COVID 19HoCoPsyNCT04417374
Caracteristics of the Patients Hospitalized With Unvonluntary Commitment Procedure, in the Context COVID-19
An observational study of COVID 19 and Disease Outbreak, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The actual worldwide context (disease outbreak, confinements instaured in many countries) is a stressful factor for many people. It can have consequences on mental health : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19, Disease Outbreak, Mental Disorders
- What is being tested?
- Description of groups caracteristics
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 30 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults having been aditted to the psychiatric hospital La Colombière, CHU Montpellier, France, with unvonluntary commitment procedure from march 12th to April 09th (2019 and 2020)
Who may be able to join
- Unvonluntary commitment in psychiatric hospital La Colombière, CHU Montpellier, from march 12th to april 19th (2019 and 2020).
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caracteristics of the Patients Hospitalized With Unvonluntary Commitment Procedure, in Pandemic and Confinement Context
The actual worldwide context (disease outbreak, confinements instaured in many countries) is a stressful factor for many people. It can have consequences on mental health : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. Patients with mental disorders are especially vulnerable.
On march 17th, the french government ordonned a national confinement to slow the progression of the COVID-19 outbreak, for 15 days at first then renewed several times. This situation has led to a reorganization of care as requested on March 22nd, 2020 in the recommendations applicable to the organization of care in psychiatric services : priority to telephone contacts and teleconsultation by multiplying contacts and assessments.
Read more
By the time the reorganization of care became operational, the most vulnerable patients may have experienced a decompensation of their disease.
It is important to know if the COVID-19 outbreak combined with the confinement increased the number of unvoluntary commitment the month after the announce of the confinement.
This could help us understand which patients are more vulnerable is this context, and improve our organization (ambulatory and hospitalization care) if this situation occurs again.
Read the detailed description
The main objective is to notice if we can observe a increase in the number of unvonluntary commitment the month after the announce of the confinement in the psychiatric hospital La Colombière, CHU Montpellier, France.
Secondary objectives :
- Describe the causes of unvonluntary commitment, and the principal psychiatric diagnostic of the patients
- Assess the lengh of the hospitalization
- Assess the number of patients hospitalized without psychiatric antecedent
- Assess the number of treatment interruptions in the recent history before hospitalization
- Asses the number of patients living alone
- Asses the number of patients using drugs
It is expected to highlight :
- An increase of the number of unvontuntary commitment
- If one or several mental disorders were more at risk of requiring an unvonluntary commitment
- An increased lengh of hospitalization
- An increased number of unvonluntary commitment of patients without psychiatric antecedent
- An increased number of treatment interruptions
- A link between hospitalization and living alone
- A link between hospitalization and using drugs
The medical file of all the patients unvonlutary commited from march 12th to April 09th 2020 are screened, and compared to the patients unvonlutary commited during the same period in 2019.
The caracteristics of interest are their age and sex, if the patient lives alone, the matter of hospitalization, its lengh, their primary psychiatric diagnostic, the use of toxics at the moment of the hospitalization and if this psychiatric decompensation happens in a context of treatment interruption.
- Conditions
- COVID 19, Disease Outbreak, Mental Disorders
- Being tested
- Description of groups caracteristics
- Keywords
- Confinement, Disease outbreak, Unvonluntary commitment
- Medical subject headings
- COVID-19, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of groups caracteristicsOther
Comparison of the two groups on all the following criterias : age, sex, if the patient lives alone, the matter of hospitalization, its lengh, their primary psychiatric diagnostic, the use of toxics at the moment of the hospitalization and if this psychiatric decompensation happens in a context of treatment interruption.
| Study group | Role | What they receive |
|---|---|---|
| Unvonluntary commitment from March 12th to April 09th 2019 | Patients hospitalized with unvonluntary commitment procedure from March 12th to April 09th 2019 Receives: Other: Description of groups caracteristics | |
| Unvonluntary commitment from March 12th to April 09th 2020 | Patients hospitalized with unvonluntary commitment procedure from March 12th to April 09th 2020 Receives: Other: Description of groups caracteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalized patients
Number of hospitalized patients From March 12th to April 09th
Measured: 1 months
Secondary outcomes (1)
Cause of hospitalization
Primary psychiatric diagnostic From March 12th to April 09th
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 May 2020
- Primary completion30 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Olie, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417374
- Sponsor's protocol ID
- RECHMPL20_0320
- Acronym
- HoCoPsy
- Status last verified
- Jul 2020
- First submitted
- 3 Jun 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caracteristics of the Patients Hospitalized With Unvonluntary Commitment Procedure, in Pandemic and Confinement Context
- ClinicalTrials.gov ID
- NCT04417374
- Acronym / sponsor ID
- HoCoPsy / RECHMPL20_0320
- Conditions
- COVID 19, Disease Outbreak, Mental Disorders
- Keywords
- Confinement, Disease outbreak, Unvonluntary commitment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 4 Jun 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 actual worldwide context (disease outbreak, confinements instaured in many countries) is a stressful factor for many people. It can have consequences on mental health : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. Patients with mental disorders are especially vulnerable.
On march 17th, the french government ordonned a national confinement to slow the progression of the COVID-19 outbreak, for 15 days at first then renewed several times. This situation has led to a reorganization of care as requested on March 22nd, 2020 in the recommendations applicable to the organization of care in psychiatric services : priority to telephone contacts and teleconsultation by multiplying contacts and assessments.
By the time the reorganization of care became operational, the most vulnerable patients may have experienced a decompensation of their disease.
It is important to know if the COVID-19 outbreak combined with the confinement increased the number of unvoluntary commitment the month after the announce of the confinement.
This could help us understand which patients are more vulnerable is this context, and improve our organization (ambulatory and hospitalization care) if this situation occurs again.
Detailed description
The main objective is to notice if we can observe a increase in the number of unvonluntary commitment the month after the announce of the confinement in the psychiatric hospital La Colombière, CHU Montpellier, France.
Secondary objectives :
- Describe the causes of unvonluntary commitment, and the principal psychiatric diagnostic of the patients
- Assess the lengh of the hospitalization
- Assess the number of patients hospitalized without psychiatric antecedent
- Assess the number of treatment interruptions in the recent history before hospitalization
- Asses the number of patients living alone
- Asses the number of patients using drugs
It is expected to highlight :
- An increase of the number of unvontuntary commitment
- If one or several mental disorders were more at risk of requiring an unvonluntary commitment
- An increased lengh of hospitalization
- An increased number of unvonluntary commitment of patients without psychiatric antecedent
- An increased number of treatment interruptions
- A link between hospitalization and living alone
- A link between hospitalization and using drugs
The medical file of all the patients unvonlutary commited from march 12th to April 09th 2020 are screened, and compared to the patients unvonlutary commited during the same period in 2019.
The caracteristics of interest are their age and sex, if the patient lives alone, the matter of hospitalization, its lengh, their primary psychiatric diagnostic, the use of toxics at the moment of the hospitalization and if this psychiatric decompensation happens in a context of treatment interruption.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unvonluntary commitment from March 12th to April 09th 2019 | – | Other: Description of groups caracteristicsPatients hospitalized with unvonluntary commitment procedure from March 12th to April 09th 2019 |
| Unvonluntary commitment from March 12th to April 09th 2020 | – | Other: Description of groups caracteristicsPatients hospitalized with unvonluntary commitment procedure from March 12th to April 09th 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults having been aditted to the psychiatric hospital La Colombière, CHU Montpellier, France, with unvonluntary commitment procedure from march 12th to April 09th (2019 and 2020)
Key inclusion criteria (1 listed)
- Unvonluntary commitment in psychiatric hospital La Colombière, CHU Montpellier, from march 12th to april 19th (2019 and 2020).
Key exclusion criteria (1 listed)
- refusal to participate
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 |
|---|---|---|
| Description of groups caracteristicsComparison of the two groups on all the following criterias : age, sex, if the patient lives alone, the matter of hospitalization, its lengh, their primary psychiatric diagnostic, the use of toxics at the moment of the hospitalization and if this psychiatric decompensation happens in a context of treatment interruption. | Other | Unvonluntary commitment from March 12th to April 09th 2019, Unvonluntary commitment from March 12th to April 09th 2020 |
Primary outcome
Number of hospitalized patients
Time frame: 1 months
Number of hospitalized patients From March 12th to April 09th
1 secondary outcome
Cause of hospitalization
Time frame: 1 months
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 29 Jul 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Emilie Olie, MD PhD principal investigator
University Hospital, Montpellier
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 COVID 19 and Disease Outbreak, run by University Hospital, Montpellier 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 1 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 29 Jul 2020. 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?
Number of hospitalized patients (time frame: 1 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 29 Jul 2020.