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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01001546
First received: October 23, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

The overarching aim of the study is to evaluate in a randomized trial the impact of an internet intervention compared to a standard clinic-based control group to promote smoking cessation among Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) veterans.


Condition Intervention
Smoking Cessation
Behavioral: Internet-based
Behavioral: Standard Clinic-Based

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-Based Smoking Cessation for OEF/OIF Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 410
Study Start Date: May 2010
Estimated Study Completion Date: July 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Internet-based smoking cessation
Behavioral: Internet-based
Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.
Other Name: Intervention
Arm 2
Clinic-based smoking cessation
Behavioral: 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.
Other Name: Control

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in DVAMC for ongoing care
  • Served during OEF/OIF
  • Current smokers willing to make a quit attempt in the next 30 days

Exclusion Criteria:

  • Active diagnosis of psychosis in the medical record
  • Diagnosis of severe dementia in the medical record
  • Does not have access to a telephone
  • Severely impaired hearing or speech (veterans must be able to respond to phone calls)
  • Refusal to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001546

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Patrick S. Calhoun, PhD Department of Veterans Affairs
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01001546     History of Changes
Other Study ID Numbers: IIR 08-032
Study First Received: October 23, 2009
Last Updated: July 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Veterans
Smoking cessation
Operation Enduring Freedom
Operation Iraqi Freedom

ClinicalTrials.gov processed this record on August 20, 2014