Trial Outcomes & Findings for Internet-Based Smoking Cessation for Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans (NCT NCT01001546)
NCT ID: NCT01001546
Last Updated: 2015-04-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
413 participants
Primary outcome timeframe
3 months post treatment
Results posted on
2015-04-27
Participant Flow
Participant milestones
| Measure |
Intervention
Internet-based smoking cessation
Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
|
Control
Clinic-based smoking cessation
Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf.
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
207
|
|
Overall Study
COMPLETED
|
206
|
207
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Internet-Based Smoking Cessation for Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans
Baseline characteristics by cohort
| Measure |
Intervention
n=206 Participants
Internet-based smoking cessation
Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
|
Control
n=207 Participants
Clinic-based smoking cessation
Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf.
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
175 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
194 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
76 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
206 participants
n=5 Participants
|
207 participants
n=7 Participants
|
413 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post treatmentOutcome measures
| Measure |
Intervention
n=206 Participants
Internet-based smoking cessation
Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
|
Control
n=207 Participants
Clinic-based smoking cessation
Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf.
|
|---|---|---|
|
The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence)
|
34.4 percentage of participants
|
24.7 percentage of participants
|
Adverse Events
Intervention
Serious events: 9 serious events
Other events: 9 other events
Deaths: 0 deaths
Control
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=206 participants at risk
Internet-based smoking cessation
Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
|
Control
n=207 participants at risk
Clinic-based smoking cessation
Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization - mental health
|
0.49%
1/206 • Number of events 1 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
1.4%
3/207 • Number of events 3 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization - respiratory
|
1.5%
3/206 • Number of events 3 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
0.00%
0/207 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
|
Cardiac disorders
Hospitalization - cardiac
|
0.97%
2/206 • Number of events 2 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
0.00%
0/207 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
|
Surgical and medical procedures
Hospitalization - knee surgery
|
0.97%
2/206 • Number of events 2 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
0.48%
1/207 • Number of events 1 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
|
General disorders
Death
|
0.49%
1/206 • Number of events 1 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
1.4%
3/207 • Number of events 3 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
Other adverse events
| Measure |
Intervention
n=206 participants at risk
Internet-based smoking cessation
Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
|
Control
n=207 participants at risk
Clinic-based smoking cessation
Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf.
|
|---|---|---|
|
Gastrointestinal disorders
Adverse reaction to Nicotine Replacement Medication (NRT)
|
1.5%
3/206 • Number of events 3 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
0.97%
2/207 • Number of events 2 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
|
Social circumstances
Motor Vehicle Accident
|
0.00%
0/206 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
0.97%
2/207 • Number of events 2 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
|
Skin and subcutaneous tissue disorders
Adverse reaction to Nicotine Replacement Medication (NRT)
|
0.49%
1/206 • Number of events 1 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
0.00%
0/207 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Adverse reaction to Nicotine Replacement Medication (NRT)
|
1.9%
4/206 • Number of events 4 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
0.00%
0/207 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy/Childbirth
|
0.00%
0/206 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
0.48%
1/207 • Number of events 1 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
|
Surgical and medical procedures
Minor Procedure
|
0.49%
1/206 • Number of events 1 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
0.97%
2/207 • Number of events 2 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/206 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
0.48%
1/207 • Number of events 1 • The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place