Diagnostic Announcement to Relatives of Patients With Schizophrenia (QUALIPROCHES)
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Schizophrenia caregivers qualitative interview
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Schizophrenia caregiver (relative)
Arm Description
Outcomes
Primary Outcome Measures
Qualitative interviews
Analysis and interpretation of the transcripts from the semi-structured interviews.
Secondary Outcome Measures
Full Information
NCT ID
NCT04562961
First Posted
September 8, 2020
Last Updated
September 24, 2020
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT04562961
Brief Title
Diagnostic Announcement to Relatives of Patients With Schizophrenia
Acronym
QUALIPROCHES
Official Title
Qualitative Study Among Relatives of Patients With Schizophrenia: Experience, Expectations and Impact of the Diagnostic Announcement
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2020 (Anticipated)
Primary Completion Date
March 10, 2021 (Anticipated)
Study Completion Date
April 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Schizophrenia is a psychiatric disorder that affects 1% of the population worldwide. The diagnostic announcement of this 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Schizophrenia caregiver (relative)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Schizophrenia caregivers qualitative interview
Intervention Description
The semi-structured qualitative interview will be carried out in a focus group or individually for a period of 1 hour. Focus groups are a group interview technique, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on a limited number of pre-defined questions. In this study we foresee groups of 4 to 5 subjects. Focus groups will be privileged because they allow a better elaboration of the participants and therefore a better collection of data. If the focus group is not possible, the visit will be done individually. This interview will be framework-guided and recorded in their entirety and anonymously using a dictaphone and then transcribed the objective verbatim on a computer using word processing software. These transcriptions will be called the "verbatims". The source data recorded using a dictaphone will be stored in secure, locked cabinets located within the investigation center.
Primary Outcome Measure Information:
Title
Qualitative interviews
Description
Analysis and interpretation of the transcripts from the semi-structured interviews.
Time Frame
Through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Diagnostic Announcement to Relatives of Patients With Schizophrenia
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