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Internet-Based Smoking Cessation for Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans

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ClinicalTrials.gov Identifier: NCT01001546
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : March 9, 2015
Last Update Posted : April 27, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Smoking Cessation
Interventions Behavioral: Internet-based
Behavioral: Standard Clinic-Based
Enrollment 413
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description

Internet-based smoking cessation

Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.

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.

Period Title: Overall Study
Started 206 207
Completed 206 207
Not Completed 0 0
Arm/Group Title Intervention Control Total
Hide Arm/Group Description

Internet-based smoking cessation

Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.

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 of all reporting groups
Overall Number of Baseline Participants 206 207 413
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 206 participants 207 participants 413 participants
43.4  (13.7) 42.9  (14.4) 43.1  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 207 participants 413 participants
Female
31
  15.0%
33
  15.9%
64
  15.5%
Male
175
  85.0%
174
  84.1%
349
  84.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 207 participants 413 participants
Hispanic or Latino
10
   4.9%
7
   3.4%
17
   4.1%
Not Hispanic or Latino
194
  94.2%
199
  96.1%
393
  95.2%
Unknown or Not Reported
2
   1.0%
1
   0.5%
3
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 207 participants 413 participants
American Indian or Alaska Native
3
   1.5%
7
   3.4%
10
   2.4%
Asian
1
   0.5%
0
   0.0%
1
   0.2%
Native Hawaiian or Other Pacific Islander
2
   1.0%
1
   0.5%
3
   0.7%
Black or African American
76
  36.9%
86
  41.5%
162
  39.2%
White
105
  51.0%
104
  50.2%
209
  50.6%
More than one race
19
   9.2%
9
   4.3%
28
   6.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 206 participants 207 participants 413 participants
206 207 413
1.Primary Outcome
Title The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence)
Hide Description [Not Specified]
Time Frame 3 months post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Internet-based smoking cessation

Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.

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 Number of Participants Analyzed 206 207
Measure Type: Number
Unit of Measure: percentage of participants
34.4 24.7
Time Frame The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide Arm/Group Description

Internet-based smoking cessation

Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.

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.

All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/206 (4.37%)      7/207 (3.38%)    
Cardiac disorders     
Hospitalization - cardiac *  2/206 (0.97%)  2 0/207 (0.00%)  0
General disorders     
Death *  1/206 (0.49%)  1 3/207 (1.45%)  3
Psychiatric disorders     
Hospitalization - mental health *  1/206 (0.49%)  1 3/207 (1.45%)  3
Respiratory, thoracic and mediastinal disorders     
Hospitalization - respiratory *  3/206 (1.46%)  3 0/207 (0.00%)  0
Surgical and medical procedures     
Hospitalization - knee surgery *  2/206 (0.97%)  2 1/207 (0.48%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/206 (4.37%)      8/207 (3.86%)    
Gastrointestinal disorders     
Adverse reaction to Nicotine Replacement Medication (NRT) *  3/206 (1.46%)  3 2/207 (0.97%)  2
Musculoskeletal and connective tissue disorders     
Pain *  0/206 (0.00%)  0 1/207 (0.48%)  1
Pregnancy, puerperium and perinatal conditions     
Pregnancy/Childbirth *  0/206 (0.00%)  0 1/207 (0.48%)  1
Respiratory, thoracic and mediastinal disorders     
Adverse reaction to Nicotine Replacement Medication (NRT) *  4/206 (1.94%)  4 0/207 (0.00%)  0
Skin and subcutaneous tissue disorders     
Adverse reaction to Nicotine Replacement Medication (NRT) *  1/206 (0.49%)  1 0/207 (0.00%)  0
Social circumstances     
Motor Vehicle Accident * [1]  0/206 (0.00%)  0 2/207 (0.97%)  2
Surgical and medical procedures     
Minor Procedure *  1/206 (0.49%)  1 2/207 (0.97%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Not seriously injured
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Patrick S. Calhoun
Organization: Durham VA Medical Center - HSRD
Phone: 919-286-0411 ext 7970
Publications of Results:
Straits-Troster K, Acheson S, Beckham JC, Calhoun PS, Gierisch JM, Hamlett-Berry K. Tobacco use and cessation among returning combat veterans: A mixed methods study. [Abstract]. Behavioral medicine update : a publication of the Society of Behavioral Medicine. 2010 Apr 10; 39(S1).
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT01001546     History of Changes
Other Study ID Numbers: IIR 08-032
First Submitted: October 23, 2009
First Posted: October 26, 2009
Results First Submitted: January 13, 2015
Results First Posted: March 9, 2015
Last Update Posted: April 27, 2015