Efficacy of a Nurse-based Intervention on Tobacco Consumption in Hospitalized Patients (HOT)

November 19, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75010
        • Fernand Widal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1 month tobacco smoking prevalence
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
6 month tobacco smoking prevalence
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

June 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • HAO16020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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