- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04423809
Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study (AFP)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Île De France
-
Neuilly Sur Marne, Île De France, France, 93330
- Unite de Recherche Clinique
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
caregivers of adult patients hospitalized in psychiatry
a face-to-face interview with a nurse and self-assessment scales.
|
assessment of caregivers suffering when a family member is hospitalized
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Center for Epidemiologic Studies-Depression scale
Time Frame: at patient admission
|
is a simple tool for assessing depressive symptomatology for the general population
|
at patient admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Zarit burden inventory
Time Frame: at patient admission
|
to assess burden
|
at patient admission
|
|
Short form 36
Time Frame: at patient admission
|
To assess quality of life
|
at patient admission
|
|
Semi-directional interview
Time Frame: At patient admission
|
It consists of five items: subjective feeling, quality of life, social life, mood of the caregiver.
|
At patient admission
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A01499-38
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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