Clinical trial NCT02123329: Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
Official title: Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Qatar
Pharmacy
Pharmacist
Smoking cessation
Lead sponsor: Qatar University
Sponsor class: OTHER
Collaborators: name: Hamad Medical Corporation
First posted: 2014-04-25
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Self-reported 7-day Point Prevalence Abstinence
timeFrame: 3 months
measure: Self-reported 30 Day Smoking Abstinence
timeFrame: 3 months
measure: Self-reported Continuous Abstinence at 3 Months
timeFrame: 3 months
measure: Self-reported 7-day Point Prevalence Abstinence
timeFrame: 6 months
measure: Self-reported 30-day Point Prevalence Abstinence
timeFrame: 6 months
measure: Self-reported Continuous Abstinence
timeFrame: 6 months
measure: Self-reported 7-day Point Prevalence Abstinence
timeFrame: 12 months
measure: Self-reported 30-day Point Prevalence Abstinence
timeFrame: 12 months
measure: Self-reported Continuous Abstinence
timeFrame: 12 months
measure: Objective Smoking Abstinence
timeFrame: 12 months
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: 6 month
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Primary Health Corporation (PHC) pharmacies
city: Doha
country: Qatar
facility: Qatar Petroleum pharmacies
Study officials:
affiliation: Qatar University
name: Maguy S El Hajj, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.