Smoking Cessation
Conditions
Keywords
Qatar, Pharmacy, Pharmacist, Smoking cessation
Brief summary
Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths. Health care providers are in an ideal position to encourage smoking cessation. Pharmacists are the most accessible health care providers and are uniquely situated to initiate behavior change among patients. Many western studies have shown that pharmacists can be successful in helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the effect of a structured smoking cessation program delivered by trained ambulatory pharmacists in Qatar. A prospective, randomized, controlled trial will be conducted at 8 ambulatory pharmacies in Qatar. Participants will be randomly assigned to receive a 4-session face-to-face structured patient-specific smoking cessation program conducted by the pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by the pharmacist. Both groups will be offered nicotine therapy if feasible. The primary outcome of smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months. If proven to be effective, this smoking cessation program will be considered as a model that Qatar and the region can apply to decrease smoking burden.
Interventions
BEHAVIORALPharmacist delivered smoking cessation program
The first session will be time-intensive taking around 30 minutes. In this session, the study pharmacist will facilitate the participant's preparation to quit. The participant will select a quit date within the next 2-4 weeks. The pharmacist will discuss with the participant the benefits of smoking cessation and will provide him or her with tailored behavioral and lifestyle strategies. To prevent nicotine withdrawal symptoms, the participant will be offered nicotine replacement therapy (NRT) The first follow-up session will be scheduled after 1 week of the participant's quit day and will take around 20 minutes. In this session, the pharmacist will determine the participant's smoking status and assess the NRT tolerability. • If the participant fails to quit smoking, the pharmacist will carefully review the participant's experience during the attempt to quit and will work through the identified problems
OTHERControl arm (i.e: regular care)
Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).
Sponsors
Hamad Medical Corporation
Qatar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants are: * patients aged 18 years and older who currently smoke one or more cigarettes daily for 7 days, are motivated to quit i.e.: in the preparation stage of the stage-of-change model, able to communicate in Arabic or English and are willing and capable of attending the scheduled sessions at the study pharmacies.
Exclusion criteria
are: * use of other nicotine or tobacco products * current use or use in the last 30 days of quit smoking aids or medications * plan to leave Qatar in the next 12 months * presence of any major medical condition that would prevent use of the nicotine replacement therapy including hypersensitivity to the products, history of or recent myocardial infarction, life-threatening arrhythmias, severe or worsening angina, uncontrolled hypertension and temporomandibular joint disease (in case of nicotine gum) * pregnancy * psychiatric illness or other debilitating condition that would interfere with participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Continuous Abstinence at 3 Months | 3 months | Self-reported continuous abstinence defined as having smoked no cigarettes since quit day |
| Self-reported 7-day Point Prevalence Abstinence | 3 months | Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days |
| Self-reported 30 Day Smoking Abstinence | 3 months | Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days |
| Objective Smoking Abstinence | 12 months | Smoking abstinence as objectively verified by the CO exhaled test at 12 months |
| Self-reported 30-day Point Prevalence Abstinence | 6 months | Defined as having smoked no cigarettes in the last 30 days |
| Self-reported Continuous Abstinence | 6 months | Defined as having smoked no cigarettes since quit day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life | 6 month | Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters |
Countries
Qatar
Participant flow
Recruitment details
Between February 2013 and December 2014, the study pharmacists assessed 450 smokers for eligibility in the study. Of them, 361 (80.2%) met the study inclusion criteria. A total of 314 cigarette smokers consented to enroll in the study and were randomized into one of two study groups
Participants by arm
| Arm | Count |
|---|---|
| Control Arm Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).
Control arm (i.e: regular care): Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT). | 147 |
| Intervention Arm Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy. | 167 |
| Total | 314 |
Baseline characteristics
| Characteristic | Control Arm | Intervention Arm | Total |
|---|---|---|---|
| Age, Customized 18-29 years | 33 Participants | 40 Participants | 73 Participants |
| Age, Customized 30-39 years | 55 Participants | 53 Participants | 108 Participants |
| Age, Customized 40-49 years | 27 Participants | 46 Participants | 73 Participants |
| Age, Customized 50 years and above | 27 Participants | 24 Participants | 51 Participants |
| Age, Customized Unknown | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Egypt | 49 Participants | 41 Participants | 90 Participants |
| Race/Ethnicity, Customized Other countries | 60 Participants | 96 Participants | 156 Participants |
| Race/Ethnicity, Customized Qatar | 36 Participants | 25 Participants | 61 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 143 Participants | 164 Participants | 307 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 147 | 0 / 167 |
| other Total, other adverse events | 0 / 147 | 2 / 167 |
| serious Total, serious adverse events | 0 / 147 | 0 / 167 |
Outcome results
Primary
Objective Smoking Abstinence
Smoking abstinence as objectively verified by the CO exhaled test at 12 months
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Objective Smoking Abstinence | 2 Participants |
| Intervention Arm | Objective Smoking Abstinence | 6 Participants |
Primary
Self-reported 30-day Point Prevalence Abstinence
Defined as having smoked no cigarettes in the last 30 days
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Self-reported 30-day Point Prevalence Abstinence | 20 Participants |
| Intervention Arm | Self-reported 30-day Point Prevalence Abstinence | 27 Participants |
Primary
Self-reported 30-day Point Prevalence Abstinence
Defined as having smoked no cigarettes in the last 30 days
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Self-reported 30-day Point Prevalence Abstinence | 14 Participants |
| Intervention Arm | Self-reported 30-day Point Prevalence Abstinence | 21 Participants |
Primary
Self-reported 30 Day Smoking Abstinence
Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Self-reported 30 Day Smoking Abstinence | 22 Participants |
| Intervention Arm | Self-reported 30 Day Smoking Abstinence | 27 Participants |
Primary
Self-reported 7-day Point Prevalence Abstinence
Defined as having smoked no cigarettes for the previous 7 days
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Self-reported 7-day Point Prevalence Abstinence | 21 Participants |
| Intervention Arm | Self-reported 7-day Point Prevalence Abstinence | 28 Participants |
Primary
Self-reported 7-day Point Prevalence Abstinence
Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Self-reported 7-day Point Prevalence Abstinence | 26 Participants |
| Intervention Arm | Self-reported 7-day Point Prevalence Abstinence | 31 Participants |
Primary
Self-reported 7-day Point Prevalence Abstinence
Defined as having smoked no cigarettes for the previous 7 days
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Self-reported 7-day Point Prevalence Abstinence | 14 Participants |
| Intervention Arm | Self-reported 7-day Point Prevalence Abstinence | 21 Participants |
Primary
Self-reported Continuous Abstinence
Defined as having smoked no cigarettes since quit day
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Self-reported Continuous Abstinence | 20 Participants |
| Intervention Arm | Self-reported Continuous Abstinence | 23 Participants |
Primary
Self-reported Continuous Abstinence
Defined as having smoked no cigarettes since quit day at 12 months
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Self-reported Continuous Abstinence | 14 participants |
| Intervention Arm | Self-reported Continuous Abstinence | 21 participants |
Primary
Self-reported Continuous Abstinence at 3 Months
Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Self-reported Continuous Abstinence at 3 Months | 21 Participants |
| Intervention Arm | Self-reported Continuous Abstinence at 3 Months | 25 Participants |
Secondary
Health Related Quality of Life
Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
Time frame: 6 month
Population: Unfortunately patients didnt return at 6 months to fill the QOL questionnaire this is why we dont have data to report on this measure
| Arm | Measure | Value |
|---|---|---|
| Control Arm | Health Related Quality of Life | 0 |
| Intervention Arm | Health Related Quality of Life | 0 |