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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03043040
Other study ID # 2017AG01
Secondary ID
Status Completed
Phase N/A
First received January 31, 2017
Last updated April 6, 2018
Start date July 1, 2014
Est. completion date March 31, 2017

Study information

Verified date April 2018
Source Osakidetza
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter controlled intervention study that aims to assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in adults discharged from general hospitals after a suicide attempt.

The hypothesis is that the implementation of this program is associated with reduced rates of suicide reattempts in these patients and also with delayed reattempts in them.


Description:

Justification: Suicide is a global public health concern and is the leading cause of avoidable death in the Basque Country (Spain). The use of telemedicine techniques applied to high risk patients has shown to be useful in the prevention of suicide and suicidal behavior.

Objectives: To assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in patients who recently attempted suicide.

Design: This is a multicenter, prospective intervention study, non-randomized and with control group.

Method: A sample of adults discharged from 2 general hospitals after a suicide attempt are enrolled in a telephone follow-up program which is added to their usual treatment (TAU). The program consists of 5 short calls made by nurses during 6 months. The calls are intended to: 1) Assess the risk of suicide in that moment, 2) Improve patient's adherence to treatments, and 3) Provide general psychoeducation guidelines. The control group is composed of patients discharged from a third general hospital after a suicide attempt. These receive TAU but are not enrolled in the telephone follow-up.

Evaluation: All patients are followed during 12 months. Main outcome measures include the percentage of patients that make a second attempt and the average time to reattempt.

Patients sign and informed consent.


Recruitment information / eligibility

Status Completed
Enrollment 651
Est. completion date March 31, 2017
Est. primary completion date March 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients discharged from a General Hospital after a suicide attempt and who live in the same health sector as the hospital.

- The suicide attempt must have been made within 24 hours prior to the appointment in the Emergency Service.

Exclusion Criteria:

- Patient with severe cognitive difficulties and in general any self-injury in which the patient does not understand the meaning or potential consequences of such behavior.

- Patients in which a regular telephone contact is not possible.

- Patients in which the psychiatrist who evaluates the case deems inappropriate their inclusion.

- Patients who remain hospitalized 6 months after the attempt.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Telephone follow up
Already described in previous page
Treatment as usual
Already described in previous page

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Osakidetza Eusko Jaurlaritza

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants in each group that make a second attempt (Included in the title) 0-12 months
Secondary Average number of days from the first attempt to the second, in each group (Included in the title) 0-12 months
Secondary Mean number of reattempts in each group (Included in the title) 0-12 months
Secondary Percentage of participants in each group requiring hospitalization after the suicide attempt (Included in the title) 0-12 months
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