Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04423809
Other study ID # 2014-A01499-38
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 10, 2015
Est. completion date March 27, 2020

Study information

Verified date June 2020
Source Centre hospitalier de Ville-Evrard, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date March 27, 2020
Est. primary completion date June 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

-Psychiatric pathology of another family member than the hospitalized.

Study Design


Related Conditions & MeSH terms

  • Stress, Psychological
  • The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family Members

Intervention

Other:
clinical assessment
assessment of caregivers suffering when a family member is hospitalized

Locations

Country Name City State
France Unité de recherche clinique Neuilly Sur Marne Île De France

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de Ville-Evrard, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center for Epidemiologic Studies-Depression scale is a simple tool for assessing depressive symptomatology for the general population at patient admission
Secondary Zarit burden inventory to assess burden at patient admission
Secondary Short form 36 To assess quality of life at patient admission
Secondary Semi-directional interview It consists of five items: subjective feeling, quality of life, social life, mood of the caregiver. At patient admission