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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05966077
Other study ID # 2022-A01404-39
Secondary ID RIPH-2022-02
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2025

Study information

Verified date September 2023
Source Centre Psychothérapique de Nancy
Contact Xavier SIPP
Phone 03.83.85.16.58
Email xavier.sipp@cpn-laxou.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date June 1, 2025
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Centre Psychothérapique de Nancy Groupement Interrégional de Recherche Clinique et d'Innovation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 SMS delivery status: issued/not issued 3 months
Secondary 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
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