Smoking CessationInterventionNCT06923852
Acute Respiratory Disease as a Fulcrum Point to Quit Smoking: Evaluation of an ED-based Intervention
An observational study of Smoking Cessation and Emergency Department Visit, run by Seda Oğuz.
Trial summary
This study aims to evaluate smoking cessation success rates using the Fagerström Test for Nicotine Dependence (FTND) in smoking cessation treatment. The study has a retrospective design, analyzing data from patients who applied to a smoking cessation clinic to investigate the impact of nicotine dependence severity on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Emergency Department Visit, Acute Respiratory Infections (ARIs)
- What is being tested?
- Smoking cessation support that World Health Organization (WHO) 5A model (Ask, Advise, Assess, Assist, Arrange).
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2016to 10 Jan 2017
- How long will I take part?
- 1 Month
- 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: A total of 20,928 patients presented to the ED during the specified period and 2,018 of these patients were evaluated with acute respiratory complaints diagnosed with ARI. Of the patients admitted with ARI, 541 reported active smoking. Finally, 288 participants were accepted for the study.
Who may be able to join
- Patients who were active smokers and admitted to the emergency department with acute respiratory system complaints.
Who cannot join
- Exclusion criteria included individuals under 18 years of age, ASA class III-IV, pregnancy or breastfeeding, communication difficulties such as language barrier or cognitive impairment, psychotic behaviors or history of psychiatric treatment, and initiation of smoking cessation treatment.
About this study
This study aims to evaluate smoking cessation success rates using the Fagerström Test for Nicotine Dependence (FTND) in smoking cessation treatment. The study has a retrospective design, analyzing data from patients who applied to a smoking cessation clinic to investigate the impact of nicotine dependence severity on quitting success.
Read the detailed description
Emergency departments (EDs) are among the most critical referral centers for individuals with health problems resulting from the direct and indirect effects of smoking. Individuals may be more motivated to change their smoking habits, especially during acute attacks of respiratory diseases. The American College of Emergency Physicians (ACEP) and some organizations recommend that interventions for smoking cessation should be implemented by physicians and nurses in the form of counseling for patients with active smoking who receive treatment for acute respiratory infections (ARI) in EDs. However, interventions for smoking cessation are frequently performed in primary health care institutions and according to studies, a high majority of emergency physicians think that EDs are not the appropriate place for this intervention and are not included in their professional responsibilities.
The effect of nicotine dependence (ND) severity on smoking cessation has been shown in studies. Fagerström Test of Nicotine Dependence (FTND) developed by Fagerström et al. is a widely used tool to measure the ND level of individuals. The Turkish validity and reliability study of the test was conducted by Uysal et al. In the approach to smoking cessation, ND level comes to the forefront in determining personalized intervention strategies. At high levels of addiction, nicotine replacement therapy or pharmacologic support is recommended because the physical and psychological dependence of individuals is more intense. In these cases, motivational counseling and regular follow-up are necessary during the cessation process. At moderate levels of addiction, nicotine replacement products or behavioral therapies are usually recommended, while less pharmacological intervention may be required. At low levels of addiction, behavioral support and counseling may be sufficient for smoking cessation. Pharmacologic treatment is usually not needed in these individuals, but education and awareness-raising methods that support smoking cessation can be used. Intervention with strategies appropriate to the level of ND is a crucial factor in increasing the success of smoking cessation.
When determining the assistance method in individuals who want to quit smoking; WHO recommends five major steps (5A) in smoking cessation treatment. In practice, the "Ask, Advise, Assess, Assist, Arrange" approach is an evidence-based smoking cessation model that has been developed to provide effective interventions in a short time, especially in busy working environments.
This study aimed to examine the effects of short structured interviews with patients who presented to the ED due to ARI on smoking cessation behavior and to follow up for one month. It is aimed to evaluate the applicability of smoking cessation interventions on those with ARI in EDs.
- Being tested
- Smoking cessation support that World Health Organization (WHO) 5A model (Ask, Advise, Assess, Assist, Arrange).
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation support that World Health Organization (WHO) 5A model (Ask, Advise, Assess, Assist, Arrange).Behavioural
Smoking cessation support that World Health Organization (WHO) 5A model (Ask, Advise, Assess, Assist, Arrange).
| Study group | Role | What they receive |
|---|---|---|
| Active smokers who attend the emergency depertment with acute respiratory infections | Not described Receives: Behavioral: Smoking cessation support that World Health Organization (WHO) 5A model (Ask, Advise, Assess, Assist, Arrange). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation success on acute respiratory infections patients based on FTND score
Examine the effects of short structured interviews with patients who presented to the ED due to ARI on smoking cessation behavior. It is aimed to evaluate the applicability of smoking cessation interventions on those with ARI in EDs.
Measured: Two periods as first week after intervention and first month after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start10 Nov 2016
- Primary completion10 Jan 2017
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 288 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Seda Oğuz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seda Oğuz, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923852
- Sponsor's protocol ID
- SMOKE-21041991
- Acronym
- Intervention
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 11 Apr 2025
- 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 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Respiratory Disease as a Fulcrum Point to Quit Smoking: Evaluation of an ED-based Intervention
- ClinicalTrials.gov ID
- NCT06923852
- Acronym / sponsor ID
- Intervention / SMOKE-21041991
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Seda OğuzUniversity, hospital or other
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 11 Apr 2025 (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 study aims to evaluate smoking cessation success rates using the Fagerström Test for Nicotine Dependence (FTND) in smoking cessation treatment. The study has a retrospective design, analyzing data from patients who applied to a smoking cessation clinic to investigate the impact of nicotine dependence severity on quitting success.
Detailed description
Emergency departments (EDs) are among the most critical referral centers for individuals with health problems resulting from the direct and indirect effects of smoking. Individuals may be more motivated to change their smoking habits, especially during acute attacks of respiratory diseases. The American College of Emergency Physicians (ACEP) and some organizations recommend that interventions for smoking cessation should be implemented by physicians and nurses in the form of counseling for patients with active smoking who receive treatment for acute respiratory infections (ARI) in EDs. However, interventions for smoking cessation are frequently performed in primary health care institutions and according to studies, a high majority of emergency physicians think that EDs are not the appropriate place for this intervention and are not included in their professional responsibilities.
The effect of nicotine dependence (ND) severity on smoking cessation has been shown in studies. Fagerström Test of Nicotine Dependence (FTND) developed by Fagerström et al. is a widely used tool to measure the ND level of individuals. The Turkish validity and reliability study of the test was conducted by Uysal et al. In the approach to smoking cessation, ND level comes to the forefront in determining personalized intervention strategies. At high levels of addiction, nicotine replacement therapy or pharmacologic support is recommended because the physical and psychological dependence of individuals is more intense. In these cases, motivational counseling and regular follow-up are necessary during the cessation process. At moderate levels of addiction, nicotine replacement products or behavioral therapies are usually recommended, while less pharmacological intervention may be required. At low levels of addiction, behavioral support and counseling may be sufficient for smoking cessation. Pharmacologic treatment is usually not needed in these individuals, but education and awareness-raising methods that support smoking cessation can be used. Intervention with strategies appropriate to the level of ND is a crucial factor in increasing the success of smoking cessation.
When determining the assistance method in individuals who want to quit smoking; WHO recommends five major steps (5A) in smoking cessation treatment. In practice, the "Ask, Advise, Assess, Assist, Arrange" approach is an evidence-based smoking cessation model that has been developed to provide effective interventions in a short time, especially in busy working environments.
This study aimed to examine the effects of short structured interviews with patients who presented to the ED due to ARI on smoking cessation behavior and to follow up for one month. It is aimed to evaluate the applicability of smoking cessation interventions on those with ARI in EDs.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active smokers who attend the emergency depertment with acute respiratory infections | – | Behavioral: Smoking cessation support that World Health Organization (WHO) 5A model (Ask, Advise, Assess, Assist, Arrange). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 20,928 patients presented to the ED during the specified period and 2,018 of these patients were evaluated with acute respiratory complaints diagnosed with ARI. Of the patients admitted with ARI, 541 reported active smoking. Finally, 288 participants were accepted for the study.
Key inclusion criteria (1 listed)
- Patients who were active smokers and admitted to the emergency department with acute respiratory system complaints.
Key exclusion criteria (1 listed)
- Exclusion criteria included individuals under 18 years of age, ASA class III-IV, pregnancy or breastfeeding, communication difficulties such as language barrier or cognitive impairment, psychotic behaviors or history of psychiatric treatment, and initiation of smoking cessation treatment.
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 |
|---|---|---|
| Smoking cessation support that World Health Organization (WHO) 5A model (Ask, Advise, Assess, Assist, Arrange).Smoking cessation support that World Health Organization (WHO) 5A model (Ask, Advise, Assess, Assist, Arrange). | Behavioural | Active smokers who attend the emergency depertment with acute respiratory infections |
Primary outcome
Smoking cessation success on acute respiratory infections patients based on FTND score
Time frame: Two periods as first week after intervention and first month after intervention.
Examine the effects of short structured interviews with patients who presented to the ED due to ARI on smoking cessation behavior. It is aimed to evaluate the applicability of smoking cessation interventions on those with ARI in EDs.
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 11 Apr 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Emergency Department Visit, run by Seda Oğuz.
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 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Smoking cessation success on acute respiratory infections patients based on FTND score (time frame: Two periods as first week after intervention and first month after intervention.). 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 11 Apr 2025.