NCT03510039

Brief Summary

In a context of first hospitalization under the constraint of a relative in psychiatric emergencies:

  • effect of an early intervention and a 6-month nursing follow-up on the anxious experience of third party persons
  • effect of nursing support on family dynamics, on the durability of outpatient care and adherence

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable anxiety

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

March 9, 2018

Last Update Submit

November 9, 2020

Conditions

Anxiety

Keywords

Involuntary commitment hospitalizationclose relative

Outcome Measures

Primary Outcomes (1)

  • Effect of early nursing intervention in the short term on the experience of the close relative

    Effect of early nursing intervention in the short term on the experience of the close relative compared to current support Measured by the evolution between D0 and D7 (first follow-up call telephone) with the AMDP-AT anxiety scale The AMDP system is a clinical measure of psychopathology. The Association de Methodology and Documentation in Psychiatry has developed this system of standardized quantification of psychopathology This is a synthetic version of 17 anxiety items (with a score included between 0 and 68), which is therefore a shorter scale than the full AMDP scale The AMDP-AT is particularly adapted to our emergency situation to assess the experience of the close relative, because it takes into account the multiple dimensions at the moment of the immediate anxiety situation

    6 month

Secondary Outcomes (2)

  • Number of visits to the attending physician, consultations at the Psychological health center

    6 months

  • Effect of nurse intervention over the medium term on the experience of the close relative

    6 months

Study Arms (2)

"Before" Group

ACTIVE COMPARATOR

35 Thirds benefiting from the usual care

Other: Usual care

"After" Group

EXPERIMENTAL

Recruit 35 Thirds for the phase phase "After" : Early device / Follow up by nurses

Behavioral: Early device / Follow up

Interventions

Early device / Follow upBEHAVIORAL

Early device: Standardized Nursing Interview (30 minutes) with the Third Party Person Measure and follow the anxiety of the Third Party by rating the AMDP-AT scale, on D0 and D7 Telephone follow-up by nurses: Interviews built and standardized, to M2, M4 and M6 Quantification of the AMDP-AT anxiety scale on each call

"After" Group
Usual careOTHER

Group "Before" : usual care by nurses

"Before" Group

Eligibility Criteria

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

You may qualify if:

  • Being the "Third Party" adult, during the first involuntary commitment procedure of a close relative, in an ASPDT(u) form.
  • Being physically present during the admission, within 24 hours after the arrival of the patient.
  • Accept to be recontacted by phone to J7, M2, M4 and M6
  • Affiliated person or beneficiary of a social security scheme.

You may not qualify if:

  • To be the guardian or any person in charge of legal representation with the patient.
  • Pregnant or lactating woman (the duration of the study may affect the subject's compliance and availability).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Alexandre CASTANET, nurse

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Mono-centric pilot comparative study like " Before /After ". It will be necessary to recruit at first 35 thirds benefiting from the in current load, "Before" phase, then to set up our intervention, and recruit another 35 different thirds for the "After".
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2018

First Posted

April 27, 2018

Study Start

March 15, 2018

Primary Completion

March 15, 2020

Study Completion

September 13, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)