The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family Members Clinical Trial
— AFPOfficial title:
Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study
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 |
Verified date | June 2020 |
Source | Centre hospitalier de Ville-Evrard, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Unité de recherche clinique | Neuilly Sur Marne | Île De France |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de Ville-Evrard, France |
France,
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 |