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

Primary Purpose

Tobacco Cessation, Asthma COPD, Bronchiectasis Adult

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Immediate smoking cessation support
Sponsored by
Recep Tayyip Erdogan University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Cessation focused on measuring tobacco cessation, asthma, COPD, bronchiectasis, immediate cessation support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being age 18 years and over, Having diagnoses of asthma and/or COPD and/or bronchiectasis for at least 6 months, Applying to the chest diseases outpatient clinics, Being an current smoker, Those who agree to participate in the study, Patients who can be reached by phone calls at 1 week and 3 months after randomization. Exclusion Criteria: Those with active psychiatric disorders Patients with impaired cognitive functions.

Sites / Locations

  • Recep Tayyip Erdoğan University, Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Routine support/care arm

Immediate support arm

Arm Description

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.

Those randomized to this group will have an immediate appointment at the smoking cessation outpatient clinic in addition to the brief smoking cessation intervention.

Outcomes

Primary Outcome Measures

Quit rate of both study arms
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.

Secondary Outcome Measures

Smoking cessation outpatient clinic application rate of both study arms
The admission status to smoking cessation outpatient clinics of both arms will be evaluated: admitted at least once or never admitted.

Full Information

First Posted
February 11, 2023
Last Updated
March 1, 2023
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Collaborators
Turkish Thoracic Society
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1. Study Identification

Unique Protocol Identification Number
NCT05764343
Brief Title
The Effect of Immediate Smoking Cessation Interventions for Smokers With Chronic Airway Diseases
Official Title
Investigation of the Effectiveness of Immediate Smoking Cessation Interventions During Routine Outpatient Service in Current Smoker Chronic Airway Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Collaborators
Turkish Thoracic Society

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Cessation, Asthma COPD, Bronchiectasis Adult
Keywords
tobacco cessation, asthma, COPD, bronchiectasis, immediate cessation support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine support/care arm
Arm Type
No Intervention
Arm Description
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.
Arm Title
Immediate support arm
Arm Type
Active Comparator
Arm Description
Those randomized to this group will have an immediate appointment at the smoking cessation outpatient clinic in addition to the brief smoking cessation intervention.
Intervention Type
Other
Intervention Name(s)
Immediate smoking cessation support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quit rate of both study arms
Description
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.
Time Frame
At third month of randomization
Secondary Outcome Measure Information:
Title
Smoking cessation outpatient clinic application rate of both study arms
Description
The admission status to smoking cessation outpatient clinics of both arms will be evaluated: admitted at least once or never admitted.
Time Frame
At third month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being age 18 years and over, Having diagnoses of asthma and/or COPD and/or bronchiectasis for at least 6 months, Applying to the chest diseases outpatient clinics, Being an current smoker, Those who agree to participate in the study, Patients who can be reached by phone calls at 1 week and 3 months after randomization. Exclusion Criteria: Those with active psychiatric disorders Patients with impaired cognitive functions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilek Karadoğan, Assoc Prof
Phone
00905063512295
Email
dilek.karadogan@erdogan.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Karadoğan
Organizational Affiliation
Recep Tayyip Erdogan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Recep Tayyip Erdoğan University, Training and Research Hospital
City
Rize
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dilek Karadoğan
First Name & Middle Initial & Last Name & Degree
Dilek Karadoğan
First Name & Middle Initial & Last Name & Degree
İlknur Kaya
First Name & Middle Initial & Last Name & Degree
Merve Yumrukuz Şenel
First Name & Middle Initial & Last Name & Degree
Neslihan Köse Kabil
First Name & Middle Initial & Last Name & Degree
Siahmet Atlı
First Name & Middle Initial & Last Name & Degree
Merve Erçelik
First Name & Middle Initial & Last Name & Degree
Feride Marım
First Name & Middle Initial & Last Name & Degree
Aycan Yüksel
First Name & Middle Initial & Last Name & Degree
Burcu Yalçın
First Name & Middle Initial & Last Name & Degree
Tahsin Gökhan Telatar
First Name & Middle Initial & Last Name & Degree
Metin Akgün

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25882805
Citation
Jimenez-Ruiz CA, Andreas S, Lewis KE, Tonnesen P, van Schayck CP, Hajek P, Tonstad S, Dautzenberg B, Fletcher M, Masefield S, Powell P, Hering T, Nardini S, Tonia T, Gratziou C. Statement on smoking cessation in COPD and other pulmonary diseases and in smokers with comorbidities who find it difficult to quit. Eur Respir J. 2015 Jul;46(1):61-79. doi: 10.1183/09031936.00092614. Epub 2015 Apr 16.
Results Reference
result
PubMed Identifier
31582917
Citation
Karadogan D, Onal O, Kanbay Y. How does reimbursement status affect smoking cessation interventions? A real-life experience from the Eastern Black Sea region of Turkey. Tob Induc Dis. 2019 Jan 22;17:05. doi: 10.18332/tid/100412. eCollection 2019. Erratum In: Tob Induc Dis. 2019 Sep 13;17:67.
Results Reference
result
PubMed Identifier
35932889
Citation
Williams PJ, Philip KEJ, Gill NK, Flannery D, Buttery S, Bartlett EC, Devaraj A, Kemp SV, Addis J, Derbyshire J, Chen M, Morris K, Laverty AA, Hopkinson NS. Immediate, Remote Smoking Cessation Intervention in Participants Undergoing a Targeted Lung Health Check: Quit Smoking Lung Health Intervention Trial, a Randomized Controlled Trial. Chest. 2023 Feb;163(2):455-463. doi: 10.1016/j.chest.2022.06.048. Epub 2022 Aug 4.
Results Reference
result
PubMed Identifier
35121633
Citation
Buttery SC, Williams P, Mweseli R, Philip KEJ, Sadaka A, Bartlett EJ, Devaraj A, Kemp S, Addis J, Derbyshire J, Chen M, Morris K, Laverty A, Hopkinson NS. Immediate smoking cessation support versus usual care in smokers attending a targeted lung health check: the QuLIT trial. BMJ Open Respir Res. 2022 Feb;9(1):e001030. doi: 10.1136/bmjresp-2021-001030.
Results Reference
result

Learn more about this trial

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

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