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| Name | Class |
|---|---|
| Hamad Medical Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Active Comparator | 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). |
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| Intervention arm | Experimental | 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. The sessions will be set at a date and time that is convenient for both the pharmacist and the participant. The pharmacist will deliver the program at a time different from his or her pharmacy duty regular time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist delivered smoking cessation program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Self-reported 30 Day Smoking Abstinence | Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days | 3 months |
| Self-reported Continuous Abstinence at 3 Months | Self-reported continuous abstinence defined as having smoked no cigarettes since quit day | 3 months |
| Self-reported 7-day Point Prevalence Abstinence | Defined as having smoked no cigarettes for the previous 7 days | 6 months |
| Self-reported 30-day Point Prevalence Abstinence | Defined as having smoked no cigarettes in the last 30 days | 6 months |
| Self-reported Continuous Abstinence | Defined as having smoked no cigarettes since quit day | 6 months |
| Self-reported 7-day Point Prevalence Abstinence | Defined as having smoked no cigarettes for the previous 7 days | 12 months |
| Self-reported 30-day Point Prevalence Abstinence |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life | Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters | 6 month |
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Eligible participants are:
Exclusion criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Maguy S El Hajj, PharmD | Qatar University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Health Corporation (PHC) pharmacies | Doha | Qatar | ||||
| Qatar Petroleum pharmacies |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28219367 | Derived | El Hajj MS, Kheir N, Al Mulla AM, Shami R, Fanous N, Mahfoud ZR. Effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: a randomized controlled trial. BMC Public Health. 2017 Feb 20;17(1):215. doi: 10.1186/s12889-017-4103-4. | |
| 25885807 | Derived | El Hajj MS, Kheir N, Al Mulla AM, Al-Badriyeh D, Al Kaddour A, Mahfoud ZR, Salehi M, Fanous N. Assessing the effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial. Trials. 2015 Feb 26;16:65. doi: 10.1186/s13063-015-0570-z. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 Month Outcome Measure |
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| 6 Month Outcome Measure |
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| 12 Month Outcome Measure |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 3 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Blood pressure | Cardiac disorders | Non-systematic Assessment | Elevated Blood pressure due to nicotine replacement therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maguy El Hajj | Qatar University College of Pharmacy | 0097444035577 | maguyh@qu.edu.qa |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Control arm (i.e: regular care) | Other | 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). |
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Defined as having smoked no cigarettes in the last 30 days |
| 12 months |
| Self-reported Continuous Abstinence | Defined as having smoked no cigarettes since quit day at 12 months | 12 months |
| Objective Smoking Abstinence | Smoking abstinence as objectively verified by the CO exhaled test at 12 months | 12 months |
| Doha |
| Qatar |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Nationality | Count of Participants | Participants |
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| 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. |
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| 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 | Posted | Count of Participants | Participants | 3 months |
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| Primary | Self-reported Continuous Abstinence at 3 Months | Self-reported continuous abstinence defined as having smoked no cigarettes since quit day | Posted | Count of Participants | Participants | 3 months |
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| Primary | Self-reported 7-day Point Prevalence Abstinence | Defined as having smoked no cigarettes for the previous 7 days | Posted | Count of Participants | Participants | 6 months |
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| Primary | Self-reported 30-day Point Prevalence Abstinence | Defined as having smoked no cigarettes in the last 30 days | Posted | Count of Participants | Participants | 6 months |
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| Primary | Self-reported Continuous Abstinence | Defined as having smoked no cigarettes since quit day | Posted | Count of Participants | Participants | 6 months |
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| Primary | Self-reported 7-day Point Prevalence Abstinence | Defined as having smoked no cigarettes for the previous 7 days | Posted | Count of Participants | Participants | 12 months |
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| Primary | Self-reported 30-day Point Prevalence Abstinence | Defined as having smoked no cigarettes in the last 30 days | Posted | Count of Participants | Participants | 12 months |
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| Primary | Self-reported Continuous Abstinence | Defined as having smoked no cigarettes since quit day at 12 months | Posted | Number | participants | 12 months |
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| Primary | Objective Smoking Abstinence | Smoking abstinence as objectively verified by the CO exhaled test at 12 months | Posted | Count of Participants | Participants | 12 months |
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| 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 | Unfortunately patients didnt return at 6 months to fill the QOL questionnaire this is why we dont have data to report on this measure | Posted | 6 month |
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| 0 |
| 147 |
| 0 |
| 147 |
| 0 |
| 147 |
| EG001 | 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. | 0 | 167 | 0 | 167 | 2 | 167 |
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