Suicide, AttemptedEVAREST3NCT05966077
Impact of Sending an Sms on the Rate of Telephone Responses of Subjects Contacted 3 Months After the Suicidal Act
A study testing IMPACT OF SENDING AN SMS in people with Suicide, Attempted, run by Centre Psychothérapique de Nancy.
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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- IMPACT OF SENDING AN SMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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:
Read more
- 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.
- Conditions
- Suicide, Attempted
- Being tested
- IMPACT OF SENDING AN SMS
- Keywords
- suicide attempt prevention standby device
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACT OF SENDING AN SMSOther
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
| Study group | Role | What they receive |
|---|---|---|
| SMS | Experimental | Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
SMS delivery status:
issued/not issued
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trials
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- Xavier SIPP, Mr., Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966077
- Sponsor's protocol ID
- 2022-A01404-39
- Other IDs
- RIPH-2022-02
- Acronym
- EVAREST3
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05966077
- Acronym / sponsor ID
- EVAREST3 / 2022-A01404-39
- Conditions
- Suicide, Attempted
- Keywords
- suicide attempt prevention standby device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trials
| Arm | Type | Receives |
|---|---|---|
| SMS | Experimental | Other: IMPACT OF SENDING AN SMSSending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system |
| Without SMS | No intervention | –without Sending an SMS 48 hours before the 3-month evaluation call planned as part of the VigilanS Lorraine system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Subject having received information relating to the progress of the EVAREST 3 study and having given their consent to participate
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPACT OF SENDING AN SMSEach 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 | Other | SMS |
Primary outcome
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.
2 secondary outcomes
SMS delivery status:
Time frame: 3 months
Satisfaction survey
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier SIPP, Mr. principal investigator
Centre Psychothérapique de Nancy
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT OF SENDING AN SMS in people with Suicide, Attempted, run by Centre Psychothérapique de Nancy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier SIPP (03.83.85.16.58 ext. 0033, xavier.sipp@cpn-laxou.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of successful calls during the 3 month evaluation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.