Schizophrenia Clinical Trial
— QUALIPROCHESOfficial title:
Qualitative Study Among Relatives of Patients With Schizophrenia: Experience, Expectations and Impact of the Diagnostic Announcement
Verified date | September 2020 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The diagnostic announcement of a chronic disorder is an essential step in the patient's care.
Recommendations specify the importance of including caregivers at the time of the
announcement. In practice, caregivers are not systematically associated with the announcement
of the diagnosis of schizophrenia, while the daily support of patients is provided in 75% of
cases by the family. This support can lead to the exhaustion of caregivers and have
repercussions on their sick loved one.
This study will qualitatively describe and explore the experience of the diagnostic
announcement in relatives of patients with schizophrenia. Specifically, the investigators
will explore the history before the diagnosis is announced, the conditions of the
announcement and the experiences of relatives as well as the impact at the personal and
family-levels. This study will also explore the expectations of caregivers and avenues for
reflection for announcement of schizophrenia diagnosis.
The number of subjects to be included in this study is therefore set at 30. A preselection of
each potential participant will be carried out by phone or in person to ensure the presence
of inclusion criteria and the absence of non-inclusion criteria. The patients will also be
provided with oral information about the study to allow sufficient time to reflect before
inclusion. Then, the selection-inclusion-interview visit will take place visually in an
intra-hospital or extra-hospital consultation structure of the Center Hospitalier
Alpes-Isère. This visit will be unique and will consist of the entire protocol. It will be
both a selection, inclusion and interview visit.
Once the results have been analyzed, this study will provide a better understanding of the
experiences of relatives of patients when the diagnosis of schizophrenia is announced, the
impact of this announcement on caregivers and family relationships and the expectations of
caregivers regarding this announcement. In the long term, the data collected will be add
value in developing medical recommendations on consultation to announce the diagnosis of
schizophrenia to relatives of patients, in order to best meet the expectations of relatives
and to minimize as much as possible the harmful impact that can have such announcement.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | April 10, 2021 |
Est. primary completion date | March 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Family member of the 1st or 2nd degree of a person: - With a diagnosis of schizophrenia or schizoaffective disorder according to the criteria of the M.I.N.I. (Mini International Neuropsychiatric Interview) based on DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) - Whose diagnosis of schizophrenia or schizoaffective disorder was announced during a consultation with a psychiatrist less than 2 years ago. - Able to read, understand and speak the French language - Consent to the study and able to sign no objection Exclusion Criteria: - Presence of schizophrenia or a schizoaffective disorder - Guardianship measure or safeguard of justice - Agitation or major risk of suicide - Refusal to participate in the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Qualitative interviews | Analysis and interpretation of the transcripts from the semi-structured interviews. | Through study completion, an average of 6 months |
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