To determine the dominant smoking trigger & the effects of a tailored nursing intervention on controlling such trigger.
Design
A quasi-experimental comparative design was employed to achieve the aforementioned objectives. 64 subjects will be assigned to Join the study group. The rest will be in the control group. The total sample size would be 128 subjects.
Settings and conduct
A 128 smokers with Non-communicable Chronic Diseases, who were visiting outpatient clinic in one major teaching hospital at Baghdad City. Study subjects were recruited when they were seeking the follow-up of their health problems and prescriptions refilling.The simple randomization procedure would involve throwing a dice (eg, below & equal to 3 = control, over 3 = treatment). No allocation concealment will be carried out.
Participants/Inclusion and exclusion criteria
Inclusion: *Consent & compliance with all aspects of the study protocol, methods, providing data during follow-up phase.*Contact male & female patients, who are 18-70 years old at the time of data collection phase
Exclusion:*Involvement with any other ongoing studies.
*Medically diagnosed with psycho-mental diseases
*Morbidly ill subjects, whereas their physical & mental capacity are impaired
Intervention groups
Intervention group: The starting point of the intervention phase will start by asking the subjects to respond to “why do you smoke” questionnaire (American Lung Association, 1993). This mandatory step will help in categorizing the subjects according to their smoking trigger. Intervention group subjects will be armed with orally & in a written form of simple, yet specific instructions to enable them managing their dominant smoking trigger. The intervention group will be contacted after 14 days to see the influence of the given instruction on their smoking status.
Main outcome variables
Quitting or Reducing the Smoked Tobacco Cigarettes
General information
Reason for update
Acronym
Targeting Smoking Triggers Trial(TSTT)
IRCT registration information
IRCT registration number:IRCT20190809044485N2
Registration date:2020-04-01, 1399/01/13
Registration timing:retrospective
Last update:2020-04-01, 1399/01/13
Update count:0
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Sadeq AL-Fayyadh
Name of organization / entity
University of Baghdad, College of Nursing
Country
Iraq
Phone
+964 1 521 1494
Email address
s.al-fayyadh@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-07, 1397/08/16
Expected recruitment end date
2019-01-27, 1397/11/07
Actual recruitment start date
2018-11-07, 1397/08/16
Actual recruitment end date
2019-01-27, 1397/11/07
Trial completion date
2019-01-27, 1397/11/07
Scientific title
Influence of A Tailored Nurse-Led Intervention on Controlling Tobacco Smoking
Public title
Targeting Smoking Triggers: A Tailored Nurse-led Intervention for Controlling Tobacco Smoking
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent & compliance with all aspects of the study protocol, methods, providing data during follow-up phase
Contact male & female patients, who are 18-70 years old at the time of data collection phase
Exclusion criteria:
Involvement with any other ongoing studies.
Medically diagnosed with psycho-mental diseases
Morbidly ill subjects, whereas their physical & mental capacity are impaired
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
750
Actual sample size reached:
128
Randomization (investigator's opinion)
Randomized
Randomization description
In order to maintain a transparent & scientific-based randomization process, simple randomization will be used in assigning participants (individuals: Active smokers), to treatment & control groups, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve throwing a dice (eg, below & equal to 3 = control, over 3 = treatment). No allocation concealment will be carried out.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Approval date
2017-12-21, 1396/09/30
Ethics committee reference number
2395
Health conditions studied
1
Description of health condition studied
Tobacco Cigarettes Smoking Dependence
ICD-10 code
F17.21
ICD-10 code description
Nicotine dependence, cigarettes
Primary outcomes
1
Description
Smoking Tobacco Cigarettes (Quitting or Reducing)
Timepoint
Subjects response to the educational intervention will be within two weeks of the first meeting to examine the effectiveness of the intervention on smoking habit
Method of measurement
Self-report of smoking status after being exposed to the educational intervention
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The starting point of the intervention phase will start by asking the subjects to respond to “why do you smoke” questionnaire (American Lung Association, 1993). This mandatory step will help in categorizing the subjects according to their smoking trigger. Intervention group subjects will be armed with orally & in a written form of simple, yet specific instructions to enable them managing their dominant smoking trigger. The intervention group will be contacted after 14 days to see the influence of the given instruction on their smoking status.
Category
Lifestyle
2
Description
Control group: In order to be matched with subjects in the intervention group, control group subjects smoking dominant trigger will be determined. No instructions will be given to them during the study course.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
The outpatient clinic of the Baghdad Teaching Hospital at Medical City Complex
Full name of responsible person
Sadeq AL-Fayyadh
Street address
Bab AL-Muadum Medical City Complex
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor Iqbal Ghanim Muala, PhD. Dean
Street address
Bab AL-Muadum campus
City
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Sadeq AL-Fayyadh
Position
Faculty member-An Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Al Karkh, Ajnadine neighborhood, House No 3, Street No 62, Section No 863
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Fax
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Sadeq AL-Fayyadh
Position
Faculty member-An Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Al Karkh, Ajnadine neighborhood, House No 3, Street No 62, Section No 863
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Fax
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Sadeq AL-Fayyadh
Position
Faculty member-An Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Al Karkh, Ajnadine neighborhood, House No 3, Street No 62, Section No 863
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Fax
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution.
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: s.al-fayyadh@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.