Trial Outcomes & Findings for Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar (NCT NCT02123329)
NCT ID: NCT02123329
Last Updated: 2018-01-02
Results Overview
Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
314 participants
Primary outcome timeframe
3 months
Results posted on
2018-01-02
Participant Flow
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
Participant milestones
| Measure |
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).
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).
|
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.
|
|---|---|---|
|
3 Month Outcome Measure
STARTED
|
147
|
167
|
|
3 Month Outcome Measure
COMPLETED
|
98
|
101
|
|
3 Month Outcome Measure
NOT COMPLETED
|
49
|
66
|
|
6 Month Outcome Measure
STARTED
|
147
|
167
|
|
6 Month Outcome Measure
COMPLETED
|
99
|
100
|
|
6 Month Outcome Measure
NOT COMPLETED
|
48
|
67
|
|
12 Month Outcome Measure
STARTED
|
147
|
167
|
|
12 Month Outcome Measure
COMPLETED
|
83
|
88
|
|
12 Month Outcome Measure
NOT COMPLETED
|
64
|
79
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
Baseline characteristics by cohort
| Measure |
Control Arm
n=147 Participants
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).
|
Intervention Arm
n=167 Participants
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
n=314 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-29 years
|
33 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Age, Customized
30-39 years
|
55 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Age, Customized
40-49 years
|
27 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Age, Customized
50 years and above
|
27 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Age, Customized
Unknown
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=93 Participants
|
164 Participants
n=4 Participants
|
307 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Qatar
|
36 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Egypt
|
49 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other countries
|
60 Participants
n=93 Participants
|
96 Participants
n=4 Participants
|
156 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsSelf-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
Outcome measures
| Measure |
Control Arm
n=98 Participants
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).
|
Intervention Arm
n=101 Participants
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.
|
|---|---|---|
|
Self-reported 7-day Point Prevalence Abstinence
|
26 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: 3 monthsSelf-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
Outcome measures
| Measure |
Control Arm
n=98 Participants
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).
|
Intervention Arm
n=101 Participants
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.
|
|---|---|---|
|
Self-reported 30 Day Smoking Abstinence
|
22 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsSelf-reported continuous abstinence defined as having smoked no cigarettes since quit day
Outcome measures
| Measure |
Control Arm
n=98 Participants
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).
|
Intervention Arm
n=101 Participants
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.
|
|---|---|---|
|
Self-reported Continuous Abstinence at 3 Months
|
21 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: 6 monthsDefined as having smoked no cigarettes for the previous 7 days
Outcome measures
| Measure |
Control Arm
n=99 Participants
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).
|
Intervention Arm
n=100 Participants
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.
|
|---|---|---|
|
Self-reported 7-day Point Prevalence Abstinence
|
21 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: 6 monthsDefined as having smoked no cigarettes in the last 30 days
Outcome measures
| Measure |
Control Arm
n=99 Participants
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).
|
Intervention Arm
n=100 Participants
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.
|
|---|---|---|
|
Self-reported 30-day Point Prevalence Abstinence
|
20 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsDefined as having smoked no cigarettes since quit day
Outcome measures
| Measure |
Control Arm
n=99 Participants
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).
|
Intervention Arm
n=100 Participants
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.
|
|---|---|---|
|
Self-reported Continuous Abstinence
|
20 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 12 monthsDefined as having smoked no cigarettes for the previous 7 days
Outcome measures
| Measure |
Control Arm
n=83 Participants
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).
|
Intervention Arm
n=88 Participants
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.
|
|---|---|---|
|
Self-reported 7-day Point Prevalence Abstinence
|
14 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsDefined as having smoked no cigarettes in the last 30 days
Outcome measures
| Measure |
Control Arm
n=83 Participants
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).
|
Intervention Arm
n=88 Participants
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.
|
|---|---|---|
|
Self-reported 30-day Point Prevalence Abstinence
|
14 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsDefined as having smoked no cigarettes since quit day at 12 months
Outcome measures
| Measure |
Control Arm
n=83 Participants
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).
|
Intervention Arm
n=88 Participants
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.
|
|---|---|---|
|
Self-reported Continuous Abstinence
|
14 participants
|
21 participants
|
PRIMARY outcome
Timeframe: 12 monthsSmoking abstinence as objectively verified by the CO exhaled test at 12 months
Outcome measures
| Measure |
Control Arm
n=2 Participants
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).
|
Intervention Arm
n=6 Participants
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.
|
|---|---|---|
|
Objective Smoking Abstinence
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthPopulation: Unfortunately patients didnt return at 6 months to fill the QOL questionnaire this is why we dont have data to report on this measure
Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
Outcome measures
| Measure |
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).
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).
|
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.
|
|---|---|---|
|
Health Related Quality of Life
|
0
|
0
|
Adverse Events
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Arm
n=147 participants at risk
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).
|
Intervention Arm
n=167 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Elevated Blood pressure
|
0.00%
0/147
|
1.2%
2/167 • Number of events 2
|
Additional Information
Dr. Maguy El Hajj
Qatar University College of Pharmacy
Phone: 0097444035577
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place