Trial Outcomes & Findings for Smoking Cessation With the Ottawa Model and SmartCard in Out-patient Respirology Clinic Setting (NCT NCT01495689)

NCT ID: NCT01495689

Last Updated: 2024-01-19

Results Overview

The primary outcome will be measured at 26 weeks: (1) bio-chemically confirmed 7-day point prevalence abstinence; and (2) self reported continuous abstinence since randomization. Participants who will not be available for follow-up will be considered smokers. At the 26 week follow-up, all patients who report being abstinent from smoking will have their smoking status confirmed by measurement of a CO sample. If any CO will be \>10 ppm, the subject will be considered a smoker.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: 26 weeks
• Results posted on: 2024-01-19

Participant Flow

We enrolled and randomized 49 (54.4%) of 90 respirology patients identified as smokers at their routine respirology clinic appointments between November 2011 and December 2012.

Participant milestones

Measure	Usual Care Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing	Ottawa Model With SmartCard On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
Overall Study STARTED	26	23
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Measure	Usual Care Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing	Ottawa Model With SmartCard On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
Overall Study Death	0	1
Overall Study Withdrawal by Subject	3	0
Overall Study Lost to Follow-up	7	6

Baseline Characteristics

Smoking Cessation With the Ottawa Model and SmartCard in Out-patient Respirology Clinic Setting

Baseline characteristics by cohort

Measure	Usual Care n=26 Participants Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing	Ottawa Model With SmartCard n=23 Participants On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50.9 years STANDARD_DEVIATION 10.4 • n=5 Participants	48.3 years STANDARD_DEVIATION 12.6 • n=7 Participants	49.8 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment Canada	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

The primary outcome will be measured at 26 weeks: (1) bio-chemically confirmed 7-day point prevalence abstinence; and (2) self reported continuous abstinence since randomization. Participants who will not be available for follow-up will be considered smokers. At the 26 week follow-up, all patients who report being abstinent from smoking will have their smoking status confirmed by measurement of a CO sample. If any CO will be >10 ppm, the subject will be considered a smoker.

Outcome measures

Measure	Usual Care n=26 Participants Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing	Ottawa Model With SmartCard n=23 Participants On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks.	26 Participants	23 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: \[Not Specified\]

Self-reported smoking status was the primary indicator of effectiveness and was obtained at 26-52 weeks. Participants were asked to respond "yes" or "no" to the question "Do you still smoke?"

Outcome measures

Measure	Usual Care n=26 Participants Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing	Ottawa Model With SmartCard n=23 Participants On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
Self-reported Smoking Status Self-reported non-smoker status	2 Participants	4 Participants
Self-reported Smoking Status did not report report non-smoker status	24 Participants	19 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: \[not specified\]

Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial

Outcome measures

Measure	Usual Care n=26 Participants Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing	Ottawa Model With SmartCard n=23 Participants On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
Rate of Recruitment and Retention Complete self-reported smoking status data	16 Participants	16 Participants
Rate of Recruitment and Retention Did not complete self-reported smoking status data	10 Participants	7 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ottawa Model With SmartCard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Smita Pakhale

Ottawa Hospital Research Institute

Phone: 613-737-8899

Email: spakhale@ohri.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place