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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Internet-based smoking cessation |
|
| Arm 2 | Other | Clinic-based smoking cessation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based | Behavioral | Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence) | 3 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick S. Calhoun, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22038468 | Result | Gierisch JM, Bastian LA, Calhoun PS, McDuffie JR, Williams JW Jr. Smoking cessation interventions for patients with depression: a systematic review and meta-analysis. J Gen Intern Med. 2012 Mar;27(3):351-60. doi: 10.1007/s11606-011-1915-2. Epub 2011 Oct 26. | |
| 21769051 | Result | Zaborowski DE, Dedert EA, Straits-Troster K, Lee S, Wilson SM, Calhoun PS, Moore SD, Acheson S, Hamlett-Berry KW, Beckham JC. Public health clinical demonstration project for smoking cessation in american veterans who served since september 11, 2001. J Addict Med. 2011 Mar;5(1):79-83. doi: 10.1097/ADM.0b013e3181df97d5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Internet-based smoking cessation Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Internet-based smoking cessation Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence) | Posted | Number | percentage of participants | 3 months post treatment |
|
The reporting period for adverse events was the duration of study participation for each participant:12 months from the date of enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Internet-based smoking cessation Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization - mental health | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse reaction to Nicotine Replacement Medication (NRT) | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick S. Calhoun | Durham VA Medical Center - HSRD | 919-286-0411 | 7970 | patrick.calhoun2@va.gov |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Standard Clinic-Based | Behavioral | 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. |
|
|
| 21523829 | Result | Calhoun PS, Levin HF, Dedert EA, Johnson Y; VA Mid-Atlantic Mental Illness Research, Education, Clinical Center Registry Workgroup; Beckham JC. The relationship between posttraumatic stress disorder and smoking outcome expectancies among U.S. military veterans who served since September 11, 2001. J Trauma Stress. 2011 Jun;24(3):303-8. doi: 10.1002/jts.20634. Epub 2011 Apr 26. |
| Result | 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). |
| 22338598 | Result | Gierisch JM, Straits-Troster K, Calhoun PS, Beckham JC, Acheson S, Hamlett-Berry K. Tobacco use among Iraq- and Afghanistan-era veterans: a qualitative study of barriers, facilitators, and treatment preferences. Prev Chronic Dis. 2012;9:E58. doi: 10.5888/pcd9.110131. Epub 2012 Feb 16. |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 9 |
| 206 |
| 9 |
| 206 |
| EG001 | 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. | 7 | 207 | 8 | 207 |
| Hospitalization - respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalization - cardiac | Cardiac disorders | Non-systematic Assessment |
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| Hospitalization - knee surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment |
|
| Motor Vehicle Accident | Social circumstances | Non-systematic Assessment | Not seriously injured |
|
| Adverse reaction to Nicotine Replacement Medication (NRT) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Adverse reaction to Nicotine Replacement Medication (NRT) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pregnancy/Childbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Minor Procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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