Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt (OSTA)
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|ClinicalTrials.gov Identifier: NCT01176929|
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : April 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Suicide, Attempted||Other: Usual treatment and Prevention program Other: Usual Treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: Interventional group
Usual treatment + prevention program of recurrent suicidal acts
Other: Usual treatment and Prevention program
Prevention program of recurrent suicidal acts includes three interventions:
Other Name: Prevention program
Active Comparator: Control group
Other: Usual Treatment
- suicidal act frequency [ Time Frame: 12 months ]The primary endpoint is the occurrence of a suicidal act (occurrence or not). The suicidal act includes suicide and suicide attempt.
- suicide attempts frequency [ Time Frame: 12 months ]Number of occurrence of suicide attempts.
- Adherence to health care [ Time Frame: 12 months ]
Adherence to health care:
- 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.
- Number of eligibles persons [ Time Frame: 12 months ]
Number of eligibles persons:
Number of people (among all people admitted to the emergency department fo a suicide attempt) meeting the criteria of selection.
- Number of participants responding to telephone calls [ Time Frame: 12 months ]
Number of participants responding to telephone calls:
We consider the failure to call after three unsuccessful telephone calls to three different days.
- Number of people lost sight of [ Time Frame: 12 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176929
|Assistance Publique - Hôpitaux de Paris : BICETRE Hospital|
|Le Kremlin Bicetre, France, 94275|
|Principal Investigator:||Arnaud MARCHAND, MD||Assistance Publique - Hôpitaux de Paris|