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
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Internet-based Behavioral: Standard Clinic-Based||Not Applicable|
Project Background: Veterans returning from Iraq and Afghanistan are smoking at high rates and are at elevated risk for the development of smoking related illness. Intensive speciality clinic-based tobacco cessation programs have high efficacy, are more cost effective than less intensive approaches, and are employed by most VA medical centers. These programs, however, are infrequently attended by veterans, limiting the impact on prevalence, disease burden, and economic costs of smoking. An internet-based smoking cessation intervention could be an effective, low-cost method to implement evidence based smoking cessation principles. The internet could significantly increase the impact of smoking cessation efforts over current approaches by avoiding barriers that limit utilization of existing clinic-based services.
Project Objectives: The goal of the study is to evaluate the impact of an internet-based intervention in comparison to standard VA speciality clinic-based care in promoting smoking cessation in returning veterans. Accordingly, the specific aims and hypotheses are:
AIM 1: To evaluate the impact of an internet-based smoking cessation intervention on rates of abstinence from cigarettes (self-reported 7-day point prevalent abstinence) at 3 months and 12-month post-treatment follow-ups.
Hypothesis 1: Abstinence rates will be significantly higher among veterans randomized to the web-based intervention than those randomized to VA specialty cessation care.
AIM 2: To evaluate the impact of an internet-based smoking cessation intervention on reach of smoking cessation treatment.
Hypothesis 2.1: Internet-based treatment will result in increased reach as measured by the proportion of patients who access care. Hypothesis 2.2: Internet-based treatment will result in engagement in treatment as measured by the proportion of patients that make at least one quit attempt.
AIM 3: To evaluate the relative cost-effectiveness of the standard specialty care intervention to the web-based intervention.
Project Methods: Proposed is a trial in which 410 OEF/OIF veteran smokers will be randomized to receive either an internet-based smoking cessation intervention and nicotine replacement therapy or referral to VA specialty smoking cessation care, which includes behavioral therapy, group counseling, telephone counseling, self-help materials, and choice of smoking cessation aid (pharmacotherapy).
Participating patients will be surveyed at 3 months post-intervention and at 12 months. The primary outcome of the trial is a 7-day point prevalence abstinence at the 3-month post intervention follow-up, as measured by self-report and verified by cotinine assay.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||413 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Internet-Based Smoking Cessation for OEF/OIF Veterans|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Arm 1
Internet-based smoking cessation
Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
Other Name: Intervention
Clinic-based smoking cessation
Behavioral: Standard Clinic-Based
Veterans randomized to the control condition will have a consult placed to the Durham VA Medical Center (DVAMC) specialty Smoking Cessation Clinic placed on their behalf.
Other Name: Control
- The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence) [ Time Frame: 3 months post treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001546
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Patrick S. Calhoun, PhD||Durham VA Medical Center, Durham, NC|