Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar

Smoking Cessation Clinical Trial

Official title:

Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123329
• Other study ID #: NPRP 4 - 716 - 3 - 203
• Status: Completed
• Phase: N/A
• First received: April 20, 2014
• Last updated: June 1, 2017
• Start date: February 2013
• Est. completion date: June 2016

Study information

• Verified date: June 2017
• Source: Qatar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Pharmacist 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

Other:
• 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).

Locations

Country	Name	City	State
Qatar	Primary Health Corporation (PHC) pharmacies	Doha
Qatar	Qatar Petroleum pharmacies	Doha

Sponsors (2)

Lead Sponsor	Collaborator
Qatar University	Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	3 months
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	3 months
Primary	Self-reported Continuous Abstinence at 3 Months	Self-reported continuous abstinence defined as having smoked no cigarettes since quit day	3 months
Primary	Self-reported 7-day Point Prevalence Abstinence	Defined as having smoked no cigarettes for the previous 7 days	6 months
Primary	Self-reported 30-day Point Prevalence Abstinence	Defined as having smoked no cigarettes in the last 30 days	6 months
Primary	Self-reported Continuous Abstinence	Defined as having smoked no cigarettes since quit day	6 months
Primary	Self-reported 7-day Point Prevalence Abstinence	Defined as having smoked no cigarettes for the previous 7 days	12 months
Primary	Self-reported 30-day Point Prevalence Abstinence	Defined as having smoked no cigarettes in the last 30 days	12 months
Primary	Self-reported Continuous Abstinence	Defined as having smoked no cigarettes since quit day at 12 months	12 months
Primary	Objective Smoking Abstinence	Smoking abstinence as objectively verified by the CO exhaled test at 12 months	12 months
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	6 month