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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03427190
Other study ID # 15/B/04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 9, 2017
Est. completion date October 16, 2020

Study information

Verified date October 2020
Source University Hospital Center of Martinique
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 259
Est. completion date October 16, 2020
Est. primary completion date August 8, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
French Guiana CH de Cayenne Cayenne
French Guiana CH Ouest Guyanais Saint-Laurent du Maroni
Guadeloupe CHU de Pointe à Pitre Les Abymes
Guadeloupe CH de Monteran Saint-claude
Martinique CHU Martinique Fort-de-France
Réunion Etablissement Psychiatrique de Santé Mentale Saint-Benoit
Réunion Centre d'Accueil Psychiatrique Nord Saint-denis
Réunion Centre d'Accueil Psychiatrique Ouest-Centre Saint-Paul
Réunion Centre d'Accueil d'Urgences Médico-Psychologique Saint-Pierre

Sponsors (9)

Lead Sponsor Collaborator
University Hospital Center of Martinique Centre d Accueil d Urgences Médico Psychologique, La Réunion, Centre d Accueil Psychiatrique Nord, La Réunion, Centre d Accueil Psychiatrique Ouest-Centre, La Réunion, Centre Hospitalier de Cayenne, Centre Hospitalier de Monteran, Guadeloupe, Centre Hospitalier de Ouest Guyanais Franck Joly, Centre Hospitalier Universitaire de Pointe-a-Pitre, Etablissement Publique de Santé Mentale de la Réunion

Countries where clinical trial is conducted

French Guiana,  Guadeloupe,  Martinique,  Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary Existence of a suicide Reiteration of suicidal attempt after hospital discharge 6 months
Primary Existence of a suicide Reiteration of suicidal attempt after hospital discharge 13 months
Secondary Number of suicide attempts To know total number of suicide 6 and 13 months after hospital discharge
Secondary Number of deaths by suicide To know number of deaths by suicide 6 and 13 months after hospital discharge
Secondary Scores at the Hospital Anxiety and Depression Scale (HADS) Pass the scale HADS 6 and 13 months after hospital discharge
Secondary Assessment of suicidal risk by the Sad Persons Scale and the Columbia Suicide Severity Rating Scale (C-SSRS). Pass the scale Columbia 6 and 13 months after hospital discharge
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