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

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ClinicalTrials.gov Identifier: NCT02123329
Recruitment Status : Completed
First Posted : April 25, 2014
Results First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Collaborator:
Hamad Medical Corporation
Information provided by (Responsible Party):
Dr. Maguy El Hajj, Qatar University

Tracking Information
First Submitted Date  ICMJE April 20, 2014
First Posted Date  ICMJE April 25, 2014
Results First Submitted Date  ICMJE July 24, 2016
Results First Posted Date  ICMJE January 2, 2018
Last Update Posted Date January 2, 2018
Study Start Date  ICMJE February 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
  • Self-reported 7-day Point Prevalence Abstinence [ Time Frame: 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 [ Time Frame: 3 months ]
    Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
  • Self-reported Continuous Abstinence at 3 Months [ Time Frame: 3 months ]
    Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
  • Self-reported 7-day Point Prevalence Abstinence [ Time Frame: 6 months ]
    Defined as having smoked no cigarettes for the previous 7 days
  • Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 6 months ]
    Defined as having smoked no cigarettes in the last 30 days
  • Self-reported Continuous Abstinence [ Time Frame: 6 months ]
    Defined as having smoked no cigarettes since quit day
  • Self-reported 7-day Point Prevalence Abstinence [ Time Frame: 12 months ]
    Defined as having smoked no cigarettes for the previous 7 days
  • Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 12 months ]
    Defined as having smoked no cigarettes in the last 30 days
  • Self-reported Continuous Abstinence [ Time Frame: 12 months ]
    Defined as having smoked no cigarettes since quit day at 12 months
  • Objective Smoking Abstinence [ Time Frame: 12 months ]
    Smoking abstinence as objectively verified by the CO exhaled test at 12 months
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
  • Self-reported 7-day Point Prevalence Abstinence [ Time Frame: 3 months ]
    defined as having smoked no cigarettes for the previous 7 days at 3 months
  • Self-reported 30-day point prevalence abstinence [ Time Frame: 3 months ]
    Defined as having smoked no cigarettes in the last 30 days at 3 months
  • Self-reported continuous abstinence [ Time Frame: 3 months ]
    Defined as having smoked no cigarettes since quit day at 3 months
  • Objective Smoking Abstinence [ Time Frame: 12 months ]
    Smoking abstinence as objectively verified by the CO exhaled test at 12 months
  • Self-reported 7-day Point Prevalence Abstinence [ Time Frame: 6 months ]
    defined as having smoked no cigarettes for the previous 7 days at 6 months
  • Self-reported 7-day Point Prevalence Abstinence [ Time Frame: 12 months ]
    defined as having smoked no cigarettes for the previous 7 days at 12 months
  • Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 6 months ]
    Defined as having smoked no cigarettes in the last 30 days at 6 months
  • Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 12 months ]
    Defined as having smoked no cigarettes in the last 30 days at 12 months
  • Self-reported Continuous Abstinence [ Time Frame: 6 months ]
    Defined as having smoked no cigarettes since quit day at 6 months
  • Self-reported Continuous Abstinence [ Time Frame: 12 months ]
    Defined as having smoked no cigarettes since quit day at 12 months
Change History Complete list of historical versions of study NCT02123329 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
Health Related Quality of Life [ Time Frame: 6 month ]
Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
Health Related Quality of Life [ Time Frame: at 6 months ]
Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
Official Title  ICMJE Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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 Name: 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.
  • 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).
Study Arms  ICMJE
  • Active Comparator: 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).
    Intervention: Other: Control arm (i.e: regular care)
  • Experimental: 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. 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.
    Intervention: Behavioral: Pharmacist delivered smoking cessation program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2017)
314
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2014)
250
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Qatar
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02123329
Other Study ID Numbers  ICMJE NPRP 4 - 716 - 3 - 203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Maguy El Hajj, Qatar University
Study Sponsor  ICMJE Qatar University
Collaborators  ICMJE Hamad Medical Corporation
Investigators  ICMJE
Principal Investigator: Maguy S El Hajj, PharmD Qatar University
PRS Account Qatar University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP