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

February 8, 2023 updated by: University Hospital, Montpellier

Randomized Study of Ambulatory Monitoring Nurse Under the Prevention of Recurrent Suicidal

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Supported with intensive nursing follow
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.
Other: Supported with intensive nursing follow post hospitalization
Intensive nursing follow post - hospitalization
NO_INTERVENTION: usual care
For control patients, monitoring will be identical to their usual care as part of their pathology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 3rd, 6rd day, 3 weeks, 6 weeks and 12 week after emergency exit

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 3rd, 6rd day, 3 weeks, 6 weeks and 12 week after emergency exit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Grégory Mykolow, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

October 1, 2021

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (ESTIMATE)

March 29, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF9533

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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