Smoking PatientsHOTNCT03281642
Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients
An observational study of Smoking Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Tobacco consumption is a major public health problem, ranking second in the leading cause of morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized patients is evaluated around 20% and the management of tobacco reduction/cessation is an major issue for the course and outcome of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Patients
- What is being tested?
- Tobacco management
- How many people
- 430 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2017to 1 Jan 2021
- 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: All smoking patients hospitalized in one of the participating unit of the Saint-Louis-Lariboisière-Fernand Widal hospital (Diabetology, Cardiology, adults and adolescents Onco-hématology, Orthopedy, Oncology, Internal Medecine, Pneumology, Dermatology, Rhumatology, Psychiatry, Gastro-Entérology, Neurology) during the study period that include the 6 months preceding and the 6 months following the training.
Who may be able to join
- Adult patient (>= 18 years), tobacco smokers, hospitalized in one of the participating unit during the inclusion period.
- For the sake of coherence with the literature, only subjects who smoked at least one cigarette a day in the previous 30 days before the hospitalization will be considered as "smokers".
- Affiliated to the national health system
- Signed informed consent
Who cannot join
- Patients enrolled in an addiction treatment during their hospitalization stay
- Cognitive deficit that makes the informed consent and the telephone interview impossible
- Aphasia
- Patient who does not speak French
- Life expectancy below 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Tobacco consumption is a major public health problem, ranking second in the leading cause of morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized patients is evaluated around 20% and the management of tobacco reduction/cessation is an major issue for the course and outcome of many disorders.
Recent recommendations published by the French National Health Authority ("Haute Autorité de Santé", HAS) call for the involvement of all health professionals in helping patients to stop smoking and hospitalized patients are identified as a specific target. In addition, the meta-analysis of Rigotti et al. (2012) showed that the most effective programs (tobacco cessation) were those that include all patients, starting during the hospitalization with a specific follow-up of at least one month, and with the addition of nicotine replacement therapy. This combination increased the odds of successful tobacco cessation by 54%.
The project aims to evaluate the short-term efficacy (1 month) of a nurse-based program on tobacco smoking consumption in a population of hospitalized patients.
- Conditions
- Smoking Patients
- Being tested
- Tobacco management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco managementOther
Also called Training of healthcare teams for tobacco management
Training of healthcare teams for tobacco management by trained nurses. The intervention will consist of 3 minimum interviews, about 30 minutes each.
What is being measured
The primary outcome is the main question the study is designed to answer.
1 month tobacco smoking prevalence
Measured: 1 month
Secondary outcomes (1)
6 month tobacco smoking prevalence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Nov 2017
- Primary completion1 Jun 2020
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Time perspective
- Other
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281642
- Sponsor's protocol ID
- HAO16020
- Acronym
- HOT
- Status last verified
- Nov 2020
- First submitted
- 11 Sep 2017
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT03281642
- Acronym / sponsor ID
- HOT / HAO16020
- Conditions
- Smoking Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 13 Sep 2017 (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.
Tobacco consumption is a major public health problem, ranking second in the leading cause of morbidity and mortality worldwide, in 2010. The prevalence of tobacco smoking in hospitalized patients is evaluated around 20% and the management of tobacco reduction/cessation is an major issue for the course and outcome of many disorders.
Recent recommendations published by the French National Health Authority ("Haute Autorité de Santé", HAS) call for the involvement of all health professionals in helping patients to stop smoking and hospitalized patients are identified as a specific target. In addition, the meta-analysis of Rigotti et al. (2012) showed that the most effective programs (tobacco cessation) were those that include all patients, starting during the hospitalization with a specific follow-up of at least one month, and with the addition of nicotine replacement therapy. This combination increased the odds of successful tobacco cessation by 54%.
The project aims to evaluate the short-term efficacy (1 month) of a nurse-based program on tobacco smoking consumption in a population of hospitalized patients.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All smoking patients hospitalized in one of the participating unit of the Saint-Louis-Lariboisière-Fernand Widal hospital (Diabetology, Cardiology, adults and adolescents Onco-hématology, Orthopedy, Oncology, Internal Medecine, Pneumology, Dermatology, Rhumatology, Psychiatry, Gastro-Entérology, Neurology) during the study period that include the 6 months preceding and the 6 months following the training.
Key inclusion criteria (4 listed)
- Adult patient (>= 18 years), tobacco smokers, hospitalized in one of the participating unit during the inclusion period.
- For the sake of coherence with the literature, only subjects who smoked at least one cigarette a day in the previous 30 days before the hospitalization will be considered as "smokers".
- Affiliated to the national health system
- Signed informed consent
Key exclusion criteria (5 listed)
- Patients enrolled in an addiction treatment during their hospitalization stay
- Cognitive deficit that makes the informed consent and the telephone interview impossible
- Aphasia
- Patient who does not speak French
- Life expectancy below 6 months
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 |
|---|---|---|
| Tobacco managementAlso: Training of healthcare teams for tobacco managementTraining of healthcare teams for tobacco management by trained nurses. The intervention will consist of 3 minimum interviews, about 30 minutes each. | Other | – |
Primary outcome
1 month tobacco smoking prevalence
Time frame: 1 month
1 secondary outcome
6 month tobacco smoking prevalence
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Smoking Patients, run by Assistance Publique - Hôpitaux de Paris 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 5 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 20 Nov 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?
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?
1 month tobacco smoking prevalence (time frame: 1 month). 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 Nov 2020.