Anorexia NervosaQUALICOVIDNCT04387708
Care in Patients Hospitalized for Anorexia Nervosa at the Time of the Coronavirus-19 Epidemic (QUALICOVID)
An observational study of Anorexia Nervosa, run by Centre Psychothérapique de Nancy at 1 site in France.
Trial summary
Anorexia nervosa is a severe psychiatric condition. On the nutritional level, one of the objectives recommended by the High Authority of Health is to "achieve and maintain an appropriate weight and nutritional status". Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2020to 20 May 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The source population represents six patients, aged 9 to 17 years in March 2020 and their parents. Four of the six patients went home on the day the lockdown measures were announced, one patient went home three days later so that her parents would be available, and one patient remained in hospital because of a physical condition incompatible with a return home. The population is therefore made up of 18 people: patients (6) and their parents (12). It will be possible to interview the parent(s) without interviewing the child if the child refuses to participate in the study.
Who may be able to join
- Criteria for inclusion :
- 1/ For patients :
- To have been hospitalized in the child and adolescent psychiatry unit of the Pôle Universitaire de Psychiatrie de l'Enfant et de l'Adolescent du Centre Psychothérapique de Nancy on 16 March 2020
- With a diagnosis of anorexia nervosa (ICD-10 F500)
- Understand and speak French fluently
- Have been informed of the study, have received the study briefing note and have not objected to participating in the study.
Show all 12Show fewer
- That the holders of parental authority have been informed of the study, have received the information note on the study and have not objected to their child's participation
- Be affiliated to or entitled to a social security scheme
- 2/ For the parents :
- To have a child who meets the inclusion criteria mentioned above.
- Understand and speak French fluently
- Have been informed of the study, have received the study briefing note and have not objected to participating in the study.
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reorganization of Care in Patients Hospitalized in Child Psychiatry for Anorexia Nervosa at the Time of the Coronavirus-19 Epidemic in France: Qualitative Study Carried Out on Patients and Their Parents
Anorexia nervosa is a severe psychiatric condition. On the nutritional level, one of the objectives recommended by the High Authority of Health is to "achieve and maintain an appropriate weight and nutritional status". It is recommended that, in the event of hospitalisation, this should be "as long as necessary" and be based on a weight contract as a condition for discharge. Within the Pôle Universitaire de Psychiatrie de l'Enfant et de l'Adolescent of the Centre Psychothérapique de Nancy, an inpatient unit takes care of children and adolescents with a specific valence in the management of patients suffering from eating disorders.
Since the first quarter of 2020, France has been progressively affected by the pandemic of the coronavirus 2019, Covid-19. This pandemic has led to unprecedented containment measures in France and around the world.
Read more
At the time of the announcement of the implementation of containment, the investigators proposed to the parents of patients hospitalized in the Child and Adolescent Psychiatry Department of the Nancy Psychotherapy Center who were approaching their discharge weight to be able to end their hospitalization prematurely. As a follow-up to this hospitalisation, intensive outpatient care was offered to the families, in accordance with State recommendations in connection with the pandemic. In this hospitalized unit, weekly outpatient consultations were maintained and coupled with telephone interviews, teleconsultation interviews and a telephone hotline for the healthcare team.
The objective of the study is to explore, in a qualitative way, the experiences of patients hospitalized in the child psychiatry department for anorexia nervosa at the time of the coronavirus epidemic in France and those of their parents, in relation to the reorganization of care.
Read the detailed description
Interviews will be recorded, made anonymous and transcribed verbatim. The resulting text will be subjected to an inductive thematic analysis. The investigators will analyse the interviews to identify themes. Then, based on the preliminary results, higher key themes will be proposed, i.e. the themes most present and salient in the material. They will look for a concordance between the different members of each family. Several profiles may be proposed based on the patient's and parents' experiences and will be presented in the form of a thematic tree.
The study will be proposed to all eligible patients in order to obtain as much material as possible.
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, child psychiatry, covid-19, qualitative study
- Medical subject headings
- Anorexia Nervosa, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Content analysis concerning the reorganization of care for children or adolescent and thier parents
Analyzing the discourse content regarding the experiences related to changes in the care of patients with anorexia nervosa hospitalized in a child and adolescent psychiatric ward in Nancy, France, and their parents, in the context of the Covid-19 crisis.
Measured: 1 interview for each participant during 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start12 May 2020
- Primary completion20 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilou Lamourette, MD, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387708
- Sponsor's protocol ID
- RIPH 2020-01
- Other IDs
- IDRCB 2020-A01101-38
- Acronym
- QUALICOVID
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 20 Dec 2021
- 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 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reorganization of Care in Patients Hospitalized in Child Psychiatry for Anorexia Nervosa at the Time of the Coronavirus-19 Epidemic in France: Qualitative Study Carried Out on Patients and Their Parents
- ClinicalTrials.gov ID
- NCT04387708
- Acronym / sponsor ID
- QUALICOVID / RIPH 2020-01
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, child psychiatry, covid-19, qualitative study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 14 May 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.
Anorexia nervosa is a severe psychiatric condition. On the nutritional level, one of the objectives recommended by the High Authority of Health is to "achieve and maintain an appropriate weight and nutritional status". It is recommended that, in the event of hospitalisation, this should be "as long as necessary" and be based on a weight contract as a condition for discharge. Within the Pôle Universitaire de Psychiatrie de l'Enfant et de l'Adolescent of the Centre Psychothérapique de Nancy, an inpatient unit takes care of children and adolescents with a specific valence in the management of patients suffering from eating disorders.
Since the first quarter of 2020, France has been progressively affected by the pandemic of the coronavirus 2019, Covid-19. This pandemic has led to unprecedented containment measures in France and around the world.
At the time of the announcement of the implementation of containment, the investigators proposed to the parents of patients hospitalized in the Child and Adolescent Psychiatry Department of the Nancy Psychotherapy Center who were approaching their discharge weight to be able to end their hospitalization prematurely. As a follow-up to this hospitalisation, intensive outpatient care was offered to the families, in accordance with State recommendations in connection with the pandemic. In this hospitalized unit, weekly outpatient consultations were maintained and coupled with telephone interviews, teleconsultation interviews and a telephone hotline for the healthcare team.
The objective of the study is to explore, in a qualitative way, the experiences of patients hospitalized in the child psychiatry department for anorexia nervosa at the time of the coronavirus epidemic in France and those of their parents, in relation to the reorganization of care.
Detailed description
Interviews will be recorded, made anonymous and transcribed verbatim. The resulting text will be subjected to an inductive thematic analysis. The investigators will analyse the interviews to identify themes. Then, based on the preliminary results, higher key themes will be proposed, i.e. the themes most present and salient in the material. They will look for a concordance between the different members of each family. Several profiles may be proposed based on the patient's and parents' experiences and will be presented in the form of a thematic tree.
The study will be proposed to all eligible patients in order to obtain as much material as possible.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The source population represents six patients, aged 9 to 17 years in March 2020 and their parents. Four of the six patients went home on the day the lockdown measures were announced, one patient went home three days later so that her parents would be available, and one patient remained in hospital because of a physical condition incompatible with a return home. The population is therefore made up of 18 people: patients (6) and their parents (12). It will be possible to interview the parent(s) without interviewing the child if the child refuses to participate in the study.
Key inclusion criteria (12 listed)
- Criteria for inclusion :
- To have been hospitalized in the child and adolescent psychiatry unit of the Pôle Universitaire de Psychiatrie de l'Enfant et de l'Adolescent du Centre Psychothérapique de Nancy on 16 March 2020
- With a diagnosis of anorexia nervosa (ICD-10 F500)
- Understand and speak French fluently
- Have been informed of the study, have received the study briefing note and have not objected to participating in the study.
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Content analysis concerning the reorganization of care for children or adolescent and thier parents
Time frame: 1 interview for each participant during 45 minutes
Analyzing the discourse content regarding the experiences related to changes in the care of patients with anorexia nervosa hospitalized in a child and adolescent psychiatric ward in Nancy, France, and their parents, in the context of the Covid-19 crisis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- 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.
Marilou Lamourette, MD principal investigator
Centre Psychothérapique de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Centre Psychothérapique de Nancy at 1 site in France.
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 12 inclusion and 1 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: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Content analysis concerning the reorganization of care for children or adolescent and thier parents (time frame: 1 interview for each participant during 45 minutes). 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 20 Dec 2021.