Trial Outcomes & Findings for Connect to Quit for Smoking (NCT NCT01299896)
NCT ID: NCT01299896
Last Updated: 2016-03-22
Results Overview
We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine \<10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
633 participants
Primary outcome timeframe
Two (2) year period
Results posted on
2016-03-22
Participant Flow
Participant milestones
| Measure |
Usual Care
Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (VAPHS), including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.
Usual Care: Standard therapy to help participants with smoking cessation.
|
Coordinated Care
A CTQ Coordinator will coordinate the delivery of smoking related care.
Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.
|
|---|---|---|
|
Overall Study
STARTED
|
319
|
314
|
|
Overall Study
COMPLETED
|
318
|
296
|
|
Overall Study
NOT COMPLETED
|
1
|
18
|
Reasons for withdrawal
| Measure |
Usual Care
Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (VAPHS), including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.
Usual Care: Standard therapy to help participants with smoking cessation.
|
Coordinated Care
A CTQ Coordinator will coordinate the delivery of smoking related care.
Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
11
|
Baseline Characteristics
Connect to Quit for Smoking
Baseline characteristics by cohort
| Measure |
Usual Care
n=319 Participants
Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.
Usual Care: Standard therapy to help participants with smoking cessation.
|
Coordinated Care
n=314 Participants
A CTQ Coordinator will coordinate the delivery of smoking related care.
Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.
|
Total
n=633 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
55.7 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
55.2 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
291 Participants
n=99 Participants
|
276 Participants
n=107 Participants
|
567 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
319 participants
n=99 Participants
|
314 participants
n=107 Participants
|
633 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Two (2) year periodWe will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine \<10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.
Outcome measures
| Measure |
Usual Care
n=319 Participants
Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.
Usual Care: Standard therapy to help participants with smoking cessation.
|
Coordinated Care
n=314 Participants
A CTQ Coordinator will coordinate the delivery of smoking related care.
Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.
|
|---|---|---|
|
Effectiveness of CTQ vs UC
|
7.5 percentage of participants per arm
|
6.1 percentage of participants per arm
|
Adverse Events
Usual Care
Serious events: 181 serious events
Other events: 0 other events
Deaths: 0 deaths
Coordinated Care
Serious events: 175 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=319 participants at risk
Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.
Usual Care: Standard therapy to help participants with smoking cessation.
|
Coordinated Care
n=314 participants at risk
A CTQ Coordinator will coordinate the delivery of smoking related care.
Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.
|
|---|---|---|
|
General disorders
Hospitalization
|
49.2%
157/319 • Events were collected starting at day 0 and continuing at six month intervals for a minimum of two years maximum 4 years pending date of enrollment.
Hospitalization is the most common serious adverse event for our study population because hospitalization is common among smokers. Serious adverse events were obtained during follow up assessments and/or through chart extraction.
|
51.6%
162/314 • Events were collected starting at day 0 and continuing at six month intervals for a minimum of two years maximum 4 years pending date of enrollment.
Hospitalization is the most common serious adverse event for our study population because hospitalization is common among smokers. Serious adverse events were obtained during follow up assessments and/or through chart extraction.
|
|
General disorders
Death
|
7.5%
24/319 • Events were collected starting at day 0 and continuing at six month intervals for a minimum of two years maximum 4 years pending date of enrollment.
Hospitalization is the most common serious adverse event for our study population because hospitalization is common among smokers. Serious adverse events were obtained during follow up assessments and/or through chart extraction.
|
4.1%
13/314 • Number of events 295 • Events were collected starting at day 0 and continuing at six month intervals for a minimum of two years maximum 4 years pending date of enrollment.
Hospitalization is the most common serious adverse event for our study population because hospitalization is common among smokers. Serious adverse events were obtained during follow up assessments and/or through chart extraction.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place