NCT04423809

Brief Summary

Family support is a positive predictor for psychiatric patients. For example, since the 1980s, it has been shown that family psychoeducation improves patient adherence to care and statistically decreases patient relapse and hospitalization rates by half, resulting in lower care costs. Yet, the stress of hospitalizing a patient, seeing the feelings of shame or guilt of caregiver and the impact on their quality of life are rarely taken into account by caregivers during the first weeks hospitalization in a patient's psychiatry. Barrelet emphasizes the importance of organizing the meeting in the first hours of hospitalization with the family in order to strengthen the alliance, to improve communication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

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

Study Start

First participant enrolled

June 10, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3 years

First QC Date

June 5, 2020

Last Update Submit

June 5, 2020

Conditions

Keywords

Psychiatry Nurse Burden Caregiver

Outcome Measures

Primary Outcomes (1)

  • Center for Epidemiologic Studies-Depression scale

    is a simple tool for assessing depressive symptomatology for the general population

    at patient admission

Secondary Outcomes (3)

  • Zarit burden inventory

    at patient admission

  • Short form 36

    at patient admission

  • Semi-directional interview

    At patient admission

Study Arms (1)

caregivers of adult patients hospitalized in psychiatry

a face-to-face interview with a nurse and self-assessment scales.

Other: clinical assessment

Interventions

assessment of caregivers suffering when a family member is hospitalized

Also known as: Interview
caregivers of adult patients hospitalized in psychiatry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

caregiver of patient hospitalised in psychiatry

You may qualify if:

  • Family members or relatives
  • Over 18 years
  • Having a relative
  • First hospitalized in psychiatry or hospitalized in psychiatry within 5 years
  • Over 18 years of age
  • Psychotic episode
  • Having been informed of their participation in this study
  • In regular contact with the patient prior to hospitalization, at least 4 hours per week.
  • French language
  • Signed written informed consent.

You may not qualify if:

  • Psychiatric pathology of another family member than the hospitalized.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de recherche clinique

Neuilly-sur-Marne, Île-de-France Region, 93330, France

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of the clinical research unit

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 9, 2020

Study Start

June 10, 2015

Primary Completion

June 8, 2018

Study Completion

March 27, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations