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Smoking Cessation With the Ottawa Model and SmartCard in Out-patient Respirology Clinic Setting (Quit&Win)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01495689
Recruitment Status : Completed
First Posted : December 20, 2011
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Ottawa Heart Institute Research Corporation
Information provided by (Responsible Party):
Smita Pakhale, Ottawa Hospital Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Smoking Cessation
Interventions Behavioral: Ottawa Model with SmartCard
Behavioral: Usual care
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Care Ottawa Model With SmartCard
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 26 23
Completed 16 16
Not Completed 10 7
Arm/Group Title Usual Care Ottawa Model With SmartCard Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 26 23 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
23
 100.0%
49
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 23 participants 49 participants
50.9  (10.4) 48.3  (12.6) 49.8  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 49 participants
Female
13
  50.0%
12
  52.2%
25
  51.0%
Male
13
  50.0%
11
  47.8%
24
  49.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 26 participants 23 participants 49 participants
26
 100.0%
23
 100.0%
49
 100.0%
1.Primary Outcome
Title Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks.
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Ottawa Model With SmartCard
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 26 23
Measure Type: Count of Participants
Unit of Measure: Participants
26
 100.0%
23
 100.0%
2.Secondary Outcome
Title Cost-effectiveness Analysis
Hide Description We will measure direct and indirect costs of the intervention and perform cost-effectiveness analysis of the intervention provided in the out-patient setting with a dedicated nurse available to deliver the intervention.
Time Frame 6 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Rate of Recruitment and Retention
Hide Description Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Ottawa Model With SmartCard
Hide Arm/Group Description

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

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

All-Cause Mortality
Usual Care Ottawa Model With SmartCard
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Ottawa Model With SmartCard
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Ottawa Model With SmartCard
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/23 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Smita Pakhale
Organization: Ottawa Hospital Research Institute
Phone: 613-737-8899 ext 79428
EMail: spakhale@ohri.ca
Layout table for additonal information
Responsible Party: Smita Pakhale, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01495689     History of Changes
Other Study ID Numbers: OHRI
First Submitted: December 16, 2011
First Posted: December 20, 2011
Results First Submitted: March 23, 2017
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017