/not issued	3 months

Collaborators and Investigators

• Sponsor: Centre Psychothérapique de Nancy
• Collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation
• Investigators: Principal Investigator: Xavier SIPP, Mr., Centre Psychothérapique de Nancy

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: suicide attempt prevention standby device
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: 2022-A01404-39; RIPH-2022-02 (Other Identifier: Centre Psychothérapique de Nancy)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No