Consumption, TobaccoNCT04333030
Study on the Level of Information on the Risks Related to Tobacco of Persons Consulting in Psychiatry and on Access to Aids in Case of Smoking, Comparing With Persons Consulting in Diabetology or in Addictology
An observational study of Consumption, Tobacco, run by Versailles Hospital at 2 sites in France.
Trial summary
this is an observational study that involves providing a questionnaire to patients consulting in psychiatry, addictology (other than tobacco) and endocrinology to assess their knowledge of tobacco risks and access to smoking cessation aids Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consumption, Tobacco
- What is being tested?
- questionnaire
- How many people
- 310 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Aug 2019to 31 Dec 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: patients who come at : * Department of Psychiatry for Adults of the Hospital of Versailles of Dr N Bazin (André Mignot in Chesnay): CMP (Centre Médico-psychologique), HDJ (Day Hospital). * Endocrinology service of Dr JP Beressi of the Hospital of Versailles (André Mignot in Chesnay): consultation, HDJ * Addictology service CSAPA (Espace Murger) by Dr F Vorspan of the Fernand-Widal Hospital in Paris
Who may be able to join
- Patients > 18 years
- Men and women
- who comes for consultation during the study
- Psychiatry on CMP or HDJ, regardless of diagnosis or smoking status
- Endocrinology in consultation or HDJ
- In addictology at CSAPA
Who cannot join
- Patient unable to complete questionnaire (not speaking French, confused, alcoholics, etc.)
- Refusal to complete questionnaire
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier de Versailles
Le Chesnay, 78150
Hôpital Ferdinand Widal
Paris
About this study
Official title: INFO-AIDE-TABAC Study on the Level of Information on the Risks Related to Tobacco of Persons Consulting in Psychiatry and on Access to Aids in Case of Smoking, Comparing With Persons Consulting in Diabetology or in Addictology
this is an observational study that involves providing a questionnaire to patients consulting in psychiatry, addictology (other than tobacco) and endocrinology to assess their knowledge of tobacco risks and access to smoking cessation aids
- Conditions
- Consumption, Tobacco
- Being tested
- questionnaire
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Tobacco Use and Risk Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Psychiatry | patients who come for psychiatric consultation Receives: Other: questionnaire | |
| addictology (other than tabacco) | patients who come for addictology consultation Receives: Other: questionnaire | |
| endocrinology | patients who come for endocrinology consultation Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
to Assess the level of information on tobacco-related risks of patients with questionnaire
to Assess the level of information on tobacco-related risks of patients monitored for psychiatric disorders by comparing them to patients monitored for an addiction other than tobacco or to patients monitored for a chronic disease
Measured: at the end of study, average 2 month
to Assess access to smoking cessation aids for smokers and ex-smokers with questionnaire
to Assess access to smoking cessation aids for smokers and ex-smokers among psychiatric patients compared to smokers and ex-smokers among patients who have been monitored for an addiction other than tobacco or among patients who have been monitored for a chronic disease (endocrine).
Measured: at the end of study, average 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start12 Aug 2019
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consumption, TobaccoStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nadia YOUNES, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333030
- Sponsor's protocol ID
- P19/12_info_aide_tabac
- Status last verified
- Aug 2021
- First submitted
- 28 Feb 2020
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFO-AIDE-TABAC Study on the Level of Information on the Risks Related to Tobacco of Persons Consulting in Psychiatry and on Access to Aids in Case of Smoking, Comparing With Persons Consulting in Diabetology or in Addictology
- ClinicalTrials.gov ID
- NCT04333030
- Acronym / sponsor ID
- P19/12_info_aide_tabac
- Conditions
- Consumption, Tobacco
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Apr 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.
this is an observational study that involves providing a questionnaire to patients consulting in psychiatry, addictology (other than tobacco) and endocrinology to assess their knowledge of tobacco risks and access to smoking cessation aids
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychiatry | – | Other: questionnairepatients who come for psychiatric consultation |
| addictology (other than tabacco) | – | Other: questionnairepatients who come for addictology consultation |
| endocrinology | – | Other: questionnairepatients who come for endocrinology consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who come at : * Department of Psychiatry for Adults of the Hospital of Versailles of Dr N Bazin (André Mignot in Chesnay): CMP (Centre Médico-psychologique), HDJ (Day Hospital). * Endocrinology service of Dr JP Beressi of the Hospital of Versailles (André Mignot in Chesnay): consultation, HDJ * Addictology service CSAPA (Espace Murger) by Dr F Vorspan of the Fernand-Widal Hospital in Paris
Key inclusion criteria (6 listed)
- Patients > 18 years
- Men and women
- who comes for consultation during the study
- Psychiatry on CMP or HDJ, regardless of diagnosis or smoking status
- Endocrinology in consultation or HDJ
Key exclusion criteria (2 listed)
- Patient unable to complete questionnaire (not speaking French, confused, alcoholics, etc.)
- Refusal to complete questionnaire
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 |
|---|---|---|
| questionnaireTobacco Use and Risk Questionnaire | Other | Psychiatry, addictology (other than tabacco), endocrinology |
Primary outcome
to Assess the level of information on tobacco-related risks of patients with questionnaire
Time frame: at the end of study, average 2 month
to Assess the level of information on tobacco-related risks of patients monitored for psychiatric disorders by comparing them to patients monitored for an addiction other than tobacco or to patients monitored for a chronic disease
to Assess access to smoking cessation aids for smokers and ex-smokers with questionnaire
Time frame: at the end of study, average 2 month
to Assess access to smoking cessation aids for smokers and ex-smokers among psychiatric patients compared to smokers and ex-smokers among patients who have been monitored for an addiction other than tobacco or among patients who have been monitored for a chronic disease (endocrine).
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 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consumption, Tobacco, run by Versailles Hospital at 2 sites 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 6 inclusion and 2 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 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
to Assess the level of information on tobacco-related risks of patients with questionnaire (time frame: at the end of study, average 2 month). The study lists 2 primary outcomes in all. 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 2021.