Incentives for Participation Versus Outcomes

Smoking Clinical Trial

Official title:

Incentives for Participation Versus Outcomes for Population Cessation of Smoking

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01826331
• Other study ID #: DA034041
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2014
• Est. completion date: May 2019

Study information

• Verified date: May 2019
• Source: University of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of the most important debates in the field of disease prevention is whether financial incentives should be contingent on participation in evidence-based programs for smoking cessation or on actual outcomes, like prolonged abstinence. This study can fill a major knowledge gap in this debate, which is the lack of any population trial that compared the impacts of outcomes- and participation-based incentives in a population of smokers. This research can help policy makers and health service providers choose the incentives approach that provides the most effectiveness, cost-effectiveness and cost-savings for entire populations of smokers.

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:

1. To assess whether the treatment group incentivized for participation outperforms the control group at 12, 24 and 36 months as hypothesized;

2. 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;

3. To assess whether the treatment group incentivized for participation outperforms the treatment group incentivized for outcomes at 36 months as hypothesized.

4. To compare the cost-effectiveness of each treatment in a population of mostly unmotivated smokers;

The Secondary Aims are:

1. 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.

2. 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.

3. To compare cost-savings of each treatment by modeling all additional costs of smoking for employers and smokers.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 880
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• smoker

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Incentives for Participation
Participants will receive three smoking cessation programs
• Incentives for Cessation
Participants will have access to a smoking cessation program

Locations

Country	Name	City	State
United States	University of Rhode Island	Kingston	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
University of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence		24 months