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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01176929
Other study ID # OST08017
Secondary ID
Status Completed
Phase N/A
First received August 5, 2010
Last updated April 10, 2013
Start date October 2009
Est. completion date November 2012

Study information

Verified date April 2013
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

The prevention of recurrent suicidal about people who have made a suicide attempt is a major strand in the prevention of suicide. It is estimated that 10-15 % of people who made a suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at one year. Most people who made a suicide attempt receive ambulatory monitoring. On this population, there is a low adherence to care.

The main objective of the study is to test the effectiveness of a prevention program of recurrent suicidal acts for people who made a suicide attempt.

The secondary objectives of this study are the assessment of adherence to care; the identification of sub - populations benefiting most from this program; the evaluation of the possible generalization level of the program (eligibles persons rate) and its feasibility level.


Description:

This is a randomized, controlled and prospective trial comparing an experimental group (usual treatment + interventions) to a control group (usual treatment only). All participants are evaluated after one year of monitoring. The search duration is 2 years (one inclusion year and one year of follow-up). It is planned to include 330 patients, 165 patients in each group.

The program (experimental group) includes three interventions:

- A series of three telephone calls ( the second week , one month and three months after discharge from hospital )

- A systematic telephone contact with the referring physician

- A telephone helpline for people who made a suicide attempt and referring physicians.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults = 18 years.

- Patients admitted to the emergency department for a suicide attempt.

- Patients referred to outpatient care.

- Patients who have given their written consent.

Exclusion Criteria:

- Patients not affiliated to social security.

- Patients do not have the faculties needed to be evaluated (cognitive or delusional disorder).

- Patients hospitalized for longer than 72 hours.

- Patients can not be recalled by phone (no phone, homeless, incarcerated)

- Patients who do not speak French.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Usual treatment and Prevention program
Prevention program of recurrent suicidal acts includes three interventions: A series of three telephone calls ( the second week , one month and three months after discharge from hospital ) A systematic telephone contact with the referring physician A telephone helpline for people who made a suicide attempt and referring physicians.
Usual Treatment
Usual Treatment

Locations

Country Name City State
France Assistance Publique - Hôpitaux de Paris : BICETRE Hospital Le Kremlin Bicetre

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary suicidal act frequency The primary endpoint is the occurrence of a suicidal act (occurrence or not). The suicidal act includes suicide and suicide attempt. 12 months No
Secondary suicide attempts frequency Number of occurrence of suicide attempts. 12 months No
Secondary Adherence to health care Adherence to health care:
Defined by:
The Initialization of outpatient care proposed by the suicidology's team at the initial interview or during telephone contacts.
The number of consultations within 3 months after the first appointment with the referring doctor.
12 months No
Secondary Number of eligibles persons Number of eligibles persons:
Number of people (among all people admitted to the emergency department fo a suicide attempt) meeting the criteria of selection.
12 months No
Secondary Number of participants responding to telephone calls Number of participants responding to telephone calls:
We consider the failure to call after three unsuccessful telephone calls to three different days.
12 months No
Secondary Number of people lost sight of Number of people lost sight of:
A person is considered lost sight if no information can be obtained after contact with the person himself, a third (nearest designated), a doctor (general practitioner and / or psychiatrist) and the nearest emergency department.
12 months Yes
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