Comparison of the effectiveness of telephone based smoking cessation program and hospital smoking cessation program in smoking cessation in patients with coronary artery disease
evaluation of the efficacy of telephone based smoking cessation program in patients with coronary artery disease.
Design
This study will be conducted as a clinical trial study.
Two hundred smokers with coronary artery disease admitted to Tehran Heart Center Hospital will be included in the study.
Patients will be divided into intervention and control groups.
Settings and conduct
This study will be conducted as a randomized clinical trial. 200 smokers with coronary artery disease in Tehran Heart Center Hospital will be included in the study. Information about demographic variables and variables related to smoking cessation will be collected by questionnaire. Patients will be randomly divided into intervention and control groups. The intervention group will have a smoking cessation training session with telephone counseling. After 6 months of discharge, smoking cessation will be recorded.
Participants/Inclusion and exclusion criteria
Smokers with coronary artery disease who are admitted to Tehran Heart Center Hospital
Intervention groups
In the control group short-term hospital smoking cessation consisting of a one-hour training session on prevention of cardiac disease risk factors conducted in a group by a nurse and recommendation to use Nicotine Replacement Therapy (NRT).
In the intervention group, in addition to all the measures performed in the control group, a long-term smoking cessation training program will be implemented which includes the following sections:
After discharge, patients will receive five 10-minute telephone consultations (2 days, 1 week, 3 weeks, 3 months, and 5 months after discharge), which will be conducted by a trained nurse.
Main outcome variables
Number of cigarettes consumed per day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190119042417N1
Registration date:2020-03-03, 1398/12/13
Registration timing:registered_while_recruiting
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Alireza Shamsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1357
Email address
ar.shamsi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of telephone based smoking cessation program and hospital smoking cessation program in smoking cessation in patients with coronary artery disease
Public title
The effect of telephone based smoking cessation program in patients with coronary artery disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consume at least five cigarettes daily for at least one month before admission
Suffering from coronary artery disease
Attempted to quit smoking following coronary artery disease
Patient consent for inclusion in the study
Exclusion criteria:
Language problems that the patient is unable to complete the questionnaire
Unstable clinical condition
Patients with dementia (according to history)
Patients with delirium (lack of awareness to time, place, or person at interview time)
patient that cannot be reached by telephone for follow up
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals with inclusion criteria will be randomly assigned to one of two study groups after obtaining informed consent. Permuted Block Stratified Randomization with 2, 4, 6, and 8 random blocks with software of the same name (Block Stratified Randomization) will be used to generate the random list. To avoid selection bias, and to comply with allocation concealment the random list will be provided to the individual outside the sampling process.
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
Ethics committee of Shahid Beheshti University of medical sciences
Street address
Shahid Beheshti university of medical siences, Aarabi Ave, Yaman Ave, Chamran St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.SBMU.MSP.REC.1398. 673
Health conditions studied
1
Description of health condition studied
coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
smoking cessation
Timepoint
at baseline and after 6 months
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
One hour training course on heart disease risk factors and the long-term smoking cessation training program will be implemented by telephone counseling, which includes the following sections: An interview session including diagnostic interview and motivational interview will be conducted by a psychiatric resident. In this interview, the patient's attitude toward smoking, the consequences of smoking in cardiac patients and the benefits of quitting smoking will be assessed. The motivation to quit smoking will be assessed. Benefits of smoking cessation (In particular: five-year mortality reduction to half, reduction in surgical wound healing time, and reduction in pulmonary complications) And the risks of continued smoking (in particular: the increased likelihood of re-operation due to vessel congestion, the prolongation of hospital stay) will be explained to the patient. Afterwards the stages of smoking cessation and how to evaluate the patient after discharge will be explained. Patients will receive five 10-minute telephone consultations (2 days, 1 week, 3 weeks, 3 months and 5 months after discharge), which will be conducted by a trained nurse. In these consultations, the patient will be asked about whether or not to stop smoking. If the patient continues to smoke, the patient will be warned about the risk of heart disease and the dangers of continuing to smoke, and positive consequences of smoking cessation will be reminded if patient stops smoking.
Category
Treatment - Other
2
Description
Control group: One-hour training class on heart disease risk factors routinely taught to all hospitalized patients.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center Hospital
Full name of responsible person
Majid Sadeghian
Street address
North kargar St, Tehran Heart Center Hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 8802 9600
Email
sadeghian_5@yahoo.com
Web page address
http://thc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Aarabi Ave, Yaman Ave, Chamran St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2387
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Sadeghian
Position
psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No 34, Kashfian Ave, Sheykhbahai St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 8803 8050
Email
sadeghian_5@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Shamsi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 8803 8050
Email
ar.shamsi@sbmu.ac.ir
Web page address
http://isid.research.ac.ir/AliReza_Shamsi
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Sadeghian
Position
psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No 34, Kashfian Ave, Sheykhbahai St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 8803 8050
Email
sadeghian_5@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
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 study protocol, informed consent form, participant data file, and study report will be shared.
When the data will become available and for how long
12 to 24 months after publication of study results.
To whom data/document is available
Researchers working in academic and scientific institutions