NCT03984682

Brief Summary

For some patients in department psychiatric, isolation measures are put in place. But the measures is not pleasant for the patient or for the care team. That's why care team are trying to find ways to improve patient care, including asking them how they would like to be treated. One of the solutions is called the Joint Crisis Plan. A Joint Crisis Plan is a personalized procedure for a patient. It describes the attitude, the care, the measures in case of crisis with the patient and his family. Patients indicate their wishes regarding their care. However, there is no real scientific proof of the effectiveness of this Joint Crisis Plan, especially to reduce isolation measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2024

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

3.4 years

First QC Date

June 11, 2019

Last Update Submit

April 11, 2024

Conditions

Mental Disorders

Keywords

Joint Crisis PlanInternalized Stigma of Mental Illness (ISMI)Isolationphysical restraintPsychiatry

Outcome Measures

Primary Outcomes (1)

  • Duration of isolation

    Measured in hours.

    Months: 12

Secondary Outcomes (9)

  • Perception of constraint

    Months: 12

  • Number of hospitalizations

    Months: 12

  • Number of isolation

    Months: 12

  • Number of physical restraints

    Months: 12

  • Duration of physical restraint

    Months: 12

  • +4 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients will benefit from regular care + Joint Crisis Plan

Procedure: Joint Crisis Plan

Control group

NO INTERVENTION

Patients will benefit from regular care

Interventions

Joint Crisis PlanPROCEDURE

A Joint Crisis Plan will be drafted with the patient and a nurse

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Patients \>18 years
  • Followed by nurses of a mobile team of psychiatry sector Saint Etienne
  • Social security affiliation
  • Signed informed consent

You may not qualify if:

  • Patient having already had a Joint Crisis Plan for less than 6 months.
  • Patient does not speak French
  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Yvonne QUENUM, Coordinating nurse

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2019

First Posted

June 13, 2019

Study Start

November 21, 2019

Primary Completion

March 28, 2023

Study Completion

April 4, 2024

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)