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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
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 8, 2020
    Last Updated
    September 24, 2020
    Sponsor
    University Hospital, Grenoble
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    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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