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Outpatient Nurse Monitoring Under the Prevention of Recurrent Suicidal (SIPRéS)

Primary Purpose

Mood Disorder, Reactive Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supported with intensive nursing follow post hospitalization
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mood Disorder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient suffering from a mood disorder (unipolar or bipolar) or reactive depression whose reason for hospitalization in the Psychiatric Emergency Unit Post has attempted suicide

Exclusion Criteria:

  • Patients with bipolar disorder, current episode manic in
  • Patient Hospitalized full-time (for high suicide risk incompatible with an output of emergencies or clinical transfer) within 3-5 days of the TS
  • Patient suffering from a somatic pathology associated with the prognosis is committed in the short term.
  • Patients suffering from a neurodegenerative pathology of dementia or pre-dementia types.
  • Homeless Patient

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Supported with intensive nursing follow

    usual care

    Arm Description

    Supported with intensive nursing follow post hospitalization the team of hospital output of the unit to 12 weeks after discharge. These interviews will be conducted at the hospital, at home or by phone and their pace will be adjusted according to the patient's condition. The expected duration of close outpatient follow-up is of maximum 3 months.

    For control patients, monitoring will be identical to their usual care as part of their pathology.

    Outcomes

    Primary Outcome Measures

    Change the suicidal rate of recurrence between patients with intensive nursing follow post - hospitalization and patients with usual care

    Secondary Outcome Measures

    Change in the number of emergency hospitalization for suicidal crisis without acting out between patients with intensive nursing follow post - hospitalization and patients with usual care

    Full Information

    First Posted
    March 8, 2016
    Last Updated
    February 8, 2023
    Sponsor
    University Hospital, Montpellier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02721316
    Brief Title
    Outpatient Nurse Monitoring Under the Prevention of Recurrent Suicidal
    Acronym
    SIPRéS
    Official Title
    Randomized Study of Ambulatory Monitoring Nurse Under the Prevention of Recurrent Suicidal
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    October 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.
    Detailed Description
    Main objective: To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression. Secondary objectives: Studying during the year following the suicide attempt index, the impact of this device on: The frequency and intensity of suicidal ideation the spontaneous use of emergency care the death rate from suicide and other causes the cumulative duration of hospitalization for suicidal behavior The patient's quality of life the number of patients lost to at the end of search Studying patient compliance with intensive nursing monitoring program. To study the role of the nurse to determine the factors that promote the construction of a therapeutic alliance. Establish a mapping of needs and resources suicidal patient for nursing care in post-emergency.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mood Disorder, Reactive Depression

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    380 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supported with intensive nursing follow
    Arm Type
    Experimental
    Arm Description
    Supported with intensive nursing follow post hospitalization the team of hospital output of the unit to 12 weeks after discharge. These interviews will be conducted at the hospital, at home or by phone and their pace will be adjusted according to the patient's condition. The expected duration of close outpatient follow-up is of maximum 3 months.
    Arm Title
    usual care
    Arm Type
    No Intervention
    Arm Description
    For control patients, monitoring will be identical to their usual care as part of their pathology.
    Intervention Type
    Other
    Intervention Name(s)
    Supported with intensive nursing follow post hospitalization
    Intervention Description
    Intensive nursing follow post - hospitalization
    Primary Outcome Measure Information:
    Title
    Change the suicidal rate of recurrence between patients with intensive nursing follow post - hospitalization and patients with usual care
    Time Frame
    Day 3rd, 6rd day, 3 weeks, 6 weeks and 12 week after emergency exit
    Secondary Outcome Measure Information:
    Title
    Change in the number of emergency hospitalization for suicidal crisis without acting out between patients with intensive nursing follow post - hospitalization and patients with usual care
    Time Frame
    Day 3rd, 6rd day, 3 weeks, 6 weeks and 12 week after emergency exit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient suffering from a mood disorder (unipolar or bipolar) or reactive depression whose reason for hospitalization in the Psychiatric Emergency Unit Post has attempted suicide Exclusion Criteria: Patients with bipolar disorder, current episode manic in Patient Hospitalized full-time (for high suicide risk incompatible with an output of emergencies or clinical transfer) within 3-5 days of the TS Patient suffering from a somatic pathology associated with the prognosis is committed in the short term. Patients suffering from a neurodegenerative pathology of dementia or pre-dementia types. Homeless Patient
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Grégory Mykolow
    Organizational Affiliation
    University Hospital, Montpellier
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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