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

• ClinicalTrials.gov Identifier: NCT05966077
• Recruitment Status: Not yet recruiting
• First Posted: July 28, 2023
• Last Update Posted: February 8, 2024
• Sponsor: Centre Psychothérapique de Nancy
• Collaborator: Groupement Interrégional de Recherche Clinique et d'Innovation
• Information provided by (Responsible Party): Centre Psychothérapique de Nancy

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.

Condition or disease	Intervention/treatment	Phase
Suicide, Attempted	Other: IMPACT OF SENDING AN SMS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trials
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Estimated Study Start Date: June 1, 2024
• Estimated Primary Completion Date: June 1, 2024
• Estimated Study Completion Date: June 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Percentage of successful calls during the 3 month evaluation [ Time Frame: 3 months ]
   . A call is considered unsuccessful after 3 call attempts at 3 different times over 3 consecutive working days.

Secondary Outcome Measures :

1. SMS delivery status: [ Time Frame: 3 months ]
   issued/not issued
2. Satisfaction survey [ Time Frame: 3 months ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Xavier SIPP; 03.83.85.16.58 ext 0033; xavier.sipp@cpn-laxou.com

Contact: Naoual MELLOUKI BENDIM'RED, PhD; 0383925267 ext 0033; unic@cpn-laxou.com

Sponsors and Collaborators

Centre Psychothérapique de Nancy

Groupement Interrégional de Recherche Clinique et d'Innovation

Investigators

• Principal Investigator: Xavier SIPP, Mr.; Centre Psychothérapique de Nancy

More Information

• Responsible Party: Centre Psychothérapique de Nancy
• ClinicalTrials.gov Identifier: NCT05966077
• Other Study ID Numbers: 2022-A01404-39; RIPH-2022-02 ( Other Identifier: Centre Psychothérapique de Nancy )
• First Posted: July 28, 2023
• Last Update Posted: February 8, 2024
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Psychothérapique de Nancy:

suicide attempt prevention standby device

Additional relevant MeSH terms:

Suicide; Suicide, Attempted; Self-Injurious Behavior; Behavioral Symptoms