Trial Outcomes & Findings for The Get Quit - Stay Quit Study (NCT NCT01980485)
NCT ID: NCT01980485
Last Updated: 2019-02-26
Results Overview
Exhaled CO \<10 ppm and no tobacco use in the past 7 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
225 participants
Primary outcome timeframe
28 days post quit date
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
Feedback on Lung Age and Exhaled Carbon Monoxide
Lung Age feedback and exhaled carbon monoxide: In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a "normal" FEV-1, the intervention will focus on their exhaled carbon-monoxide.
If their lung age is greater than their chronological age, they will be given their "lung age" in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation.
Those in the Intervention Group will have their exhaled carbon-monoxide (CO) result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided w
|
No Lung Age Feedback
Those allocated to the control group will simply be informed of their scores on the spirometry.
No Lung Age Feedback: Those allocated to the control group will simply be informed of their scores on the spirometry.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
105
|
|
Overall Study
COMPLETED
|
84
|
80
|
|
Overall Study
NOT COMPLETED
|
36
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Get Quit - Stay Quit Study
Baseline characteristics by cohort
| Measure |
Feedback on Lung Age and Exhaled Carbon Monoxide
n=120 Participants
Lung Age feedback and exhaled carbon monoxide: In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a "normal" FEV-1, the intervention will focus on their exhaled carbon-monoxide.
If their lung age is greater than their chronological age, they will be given their "lung age" in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation.
Those in the Intervention Group will have their exhaled carbon-monoxide (CO) result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided w
|
No Lung Age Feedback
n=105 Participants
Those allocated to the control group will simply be informed of their scores on the spirometry.
No Lung Age Feedback: Those allocated to the control group will simply be informed of their scores on the spirometry.
|
Total
n=225 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
|
120 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
225 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
|
47.5 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
49.8 Years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
105 participants
n=7 Participants
|
225 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days post quit dateExhaled CO \<10 ppm and no tobacco use in the past 7 days
Outcome measures
| Measure |
Feedback on Lung Age and Exhaled Carbon Monoxide
n=120 Participants
Lung Age feedback and exhaled carbon monoxide (CO): In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a "normal" FEV-1, the intervention will focus on their exhaled carbon-monoxide. If their lung age is greater than their chronological age, they will be given their "lung age" in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation. Those in the Intervention Group will have their CO result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided with a full explanation.
|
No Lung Age Feedback
n=105 Participants
Those allocated to the control group will simply be informed of their scores on the spirometry.
No Lung Age Feedback: Those allocated to the control group will simply be informed of their scores on the spirometry.
|
|---|---|---|
|
Number of Participants Reporting no Tobacco Use in the Past 7 Days and Have a Validated CO <10ppm
|
61 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Those who were quit at 1 month
Among those who have not smoked in the previous week at visit 7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by exhaled CO \< 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days during the prior 5 months (definition of a relapse in this study)
Outcome measures
| Measure |
Feedback on Lung Age and Exhaled Carbon Monoxide
n=59 Participants
Lung Age feedback and exhaled carbon monoxide (CO): In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a "normal" FEV-1, the intervention will focus on their exhaled carbon-monoxide. If their lung age is greater than their chronological age, they will be given their "lung age" in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation. Those in the Intervention Group will have their CO result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided with a full explanation.
|
No Lung Age Feedback
n=56 Participants
Those allocated to the control group will simply be informed of their scores on the spirometry.
No Lung Age Feedback: Those allocated to the control group will simply be informed of their scores on the spirometry.
|
|---|---|---|
|
Sustained Tobacco Abstinence
|
24 Participants
|
25 Participants
|
Adverse Events
Feedback on Lung Age and Exhaled Carbon Monoxide
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
No Lung Age Feedback
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Feedback on Lung Age and Exhaled Carbon Monoxide
n=120 participants at risk
Lung Age feedback and exhaled carbon monoxide (CO): In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a "normal" FEV-1, the intervention will focus on their exhaled carbon-monoxide. If their lung age is greater than their chronological age, they will be given their "lung age" in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation. Those in the Intervention Group will have their CO result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided with a full explanation.
|
No Lung Age Feedback
n=105 participants at risk
Those allocated to the control group will simply be informed of their scores on the spirometry.
No Lung Age Feedback: Those allocated to the control group will simply be informed of their scores on the spirometry.
|
|---|---|---|
|
General disorders
Flu-like symptoms
|
0.00%
0/120 • 1 year
|
1.9%
2/105 • 1 year
|
|
Cardiac disorders
Cardio related
|
2.5%
3/120 • 1 year
|
0.95%
1/105 • 1 year
|
|
Gastrointestinal disorders
Withdrawal Symptoms
|
15.8%
19/120 • 1 year
|
12.4%
13/105 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Related
|
0.83%
1/120 • 1 year
|
1.9%
2/105 • 1 year
|
|
General disorders
Other
|
1.7%
2/120 • 1 year
|
5.7%
6/105 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place