NCT02123329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 2, 2018

Completed
Last Updated

January 2, 2018

Status Verified

June 1, 2017

Enrollment Period

2.8 years

First QC Date

April 20, 2014

Results QC Date

July 24, 2016

Last Update Submit

June 1, 2017

Conditions

Smoking Cessation

Keywords

QatarPharmacyPharmacistSmoking cessation

Outcome Measures

Primary Outcomes (10)

  • 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

    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

Secondary Outcomes (1)

  • Health Related Quality of Life

    6 month

Study Arms (2)

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).

Other: Control arm (i.e: regular care)

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.

Behavioral: Pharmacist delivered smoking cessation program

Interventions

Pharmacist delivered smoking cessation programBEHAVIORAL

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

Also known as: Participants 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.
Intervention arm
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).

Control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Primary Health Corporation (PHC) pharmacies

Doha, Qatar

Location

Qatar Petroleum pharmacies

Doha, Qatar

Location

Related Publications (2)

  • 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.

    PMID: 28219367DERIVED

  • 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.

    PMID: 25885807DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Dr. Maguy El Hajj
Organization
Qatar University College of Pharmacy
maguyh@qu.edu.qa
0097444035577

Study Officials

  • Maguy S El Hajj, PharmD

    Qatar University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Chair/ Clinical Pharmacy and Practice Section

Study Record Dates

First Submitted

April 20, 2014

First Posted

April 25, 2014

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

January 2, 2018

Results First Posted

January 2, 2018

Record last verified: 2017-06

Locations

QA(2)