Psychiatric DisorderHEPSYNCT05602870
Advanced Chronic Liver Disease Screening by Transient Elstography in Patients Hospitalised in a Psychiatric Unit
A study testing non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®) in people with Psychiatric Disorder and Psychiatric Hospitalization, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Scares data exists concerning the prevalence of chronic liver diseases in people with psychiatric disorders. There are still many barriers to screening and linkage to care for patients having somatic illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Disorder, Psychiatric Hospitalization, Advanced Chronic Liver Disease
- What is being tested?
- non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2023to 5 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults ≥18 years
- having a psychiatric condition and hospitalized in a psychiatry unit of CHU Montpellier , France
- patients who lack capacity of consent if legal representative consents
- involuntary psychiatric hospitalization, if consent is given
Who cannot join
- lack of written consent
- Unable to understand nature and objective of the methodology
- Pregnant or breast feeding woman
- Not affiliated with a French social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability of Advanced Chronic Liver Disease Screening by Transient Elstography (Fibroscan ®) in Patients Hospitalised in Psychiatric Unit: a Single Center Prospective Study
Scares data exists concerning the prevalence of chronic liver diseases in people with psychiatric disorders.
There are still many barriers to screening and linkage to care for patients having somatic illness.
Moreover follow-up of these patients may be difficult because of poor access to care, sometimes marginalization, and insufficient compliance with health programs.
The aim of this study is to asses acceptability of of advanced chronic liver disease screening by transient elstography (Fibroscan ®) in patients hospitalised in a psychiatric unit.
Read the detailed description
Scares data exists concerning the prevalence of chronic liver diseases in people with psychiatric disorders.
There are still many barriers to screening and linkage to care for patients having somatic illness.
Moreover follow-up of these patients may be difficult because of poor access to care, sometimes marginalization, and insufficient compliance with health programs.
Transient elastography is a useful tool validated for early diagnosis advanced chronic liver disease.It is non-invasive, fast, and gives immediate results.
The aim of this study is to assess acceptability of of advanced chronic liver disease screening by transient elstography (Fibroscan ®) in patients hospitalised in psychiatric unit.
Moreover, we will estimate de prevalence of advanced chronic liver diseases according to specific causes in psychiatry unit We hypothesize that the fact of offering psichiatric patents a non-invasive analysis of hepatic fibrosis will improve the detection of serious liver diseases and linkage to care.
- Conditions
- Psychiatric Disorder, Psychiatric Hospitalization, Advanced Chronic Liver Disease, Liver Fibrosis
- Being tested
- non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)
- Keywords
- psychiatric disorders, advanced liver disease, alcoholic liver diseases, viral hepatitis, transient elastography (Fibroscan ®)
- Medical subject headings
- Mental Disorders, Liver Cirrhosis, Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)Diagnostic test
A Fibroscan will be performed and the result will be given to the patient. A follow-up will be organized in the event of a diagnosis of severe fibrosis. If the serologies for hepatitis B and C cannont be recovered, patient will be able to benfit from a rapid diagnostic orientation test (TROD) (minimally invasive capillary venous sampling at the fingertip) for these 2 serologies.
| Study group | Role | What they receive |
|---|---|---|
| Psychiatric patient | Experimental | All patients having psychiatric disorders and hospitalised in a Psychiatry Unit of CHU Montpellier will have an non invasive evaluation of liver fibrosis after giving their consent Receives: Diagnostic Test: non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability of non invasive assessement of liver fibrosis by Fibroscan in psychiatric patients
Number of patient who have agreed to do fibroscan screening among patient to whom it was offered.
Measured: At Inclusion
Secondary outcomes (7)
Prevalence of advanced liver disease in psychiatric patients
Number of patient who are diagnosed with advanced liver disease among patient to whom it was offered.
Measured: At inclusion
prevalence of excessive alcohol or drug consumption in psychiatric patients
Number of patient with excessive alcohol/drug consumption
Measured: At inclusion
prevalence of passed or active drug consumption (intraveinous, inhaled or sniffed) in psychiatric patients
Number of patient with excessive alcohol/drug consumption
Measured: At Inclusion
prevalence of viral hepatitis in psychiatric patients
Number of patient diagnosed with viral hepatitis B, D, C
Measured: At Inclusion
correlation between advanced chronic liver diseases and risk factors for liver diseases in psychiatric patients
Number of patients with advanced chronic liver disease among those having risk factors for chronic liver disease
Measured: 1 to 3 month after inclusion
assessment of referral to medical care when advanced fibrosis was diagnosed, regardless of its etiology
Number of patients that have actually came to their medical appoint after advanced fibrosis diagnosis
Measured: 1 to 3 month after inclusion
reason for refusal of non invasive evaluation of chronic liver disease
rate of reasons of refusal according to reason of hospitalization, sector, duration of hospitalization, time spend in study explaination, patient reflection time
Measured: At Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start7 Mar 2023
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602870
- Sponsor's protocol ID
- RECHMPL22_0114
- Acronym
- HEPSY
- Status last verified
- Aug 2024
- First submitted
- 28 Oct 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Advanced Chronic Liver Disease Screening by Transient Elstography (Fibroscan ®) in Patients Hospitalised in Psychiatric Unit: a Single Center Prospective Study
- ClinicalTrials.gov ID
- NCT05602870
- Acronym / sponsor ID
- HEPSY / RECHMPL22_0114
- Conditions
- Psychiatric Disorder, Psychiatric Hospitalization, Advanced Chronic Liver Disease, Liver Fibrosis
- Keywords
- psychiatric disorders, advanced liver disease, alcoholic liver diseases, viral hepatitis, transient elastography (Fibroscan ®)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 2 Nov 2022 (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.
Scares data exists concerning the prevalence of chronic liver diseases in people with psychiatric disorders.
There are still many barriers to screening and linkage to care for patients having somatic illness.
Moreover follow-up of these patients may be difficult because of poor access to care, sometimes marginalization, and insufficient compliance with health programs.
The aim of this study is to asses acceptability of of advanced chronic liver disease screening by transient elstography (Fibroscan ®) in patients hospitalised in a psychiatric unit.
Detailed description
Scares data exists concerning the prevalence of chronic liver diseases in people with psychiatric disorders.
There are still many barriers to screening and linkage to care for patients having somatic illness.
Moreover follow-up of these patients may be difficult because of poor access to care, sometimes marginalization, and insufficient compliance with health programs.
Transient elastography is a useful tool validated for early diagnosis advanced chronic liver disease.It is non-invasive, fast, and gives immediate results.
The aim of this study is to assess acceptability of of advanced chronic liver disease screening by transient elstography (Fibroscan ®) in patients hospitalised in psychiatric unit.
Moreover, we will estimate de prevalence of advanced chronic liver diseases according to specific causes in psychiatry unit We hypothesize that the fact of offering psichiatric patents a non-invasive analysis of hepatic fibrosis will improve the detection of serious liver diseases and linkage to care.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychiatric patient | Experimental | Diagnostic Test: non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)All patients having psychiatric disorders and hospitalised in a Psychiatry Unit of CHU Montpellier will have an non invasive evaluation of liver fibrosis after giving their consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults ≥18 years
- having a psychiatric condition and hospitalized in a psychiatry unit of CHU Montpellier , France
- patients who lack capacity of consent if legal representative consents
- involuntary psychiatric hospitalization, if consent is given
Key exclusion criteria (4 listed)
- lack of written consent
- Unable to understand nature and objective of the methodology
- Pregnant or breast feeding woman
- Not affiliated with a French social security
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 |
|---|---|---|
| non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)A Fibroscan will be performed and the result will be given to the patient. A follow-up will be organized in the event of a diagnosis of severe fibrosis. If the serologies for hepatitis B and C cannont be recovered, patient will be able to benfit from a rapid diagnostic orientation test (TROD) (minimally invasive capillary venous sampling at the fingertip) for these 2 serologies. | Diagnostic test | Psychiatric patient |
Primary outcome
acceptability of non invasive assessement of liver fibrosis by Fibroscan in psychiatric patients
Time frame: At Inclusion
Number of patient who have agreed to do fibroscan screening among patient to whom it was offered.
7 secondary outcomes
Prevalence of advanced liver disease in psychiatric patients
Time frame: At inclusion
prevalence of excessive alcohol or drug consumption in psychiatric patients
Time frame: At inclusion
prevalence of passed or active drug consumption (intraveinous, inhaled or sniffed) in psychiatric patients
Time frame: At Inclusion
prevalence of viral hepatitis in psychiatric patients
Time frame: At Inclusion
correlation between advanced chronic liver diseases and risk factors for liver diseases in psychiatric patients
Time frame: 1 to 3 month after inclusion
assessment of referral to medical care when advanced fibrosis was diagnosed, regardless of its etiology
Time frame: 1 to 3 month after inclusion
reason for refusal of non invasive evaluation of chronic liver disease
Time frame: At Inclusion
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 5 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®) in people with Psychiatric Disorder and Psychiatric Hospitalization, 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 4 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: finished, as of the sponsor's last update on 5 Aug 2024. 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?
acceptability of non invasive assessement of liver fibrosis by Fibroscan in psychiatric patients (time frame: At Inclusion). 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 5 Aug 2024.