Smoking Cessation Clinical Trial
Official title:
Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector
The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.
Status | Recruiting |
Enrollment | 608 |
Est. completion date | February 28, 2027 |
Est. primary completion date | February 28, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Company leaders: - = 18 years - Involved in decision making - Willing to participate in the implementation development and evaluation Safety Managers: - = 18 years - Be a safety manager - No plans to leave the company within the next year - Bilingual - Willing to receive training in smoking cessation treatment - Willing to deliver the smoking cessation treatment to workers Construction Workers: - Be a construction worker - = 18 years - Have smoked on average 5 or more cigarettes daily for the past year - Willing to make a serious quit attempt in the next 30 days - Planning to stay in the company for the next 6 months - Own a telephone and plan to keep it active for the next 12 months Exclusion Criteria: Safety Managers: - Current cigarette smoker |
Country | Name | City | State |
---|---|---|---|
United States | Don Soffer Clinical Research Center | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | Florida Department of Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Program Effectiveness Measure in Percentage | Will be collected as the difference in percentage of participants who quit smoking at the 12-month follow-up assessment between the three treatment groups. | Up to 4 years | |
Primary | Program Cost-Effectiveness Measured by Number of U.S Dollars | Will be measured as the difference in the number of U.S. dollars between the three programs. | Up to 4 years | |
Primary | Program Cost-Effectiveness Measured by Quality Adjusted Life Years | Will be measured by quality-adjusted life years defined as the difference in the number of years lived in perfect health between the three programs. | Up to 4 years | |
Secondary | Program's Implementation- Acceptability Measured by Likert Scale | Using the Acceptability of Intervention Measure, acceptability will be scored on a 5-point Likert scale, with higher scores indicating greater acceptability. | Up to 4 years | |
Secondary | Program's Implementation- Feasibility Measured by Likert Scale | Using the Feasibility of Intervention Measure, feasibility will be scored on a 5-point Likert scale, with higher scores indicating greater feasibility. | Up to 4 years | |
Secondary | Program's Implementation- Sustainability Measured by Likert Scale | Using the Intervention Sustainability Assessment Tool, sustainability will be scored on a 7-point Likert scale, with higher scores indicating greater sustainability. | Up to 4 years |
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