The Effect of Immediate Smoking Cessation Interventions for Smokers With Chronic Airway Diseases

March 1, 2023 updated by: Dilek KARADOĞAN, Recep Tayyip Erdogan University Training and Research Hospital

Investigation of the Effectiveness of Immediate Smoking Cessation Interventions During Routine Outpatient Service in Current Smoker Chronic Airway Disease Patients

Smoking cessation support is provided by smoking cessation outpatient clinics in our country. Smokers with chronic airway diseases can also apply to these services by making an appointment from quit lines. Quit rates of that group patients were found to be similar to the general population. In novel smoking cessation support approaches immediate cessation support is reported to be more effective than routine practice. The sample in these studies consists of individuals who applied for lung health screening programmes. There is no study in the literature examining the effect of this immediate support on patients with chronic airway diseases' quit success. Our aim with this study is to examine impact of immediate cessation support by getting an appointment to the same cessation clinic instantly on our sample's cessation success.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who are current smokers (who have smoked at least 100 cigarettes in their lifetime and still smoke daily or some days) will be randomized in a 1:1 ratio to the two arms in sequential order of presentation, after they have been identified and given written informed consent about the study. Demographic and clinical features will be filled. A brief smoking cessation intervention will be applied to one group and they will be recommended to apply to smoking cessation outpatient clinics by obtaining appointment from quit lines, as the way of current routine practice. Those randomized to the other group will have an immediate appointment at the smoking cessation outpatient clinic in addition to the brief smoking cessation intervention. Both patient groups will be called after 1 week by phone to inquire about their smoking cessation status and their application to smoking cessation outpatient clinics. Both groups will be called again in the 3rd month and their smoking cessation status, their application to smoking cessation outpatient clinics, and the duration/status of using pharmacological smoking cessation treatments will be questioned.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
      • Rize, Turkey
        • Recruiting
        • Recep Tayyip Erdoğan University, Training and Research Hospital
        • Contact:
          • Dilek Karadoğan
        • Principal Investigator:
          • Dilek Karadoğan
        • Sub-Investigator:
          • İlknur Kaya
        • Sub-Investigator:
          • Merve Yumrukuz Şenel
        • Sub-Investigator:
          • Neslihan Köse Kabil
        • Sub-Investigator:
          • Siahmet Atlı
        • Sub-Investigator:
          • Merve Erçelik
        • Sub-Investigator:
          • Feride Marım
        • Sub-Investigator:
          • Aycan Yüksel
        • Sub-Investigator:
          • Burcu Yalçın
        • Sub-Investigator:
          • Tahsin Gökhan Telatar
        • Sub-Investigator:
          • Metin Akgün

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

Description

Inclusion Criteria:

  1. Being age 18 years and over,
  2. Having diagnoses of asthma and/or COPD and/or bronchiectasis for at least 6 months,
  3. Applying to the chest diseases outpatient clinics,
  4. Being an current smoker,
  5. Those who agree to participate in the study,
  6. Patients who can be reached by phone calls at 1 week and 3 months after randomization.

Exclusion Criteria:

  1. Those with active psychiatric disorders
  2. Patients with impaired cognitive functions.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine support/care arm
As the followed routine implementation, this group will be given a brief smoking cessation intervention and will be recommended to apply to smoking cessation outpatient clinics by getting an appointment from quit services.
Active Comparator: Immediate support arm
Those randomized to this group will have an immediate appointment at the smoking cessation outpatient clinic in addition to the brief smoking cessation intervention.
Other: Immediate smoking cessation support
Smoker patients with chronic airway diseases (asthma and/or COPD and/or bronchiectasis) will be evaluated for the inclusion criteria. Afterwards they will be randomized as routine support arm (as the current procedure of the care) and immediate support arm (intensive brief cessation advices following by the immediate arrangement of the appointment from the same clinic's smoking cessation service). Both arms will be followed remotely at first week and third months of the randomization regarding their quit status as well as their use of evidence based cessation treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quit rate of both study arms
Time Frame: At third month of randomization
To compare the quit rate at third month of randomization in the both arms: intensive support arm compared to routine support arm. A quitter will be considered who have never smoked since the target quit day.
At third month of randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking cessation outpatient clinic application rate of both study arms
Time Frame: At third month
The admission status to smoking cessation outpatient clinics of both arms will be evaluated: admitted at least once or never admitted.
At third month

Collaborators and Investigators

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

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Collaborators

Turkish Thoracic Society

Investigators

  • Principal Investigator: Dilek Karadoğan, Recep Tayyip Erdogan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 15, 2022

Primary Completion (Anticipated)

June 15, 2023

Study Completion (Anticipated)

September 15, 2023

Study Registration Dates

First Submitted

February 11, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Estimate)

March 10, 2023

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKGG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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