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

• Sponsor: Qatar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02123329
• Collaborator: Hamad Medical Corporation (Industry)
• Enrollment: 314
• Locations: 2
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 157
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: Pharmacist delivered smoking cessation program; Other: Control arm (i.e: regular care)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 314 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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).	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).
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.	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 Names: 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.

Outcome Measures

Primary Outcome Measures

1. Self-reported 7-day Point Prevalence Abstinence [3 months]

   Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days

2. Self-reported 30 Day Smoking Abstinence [3 months]

   Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days

3. Self-reported Continuous Abstinence at 3 Months [3 months]

   Self-reported continuous abstinence defined as having smoked no cigarettes since quit day

4. Self-reported 7-day Point Prevalence Abstinence [6 months]

   Defined as having smoked no cigarettes for the previous 7 days

5. Self-reported 30-day Point Prevalence Abstinence [6 months]

   Defined as having smoked no cigarettes in the last 30 days

6. Self-reported Continuous Abstinence [6 months]

   Defined as having smoked no cigarettes since quit day

7. Self-reported 7-day Point Prevalence Abstinence [12 months]

   Defined as having smoked no cigarettes for the previous 7 days

8. Self-reported 30-day Point Prevalence Abstinence [12 months]

   Defined as having smoked no cigarettes in the last 30 days

9. Self-reported Continuous Abstinence [12 months]

   Defined as having smoked no cigarettes since quit day at 12 months

10. Objective Smoking Abstinence [12 months]

    Smoking abstinence as objectively verified by the CO exhaled test at 12 months

Secondary Outcome Measures

1. Health Related Quality of Life [6 month]

   Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary Health Corporation (PHC) pharmacies	Doha		Qatar
2	Qatar Petroleum pharmacies	Doha		Qatar

Sponsors and Collaborators

• Qatar University
• Hamad Medical Corporation

Investigators

• Principal Investigator: Maguy S El Hajj, PharmD, Qatar University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Maguy El Hajj, Assistant Professor and Chair/ Clinical Pharmacy and Practice Section, Qatar University
• ClinicalTrials.gov Identifier: NCT02123329
• Other Study ID Numbers: NPRP 4 - 716 - 3 - 203
• First Posted: Apr 25, 2014
• Last Update Posted: Jan 2, 2018
• Last Verified: Jun 1, 2017

• Keywords provided by Dr. Maguy El Hajj, Assistant Professor and Chair/ Clinical Pharmacy and Practice Section, Qatar University: Qatar; Pharmacy; Pharmacist; Smoking cessation

Study Results

Participant Flow

Recruitment Details	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

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Period Title: 3 Month Outcome Measure
STARTED	147	167
COMPLETED	98	101
NOT COMPLETED	49	66
Period Title: 3 Month Outcome Measure
STARTED	147	167
COMPLETED	99	100
NOT COMPLETED	48	67
Period Title: 3 Month Outcome Measure
STARTED	147	167
COMPLETED	83	88
NOT COMPLETED	64	79

Baseline Characteristics

Arm/Group Title	Control Arm	Intervention Arm	Total
Arm/Group Description	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).	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.	Total of all reporting groups
Overall Participants	147	167	314
Age, Customized (Count of Participants)
18-29 years	33 22.4%	40 24%	73 23.2%
30-39 years	55 37.4%	53 31.7%	108 34.4%
40-49 years	27 18.4%	46 27.5%	73 23.2%
50 years and above	27 18.4%	24 14.4%	51 16.2%
Unknown	5 3.4%	4 2.4%	9 2.9%
Sex: Female, Male (Count of Participants)
Female	4 2.7%	3 1.8%	7 2.2%
Male	143 97.3%	164 98.2%	307 97.8%
Race/Ethnicity, Customized (Count of Participants)
Qatar	36 24.5%	25 15%	61 19.4%
Egypt	49 33.3%	41 24.6%	90 28.7%
Other countries	60 40.8%	96 57.5%	156 49.7%
Unknown	2 1.4%	1 0.6%	3 1%

Outcome Measures

1. Primary Outcome

Title	Self-reported 7-day Point Prevalence Abstinence
Description	Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	98	101
Count of Participants [Participants]	26 17.7%	31 18.6%

2. Primary Outcome

Title	Self-reported 30 Day Smoking Abstinence
Description	Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	98	101
Count of Participants [Participants]	22 15%	27 16.2%

3. Primary Outcome

Title	Self-reported Continuous Abstinence at 3 Months
Description	Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	98	101
Count of Participants [Participants]	21 14.3%	25 15%

4. Primary Outcome

Title	Self-reported 7-day Point Prevalence Abstinence
Description	Defined as having smoked no cigarettes for the previous 7 days
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	99	100
Count of Participants [Participants]	21 14.3%	28 16.8%

5. Primary Outcome

Title	Self-reported 30-day Point Prevalence Abstinence
Description	Defined as having smoked no cigarettes in the last 30 days
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	99	100
Count of Participants [Participants]	20 13.6%	27 16.2%

6. Primary Outcome

Title	Self-reported Continuous Abstinence
Description	Defined as having smoked no cigarettes since quit day
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	99	100
Count of Participants [Participants]	20 13.6%	23 13.8%

7. Primary Outcome

Title	Self-reported 7-day Point Prevalence Abstinence
Description	Defined as having smoked no cigarettes for the previous 7 days
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	83	88
Count of Participants [Participants]	14 9.5%	21 12.6%

8. Primary Outcome

Title	Self-reported 30-day Point Prevalence Abstinence
Description	Defined as having smoked no cigarettes in the last 30 days
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	83	88
Count of Participants [Participants]	14 9.5%	21 12.6%

9. Primary Outcome

Title	Self-reported Continuous Abstinence
Description	Defined as having smoked no cigarettes since quit day at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	83	88
Number [participants]	14 9.5%	21 12.6%

10. Primary Outcome

Title	Objective Smoking Abstinence
Description	Smoking abstinence as objectively verified by the CO exhaled test at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	2	6
Count of Participants [Participants]	2 1.4%	6 3.6%

11. Secondary Outcome

Title	Health Related Quality of Life
Description	Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
Time Frame	6 month

Outcome Measure Data

Analysis Population Description

Unfortunately patients didnt return at 6 months to fill the QOL questionnaire this is why we dont have data to report on this measure

Arm/Group Title	Control Arm	Intervention Arm
Arm/Group Description	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).	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.
Measure Participants	0	0
	0	0

Adverse Events

Arm/Group Title	Control Arm		Intervention Arm
Arm/Group Description	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).		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.
All Cause Mortality
	Control Arm		Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/147 (0%)		0/167 (0%)
Serious Adverse Events
	Control Arm		Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/147 (0%)		0/167 (0%)
Other (Not Including Serious) Adverse Events
	Control Arm		Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/147 (0%)		2/167 (1.2%)
Cardiac disorders
Elevated Blood pressure	0/147 (0%)	0	2/167 (1.2%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.