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
About this trial
This is an interventional prevention trial for Mood Disorder
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
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
NCT ID
NCT02721316
First Posted
March 8, 2016
Last Updated
February 8, 2023
Sponsor
University Hospital, Montpellier
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
Learn more about this trial
Outpatient Nurse Monitoring Under the Prevention of Recurrent Suicidal
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