Tobacco Tactics Website for Operating Engineers (BCBSM-OE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Sonia Duffy, University of Michigan
ClinicalTrials.gov Identifier:
NCT01124110
First received: May 13, 2010
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

This is a clustered randomized control trial to test the Tobacco Tactics intervention among Operating Engineers (heavy equipment workers). The intervention group will be directed to the Tobacco Tactics website, and the control group will be directed to the state supported 1-800 quit-now telephone hotline during routine annual safety training that all Operating Engineers are required to attend. The web-based quitting intervention includes provision of over-the-counter nicotine replacement therapy and will be followed by nurse email and/or telephone counseling. It is expected that Operating Engineers who are randomized to the Tobacco Tactics website intervention will have at least equal or greater decreases in smoking at 30-day and 6-month follow-up compared to those randomized to the 1-800-QUIT-NOW quit line. In addition, the investigators expect to find that Operating Engineers randomized to the Tobacco Tactics website intervention will: a) be able to accomplish tasks; b) be able to accomplish goals with skill and speed; c) be able to operate the system; d) be satisfied with the website; e) access the site repeatedly; and f) spend time on the site during the intervention period.


Condition Intervention Phase
Smoking
Tobacco Use Cessation
Behavioral: Tobacco Tactics Web-Based Intervention
Other: 1-800-QUIT-NOW Telephone Hotline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tobacco Tactics Website for Operating Engineers

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Quit Rate [ Time Frame: 30-day Follow-Up ] [ Designated as safety issue: No ]
    The investigators will measure 7-day point prevalence abstinence by asking the well validated question, "Have you used any tobacco products (even one puff) in the past 7 days?" The investigators will also assess harm reduction (ability to quit at all, number of quit attempts, and number of cigarettes smoked per day).

  • Quit Rate [ Time Frame: 6-Month Follow-Up ] [ Designated as safety issue: No ]
    The investigators will measure 7-day point prevalence abstinence by asking the well validated question, "Have you used any tobacco products (even one puff) in the past 7 days?" Smoking status will be confirmed by biochemical verification in the form of urinary cotinine test strips. The investigators will also assess harm reduction (ability to quit at all, number of quit attempts, and number of cigarettes smoked per day).


Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: August 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1-800-QUIT-NOW Telephone Hotline
The control group receives efficacious smoking cessation treatment via the 1-800-QUIT-NOW telephone hotline. The 1-800-QUIT-NOW hotline is a national program. The first time smokers call the hotline, they receive a personal coach who assists them in setting a quit date and making an individualized quit plan. The personal coach also provides on-going support with up to five telephone coaching sessions around the caller's quit date.
Other: 1-800-QUIT-NOW Telephone Hotline
The control group receives efficacious smoking cessation treatment via the 1-800-QUIT-NOW telephone hotline. The 1-800-QUIT-NOW hotline is a national program. The first time smokers call the hotline, they receive a personal coach who assists them in setting a quit date and making an individualized quit plan. The personal coach also provides on-going support with up to five telephone coaching sessions around the caller's quit date.
Experimental: Tobacco Tactics Intervention
This intervention contains a website, medications, and nurse counseling.
Behavioral: Tobacco Tactics Web-Based Intervention
The Tobacco Tactics Web-Based Intervention contains website, medications, and nurse counseling.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • attending a training session provided by the Operating Engineers Local 324 Education Center
  • greater than 18 years of age
  • smoked cigarettes in the past month
  • interested in participating in a program to quit smoking
  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: NCT01124110

Locations
United States, Michigan
University of Michigan, School of Nursing
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Blue Cross Blue Shield of Michigan Foundation
Investigators
Principal Investigator: Sonia A Duffy, PhD, RN University of Michigan
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sonia Duffy, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01124110     History of Changes
Other Study ID Numbers: N011646 - 1465.RFP
Study First Received: May 13, 2010
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Operating Engineers
Smoking Cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014