- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01826331
Incentives for Participation Versus Outcomes
Incentives for Participation Versus Outcomes for Population Cessation of Smoking
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This population-based randomized clinical trial is designed to compare long-term abstinence rates in three groups of smokers: 1. Those incentivized for participation in an evidence-based treatment designed for smokers at each stage of change; 2. Those incentivized for biologically validated prolonged abstinence at 6 and 12 months who could also choose to participate in the TTM (Transtheoretical Model)-tailored intervention; and 3. An assessment only control condition.
The Specific Aims are:
- To assess whether the treatment group incentivized for participation outperforms the control group at 12, 24 and 36 months as hypothesized;
- To assess whether the treatment group incentivized for prolonged abstinence at 6 and 12 months outperforms the control group at each follow-up as hypothesized;
- To assess whether the treatment group incentivized for participation outperforms the treatment group incentivized for outcomes at 36 months as hypothesized.
- To compare the cost-effectiveness of each treatment in a population of mostly unmotivated smokers;
The Secondary Aims are:
- To assess the long-term treatment trajectories of each treatment compared to controls with hypothesized increasing trajectory in the participation contingent incentives and decreasing trajectory in the outcome contingent incentives.
- To identify mediators of long-term outcomes in each treatment, such as amount of treatment participation, income, severity of smoking, stage of change, self-efficacy, perceived health and intrinsic and extrinsic motivation to quit.
- To compare cost-savings of each treatment by modeling all additional costs of smoking for employers and smokers.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Kingston, Rhode Island, United States, 02881
- University of Rhode Island
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- smoker
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Participants will be incentivized for assessments only
|
|
|
Experimental: Incentives for Participation
Participants will be incentivized for each assessment and for each smoking cessation session they complete
|
Participants will receive three smoking cessation programs
|
|
Experimental: Incentives for Cessation
Participants will be incentivized for each assessment and biochemically confirmed abstinence at 12 and 24 months
|
Participants will have access to a smoking cessation program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Smoking abstinence
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James O Prochaska, Ph.D., University of Rhode Island
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DA034041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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