search
Back to results

Prevention of Suicidal Behaviour With Telemedicine Techniques

Primary Purpose

Suicide, Attempted

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telephone follow up
Treatment as usual
Sponsored by
Osakidetza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide, Attempted focused on measuring suicide, attempted, prevention, telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Telephone follow up

    Control

    Arm Description

    Patients discharged from hospital A and B after a suicide attempt receive a protocolized telephone follow which is added to their usual treatment (TAU). Calls are made by nurses at weeks 1,2,4,12 and 24 after the index suicide attempt. TAU: Includes whatever treatment the doctor decides to offer to that patient (psychopharmacology, psychotherapy etc).

    Patients discharged from hospital C after a suicide attempt receive treatment as usual (whatever treatment the doctor decides to offer to that patient: psychopharmacology, psychotherapy etc).

    Outcomes

    Primary Outcome Measures

    Percentage of participants in each group that make a second attempt
    (Included in the title)

    Secondary Outcome Measures

    Average number of days from the first attempt to the second, in each group
    (Included in the title)
    Mean number of reattempts in each group
    (Included in the title)
    Percentage of participants in each group requiring hospitalization after the suicide attempt
    (Included in the title)

    Full Information

    First Posted
    January 31, 2017
    Last Updated
    April 6, 2018
    Sponsor
    Osakidetza
    Collaborators
    Eusko Jaurlaritza
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03043040
    Brief Title
    Prevention of Suicidal Behaviour With Telemedicine Techniques
    Official Title
    Prevention of Suicidal Behaviour in High Risk Patients With Telemedicine Techniques
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2014 (Actual)
    Primary Completion Date
    March 31, 2017 (Actual)
    Study Completion Date
    March 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Osakidetza
    Collaborators
    Eusko Jaurlaritza

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide, Attempted
    Keywords
    suicide, attempted, prevention, telemedicine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a non-randomized non-blinded multicenter intervention study with control group. Patients from hospital A and B are included in the intervention group. Patients from hospital C are included in the control group.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    651 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Telephone follow up
    Arm Type
    Experimental
    Arm Description
    Patients discharged from hospital A and B after a suicide attempt receive a protocolized telephone follow which is added to their usual treatment (TAU). Calls are made by nurses at weeks 1,2,4,12 and 24 after the index suicide attempt. TAU: Includes whatever treatment the doctor decides to offer to that patient (psychopharmacology, psychotherapy etc).
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Patients discharged from hospital C after a suicide attempt receive treatment as usual (whatever treatment the doctor decides to offer to that patient: psychopharmacology, psychotherapy etc).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Telephone follow up
    Intervention Description
    Already described in previous page
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as usual
    Intervention Description
    Already described in previous page
    Primary Outcome Measure Information:
    Title
    Percentage of participants in each group that make a second attempt
    Description
    (Included in the title)
    Time Frame
    0-12 months
    Secondary Outcome Measure Information:
    Title
    Average number of days from the first attempt to the second, in each group
    Description
    (Included in the title)
    Time Frame
    0-12 months
    Title
    Mean number of reattempts in each group
    Description
    (Included in the title)
    Time Frame
    0-12 months
    Title
    Percentage of participants in each group requiring hospitalization after the suicide attempt
    Description
    (Included in the title)
    Time Frame
    0-12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prevention of Suicidal Behaviour With Telemedicine Techniques

    We'll reach out to this number within 24 hrs