SchizophreniaQUALIPROCHESNCT04562961
Diagnostic Announcement to Relatives of Patients With Schizophrenia
A study testing Schizophrenia caregivers qualitative interview in people with Schizophrenia, run by University Hospital, Grenoble.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Schizophrenia caregivers qualitative interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2020to 10 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Qualitative Study Among Relatives of Patients With Schizophrenia: Experience, Expectations and Impact of the Diagnostic Announcement
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.
Read more
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Schizophrenia caregivers qualitative interview
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schizophrenia caregivers qualitative interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia caregiver (relative) | Experimental | Not described Receives: Other: Schizophrenia caregivers qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative interviews
Analysis and interpretation of the transcripts from the semi-structured interviews.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start10 Oct 2020 (estimated)
- Primary completion10 Mar 2021 (estimated)
- Study completion10 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562961
- Sponsor's protocol ID
- 38RC20.158
- Other IDs
- 2020-A01276-33
- Acronym
- QUALIPROCHES
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Study Among Relatives of Patients With Schizophrenia: Experience, Expectations and Impact of the Diagnostic Announcement
- ClinicalTrials.gov ID
- NCT04562961
- Acronym / sponsor ID
- QUALIPROCHES / 38RC20.158
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 10 Oct 2020 (estimated)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 10 Apr 2021 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia caregiver (relative) | Experimental | Other: Schizophrenia caregivers qualitative interview |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Family member of the 1st or 2nd degree of a person:
- Able to read, understand and speak the French language
- Consent to the study and able to sign no objection
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schizophrenia caregivers qualitative interviewThe 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. | Other | Schizophrenia caregiver (relative) |
Primary outcome
Qualitative interviews
Time frame: Through study completion, an average of 6 months
Analysis and interpretation of the transcripts from the semi-structured interviews.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Schizophrenia caregivers qualitative interview in people with Schizophrenia, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative interviews (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.