Suicide Prevention Algorithm in the French Overseas Territories (APSOM)

January 26, 2021 updated by: University Hospital Center of Martinique

Assessment of Preventive Efficacy of an Algorithm Taking Place After Suicide Attempts Among Attempters Admitted to Hospital in the French Overseas Territories

In France, suicide behaviours are a major public health concern that triggered the creation in 2013 of a National Observatory of Suicide. In continental France, the "Algos" protocol was found to be effective for the prevention of suicide attempts reiterations. This protocol is based on a procedure that keeps telephone and postal contacts with the suicide attempter and allows, via an algorithm, to assess the risk of suicide attempt recurrence, in order to intervene if necessary. Nevertheless, Algos does not involve primary care health practitioners, who could add a substantial additional efficacy, especially if they intervene downstream and in supplement to Algos. In addition, this kind of protocol has never been evaluated in the French overseas territories.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Since (1) Algos was never implemented in the French overseas departments (FOD) and does not involve primary care practitioners (PCP), (2) the additional effect of PCP involvement over and beyond Algos alone in unknown, and (3) little research on suicide behaviours has been conducted in the FOD, this proposal has the following main aim: to assess the effectiveness and the efficacy of the intervention, in supplement and downstream to Algos, of a healthcare professional, on the recurrence of suicide attempts in the FOD; the healthcare professional will be the patient's general practitioner, whenever possible.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
259

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • French Guiana
      • Cayenne, French Guiana, 97306
        • CH de Cayenne
      • Saint-Laurent du Maroni, French Guiana, 97393
        • CH Ouest Guyanais
  • Guadeloupe
      • Les Abymes, Guadeloupe, 97189
        • CHU de Pointe à Pitre
      • Saint-claude, Guadeloupe, 97120
        • CH de Monteran
  • Martinique
      • Fort-de-France, Martinique, 97261
        • CHU Martinique
  • Réunion
      • Saint-Benoit, Réunion, 97470
        • Etablissement Psychiatrique de Santé Mentale
      • Saint-Paul, Réunion, 97863
        • Centre d'Accueil Psychiatrique Ouest-Centre
      • Saint-Pierre, Réunion, 97448
        • Centre d'Accueil d'Urgences Médico-Psychologique
      • Saint-denis, Réunion, 97405
        • Centre d'Accueil Psychiatrique Nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Man or woman over 16 years of age
  • Leaving the hospital within 15 days of the suicide attempt
  • Giving (him/herself or his/her legal representative)an oral consent to participate in the study
  • Having healthcare insurance
  • Reachable by phone, with possibility of confidential conversation, and by mail
  • Resident of Guadeloupe, French Guyana, Martinique, or Reunion Island
  • Able to understand and speak French

Exclusion Criteria:

  • Homeless person
  • Disabled adult, person under judicial/court protection, legally incompetent adult
  • Participant unable to understand the study protocol, its risks and side effects, or declining to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Control
Phone contact with patient will be made by a professional psychologist within 21 days of hospital discharge. If contact cannot be made after 9 attempts, post-cards will be sent monthly at M2, M3, M4 and M5, asking the participant to establish contact with the designated psychologist. The phone call will determine whether or not the participant is in a state of suicidal crisis. If yes, steps will be taken to attend the crisis within 24 hours.
Other: APSOM vs Control
In complement to actions described in the control arm, the patient's general practitioner (GP) and the patient him/herself will be contacted within 21 days of hospital discharge in order to organize an appointment between them two; this consultation is expected to take place between day 22 and day 45 after hospital discharge. If the patient does not have a GP, a health-care professional (HCP) will be provided. .GP (or HCP) will also be contacted at 6 and 13 months.
OTHER: APSOM
In complement to actions described in the control arm, the patient's general practitioner (GP) and the patient him/herself will be contacted within 21 days of hospital discharge in order to organize an appointment between them two; this consultation is expected to take place between day 22 and day 45 after hospital discharge. If the patient does not have a GP, a health-care professional (HCP) will be provided. .GP (or HCP) will also be contacted at 6 and 13 months.
Other: APSOM vs Control
In complement to actions described in the control arm, the patient's general practitioner (GP) and the patient him/herself will be contacted within 21 days of hospital discharge in order to organize an appointment between them two; this consultation is expected to take place between day 22 and day 45 after hospital discharge. If the patient does not have a GP, a health-care professional (HCP) will be provided. .GP (or HCP) will also be contacted at 6 and 13 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Existence of a suicide
Time Frame: 6 months
Reiteration of suicidal attempt after hospital discharge
6 months
Existence of a suicide
Time Frame: 13 months
Reiteration of suicidal attempt after hospital discharge
13 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of suicide attempts
Time Frame: 6 and 13 months after hospital discharge
To know total number of suicide
6 and 13 months after hospital discharge
Number of deaths by suicide
Time Frame: 6 and 13 months after hospital discharge
To know number of deaths by suicide
6 and 13 months after hospital discharge
Scores at the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 6 and 13 months after hospital discharge
Pass the scale HADS
6 and 13 months after hospital discharge
Assessment of suicidal risk by the Sad Persons Scale and the Columbia Suicide Severity Rating Scale (C-SSRS).
Time Frame: 6 and 13 months after hospital discharge
Pass the scale Columbia
6 and 13 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Center of Martinique

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre Hospitalier de Cayenne
Centre Hospitalier Universitaire de Pointe-a-Pitre
Centre Hospitalier de Monteran, Guadeloupe
Centre Hospitalier de Ouest Guyanais Franck Joly
Centre d Accueil Psychiatrique Ouest-Centre, La Réunion
Centre d Accueil d Urgences Médico Psychologique, La Réunion
Centre d Accueil Psychiatrique Nord, La Réunion
Etablissement Publique de Santé Mentale de la Réunion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JEHEL Louis, MD-PhD, CHU de Martinique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15/B/04

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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