Smoking CessationNCT01569477
Striving to Quit-Wisconsin Tobacco Quit Line
A study testing Incentives for abstinence and treatment engagement and Attendance incentive in people with Smoking Cessation and Smoking, run by University of Wisconsin, Madison.
Trial summary
This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates when they are offered to Medicaid BadgerCare Plus members. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Nicotine Dependence
- What is being tested?
- Incentives for abstinence and treatment engagement and Attendance incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- enrollment in Wisconsin Medicaid (BadgerCare Plus)
- resides in study area (one of 25 counties)
- member of participating HMOs
- 18 or older
- English speaking
- has smoked daily (at least 5 cigarettes each day) over the last week
- willingness to attend visits at his/her PCC (primary care clinic) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls
- willingness to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.
Who cannot join
- not enrolled in Wisconsin Medicaid (BadgerCare Plus)
- not reside in study area
- not a member participating HMOs
- less than 18 years of age
- not English speaking
- does not smoke daily (at least 5 cigarettes each day) over the last week
- not willing to attend visits at his/her PCC (primary care clinic) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls.
- not willing to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.
About this study
Official title: Striving to Quit: Wisconsin Tobacco Quit Line Tobacco Cessation Research
This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates when they are offered to Medicaid BadgerCare Plus members.
Read the detailed description
Aim 1: To determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of smoking cessation . Participants will be BadgerCare Plus tobacco users who enroll in Wisconsin Tobacco Quit Line (WTQL) services.
Aim 2: To determine the extent to which treatment incentives vs. attendance incentives increase rates of engagement in smoking cessation treatment through the WTQL when offered to BadgerCare Plus members who smoke.
Aim 3: To determine the cost-effectiveness of the smoking cessation program when paired with treatment incentives and when paired with attendance incentives.
Aim 4: To identify moderating and mediational effects regarding the clinical benefit of incentivized smoking treatment
Aim 5: To determine the reach of an incentivized smoking cessation treatment that depends upon primary care clinic staff, a fax-to-quit referral mechanism and a state quit line.
- Conditions
- Smoking Cessation, Smoking, Nicotine Dependence
- Being tested
- Incentives for abstinence and treatment engagement, Attendance incentive
- Medical subject headings
- Smoking Cessation, Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentives for abstinence and treatment engagementBehavioural
Treatment incentives - incentives for biochemical verification visits, treatment engagement and abstinence
Attendance incentiveBehavioural
Attendance Incentives - incentives for only attending the biochemical verification visits
| Study group | Role | What they receive |
|---|---|---|
| Treatment incentives | Experimental | Incentives for biochemical verification visits, treatment engagement, and abstinence Receives: Behavioral: Incentives for abstinence and treatment engagement |
| Attendance incentive | Active comparator | Incentives for only attending the biochemical verification visits Receives: Behavioral: Attendance incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence from smoking
The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)
Measured: Measured 6 months after enrollment at follow-up assessment
Secondary outcomes (2)
Engagement in treatment
The primary analyses will compare number of calls completed
Measured: Measured 12 months after enrollment at follow-up assessment
Cost-effectiveness
The primary analysis will contrast the incremental costs of the treatment vs. attendance conditions by computing the Incremental Cost-Effectiveness Ratio (ICER) with regard to attaining 6-month abstinence.
Measured: Measured 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013
Why it stopped: Not able to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy B Baker, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569477
- Sponsor's protocol ID
- 2012-0198
- Status last verified
- Dec 2016
- First submitted
- 30 Mar 2012
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Striving to Quit: Wisconsin Tobacco Quit Line Tobacco Cessation Research
- ClinicalTrials.gov ID
- NCT01569477
- Acronym / sponsor ID
- 2012-0198
- Conditions
- Smoking Cessation, Smoking, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates when they are offered to Medicaid BadgerCare Plus members.
Detailed description
Aim 1: To determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of smoking cessation . Participants will be BadgerCare Plus tobacco users who enroll in Wisconsin Tobacco Quit Line (WTQL) services.
Aim 2: To determine the extent to which treatment incentives vs. attendance incentives increase rates of engagement in smoking cessation treatment through the WTQL when offered to BadgerCare Plus members who smoke.
Aim 3: To determine the cost-effectiveness of the smoking cessation program when paired with treatment incentives and when paired with attendance incentives.
Aim 4: To identify moderating and mediational effects regarding the clinical benefit of incentivized smoking treatment
Aim 5: To determine the reach of an incentivized smoking cessation treatment that depends upon primary care clinic staff, a fax-to-quit referral mechanism and a state quit line.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment incentives | Experimental | Behavioral: Incentives for abstinence and treatment engagementIncentives for biochemical verification visits, treatment engagement, and abstinence |
| Attendance incentive | Active comparator | Behavioral: Attendance incentiveIncentives for only attending the biochemical verification visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- enrollment in Wisconsin Medicaid (BadgerCare Plus)
- resides in study area (one of 25 counties)
- member of participating HMOs
- 18 or older
- English speaking
Key exclusion criteria (8 listed)
- not enrolled in Wisconsin Medicaid (BadgerCare Plus)
- not reside in study area
- not a member participating HMOs
- less than 18 years of age
- not English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentives for abstinence and treatment engagementTreatment incentives - incentives for biochemical verification visits, treatment engagement and abstinence | Behavioural | Treatment incentives |
| Attendance incentiveAttendance Incentives - incentives for only attending the biochemical verification visits | Behavioural | Attendance incentive |
Primary outcome
Abstinence from smoking
Time frame: Measured 6 months after enrollment at follow-up assessment
The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)
2 secondary outcomes
Engagement in treatment
Time frame: Measured 12 months after enrollment at follow-up assessment
Cost-effectiveness
Time frame: Measured 12 months after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy B Baker, PhD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing Incentives for abstinence and treatment engagement and Attendance incentive in people with Smoking Cessation and Smoking, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence from smoking (time frame: Measured 6 months after enrollment at follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.