NCT02721316

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

March 8, 2016

Last Update Submit

February 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Day 3rd, 6rd day, 3 weeks, 6 weeks and 12 week after emergency exit

Secondary Outcomes (1)

  • 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

    Day 3rd, 6rd day, 3 weeks, 6 weeks and 12 week after emergency exit

Study Arms (2)

Supported with intensive nursing follow

EXPERIMENTAL

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

usual care

NO INTERVENTION

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

Interventions

Intensive nursing follow post - hospitalization

Supported with intensive nursing follow

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mood DisordersAdjustment Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Mental DisordersTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Grégory Mykolow

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 29, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

October 1, 2021

Last Updated

February 9, 2023

Record last verified: 2022-02