- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03427190
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
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
Interventional
Enrollment (Actual)
259
Phase
- 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
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Cayenne, French Guiana, 97306
- CH de Cayenne
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Saint-Laurent du Maroni, French Guiana, 97393
- CH Ouest Guyanais
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Les Abymes, Guadeloupe, 97189
- CHU de Pointe à Pitre
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Saint-claude, Guadeloupe, 97120
- CH de Monteran
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Fort-de-France, Martinique, 97261
- CHU Martinique
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Saint-Benoit, Réunion, 97470
- Etablissement Psychiatrique de Santé Mentale
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Saint-Paul, Réunion, 97863
- Centre d'Accueil Psychiatrique Ouest-Centre
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Saint-Pierre, Réunion, 97448
- Centre d'Accueil d'Urgences Médico-Psychologique
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Saint-denis, Réunion, 97405
- Centre d'Accueil Psychiatrique Nord
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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
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 |
Intervention / Treatment |
---|---|
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.
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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.
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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.
|
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Existence of a suicide
Time Frame: 6 months
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Reiteration of suicidal attempt after hospital discharge
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6 months
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Existence of a suicide
Time Frame: 13 months
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Reiteration of suicidal attempt after hospital discharge
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13 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of suicide attempts
Time Frame: 6 and 13 months after hospital discharge
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To know total number of suicide
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6 and 13 months after hospital discharge
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Number of deaths by suicide
Time Frame: 6 and 13 months after hospital discharge
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To know number of deaths by suicide
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6 and 13 months after hospital discharge
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Scores at the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 6 and 13 months after hospital discharge
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Pass the scale HADS
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6 and 13 months after hospital discharge
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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
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Pass the scale Columbia
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6 and 13 months after hospital discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- 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.
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)
October 9, 2017
Primary Completion (ACTUAL)
August 8, 2019
Study Completion (ACTUAL)
October 16, 2020
Study Registration Dates
First Submitted
January 30, 2017
First Submitted That Met QC Criteria
February 2, 2018
First Posted (ACTUAL)
February 9, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 28, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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