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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Smoking Cessation
Interventions Behavioral: Pharmacist delivered smoking cessation program
Other: Control arm (i.e: regular care)
Enrollment 314
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
Pre-assignment Details  
Arm/Group Title Control Arm Intervention Arm
Hide 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: 6 Month Outcome Measure
Started 147 167
Completed 99 100
Not Completed 48 67
Period Title: 12 Month Outcome Measure
Started 147 167
Completed 83 88
Not Completed 64 79
Arm/Group Title Control Arm Intervention Arm Total
Hide 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 Number of Baseline Participants 147 167 314
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 167 participants 314 participants
18-29 years
33
  22.4%
40
  24.0%
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 167 participants 314 participants
Female
4
   2.7%
3
   1.8%
7
   2.2%
Male
143
  97.3%
164
  98.2%
307
  97.8%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 167 participants 314 participants
Qatar
36
  24.5%
25
  15.0%
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
   1.0%
[1]
Measure Description: Nationality
1.Primary Outcome
Title Self-reported 7-day Point Prevalence Abstinence
Hide Description Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide 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.
Overall Number of Participants Analyzed 98 101
Measure Type: Count of Participants
Unit of Measure: Participants
26
  26.5%
31
  30.7%
2.Primary Outcome
Title Self-reported 30 Day Smoking Abstinence
Hide Description Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide 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.
Overall Number of Participants Analyzed 98 101
Measure Type: Count of Participants
Unit of Measure: Participants
22
  22.4%
27
  26.7%
3.Primary Outcome
Title Self-reported Continuous Abstinence at 3 Months
Hide Description Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide 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.
Overall Number of Participants Analyzed 98 101
Measure Type: Count of Participants
Unit of Measure: Participants
21
  21.4%
25
  24.8%
4.Primary Outcome
Title Self-reported 7-day Point Prevalence Abstinence
Hide Description Defined as having smoked no cigarettes for the previous 7 days
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide 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.
Overall Number of Participants Analyzed 99 100
Measure Type: Count of Participants
Unit of Measure: Participants
21
  21.2%
28
  28.0%
5.Primary Outcome
Title Self-reported 30-day Point Prevalence Abstinence
Hide Description Defined as having smoked no cigarettes in the last 30 days
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide 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.
Overall Number of Participants Analyzed 99 100
Measure Type: Count of Participants
Unit of Measure: Participants
20
  20.2%
27
  27.0%
6.Primary Outcome
Title Self-reported Continuous Abstinence
Hide Description Defined as having smoked no cigarettes since quit day
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide 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.
Overall Number of Participants Analyzed 99 100
Measure Type: Count of Participants
Unit of Measure: Participants
20
  20.2%
23
  23.0%
7.Primary Outcome
Title Self-reported 7-day Point Prevalence Abstinence
Hide Description Defined as having smoked no cigarettes for the previous 7 days
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide 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.
Overall Number of Participants Analyzed 83 88
Measure Type: Count of Participants
Unit of Measure: Participants
14
  16.9%
21
  23.9%
8.Primary Outcome
Title Self-reported 30-day Point Prevalence Abstinence
Hide Description Defined as having smoked no cigarettes in the last 30 days
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide 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.
Overall Number of Participants Analyzed 83 88
Measure Type: Count of Participants
Unit of Measure: Participants
14
  16.9%
21
  23.9%
9.Primary Outcome
Title Self-reported Continuous Abstinence
Hide Description Defined as having smoked no cigarettes since quit day at 12 months
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide 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.
Overall Number of Participants Analyzed 83 88
Measure Type: Number
Unit of Measure: participants
14 21
10.Primary Outcome
Title Objective Smoking Abstinence
Hide Description Smoking abstinence as objectively verified by the CO exhaled test at 12 months
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide 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.
Overall Number of Participants Analyzed 2 6
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
6
 100.0%
11.Secondary Outcome
Title Health Related Quality of Life
Hide Description Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
Time Frame 6 month
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Arm Intervention Arm
Hide 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 (%) Affected / at Risk (%)
Total   0/147 (0.00%)      0/167 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Control Arm Intervention Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/147 (0.00%)      0/167 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Arm Intervention Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/147 (0.00%)      2/167 (1.20%)    
Cardiac disorders     
Elevated Blood pressure * [1]  0/147 (0.00%)  0 2/167 (1.20%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Elevated Blood pressure due to nicotine replacement therapy
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.
Results Point of Contact
Name/Title: Dr. Maguy El Hajj
Organization: Qatar University College of Pharmacy
Phone: 0097444035577
Responsible Party: Dr. Maguy El Hajj, Qatar University
ClinicalTrials.gov Identifier: NCT02123329     History of Changes
Other Study ID Numbers: NPRP 4 - 716 - 3 - 203
First Submitted: April 20, 2014
First Posted: April 25, 2014
Results First Submitted: July 24, 2016
Results First Posted: January 2, 2018
Last Update Posted: January 2, 2018