Tobacco Smoking CessationNCT02299076

Pro-Change Smoking Cessation Intervention

A study testing Behavioral economics incentives and Minimal incentives in people with Tobacco Smoking Cessation and Motivation, run by VAL Health, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether a behavioral economics solution impacts smoking cessation program engagement and quit rates. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Tobacco Smoking Cessation, Motivation
What is being tested?: Behavioral economics incentives and Minimal incentives
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 422 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2016to 1 Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Be current tobacco users (specifically smokers)
Be 18 years old or over

Who cannot join

Pregnant women

Trial locations and contacts

1 site in 1 country.

United States1 site

VAL Health
Old Greenwich, Connecticut, 06870

Other trials in United States

About this study

Official title: Software to Translate Behavioral Economics Insights to Improve Health (Phase 2b)

The purpose of this study is to determine whether a behavioral economics solution impacts smoking cessation program engagement and quit rates.

Read the detailed description

The behavioral economics solution is a weekly regret contest in which participants can win or miss out on money based on their behavior.

Conditions: Tobacco Smoking Cessation, Motivation
Being tested: Behavioral economics incentives, Minimal incentives
Keywords: Tobacco smoking cessation, Motivation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral economics incentivesBehavioural
Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention.
Minimal incentivesOther
Minimal financial incentives to promote engagement and outcomes in a smoking cessation intervention.

Study groups in NCT02299076
Study group	Role	What they receive
Usual care with minimal incentives	Other	Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study. Receives: Other: Minimal incentives
Usual care with BE incentives	Active comparator	Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study. Receives: Behavioral: Behavioral economics incentives

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Number of Completed Sessions Per Participant
Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant.
Measured: Every 30 days for up to 6 months post-enrollment
Outcome of Smoking Cessation Intervention
Quit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program.
Measured: Every 30 days for up to 6 months post-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20161 Jul 2016

First posted24 Nov 2014 (estimated)
Study start1 Jan 2016
Primary completion1 Jul 2016
Study completion1 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tobacco Smoking CessationStudies of the same condition, open and under way.
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: 422 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02299076
Sponsor's protocol ID: 5R44AG044872-03
Other IDs: 5R44AG044872-03
Status last verified: Aug 2017
First submitted: 17 Nov 2014
Last updated: 2 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be made available to other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tobacco Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Software to Translate Behavioral Economics Insights to Improve Health (Phase 2b)
ClinicalTrials.gov ID: NCT02299076
Acronym / sponsor ID: 5R44AG044872-03
Conditions: Tobacco Smoking Cessation, Motivation
Keywords: Tobacco smoking cessation, Motivation
Study type: Interventional
Recruitment status: Completed
Enrolment: 422 participants (actual)
Lead sponsor: VAL Health, LLCIndustry (pharma, biotech, devices)
Collaborators: National Institute on Aging (NIA), Rhode Island Primary Care Physicians Corporation, Pro-Change Behavior Systems
Study start: 1 Jan 2016 (actual)
Primary completion: 1 Jul 2016 (actual)
Study completion: 1 Jul 2016 (actual)
First posted: 24 Nov 2014 (estimated)
Results: Posted 2 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether a behavioral economics solution impacts smoking cessation program engagement and quit rates.

Detailed description

The behavioral economics solution is a weekly regret contest in which participants can win or miss out on money based on their behavior.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Usual care with minimal incentives	Other	Other: Minimal incentivesParticipants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.
Usual care with BE incentives	Active comparator	Behavioral: Behavioral economics incentivesParticipants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Be current tobacco users (specifically smokers)
Be 18 years old or over

Key exclusion criteria (1 listed)

Pregnant women

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
Behavioral economics incentivesBehavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention.	Behavioural	Usual care with BE incentives
Minimal incentivesMinimal financial incentives to promote engagement and outcomes in a smoking cessation intervention.	Other	Usual care with minimal incentives

Primary outcome

Average Number of Completed Sessions Per Participant
Time frame: Every 30 days for up to 6 months post-enrollment
Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant.
Outcome of Smoking Cessation Intervention
Time frame: Every 30 days for up to 6 months post-enrollment
Quit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program.

Results and safety

Results posted to the registry on 2 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care With Minimal Incentives	230	210
Usual Care With BE Incentives	226	212

Primary outcome: Average Number of Completed Sessions Per Participant

Time frame: Every 30 days for up to 6 months post-enrollment. Mean (Inter-Quartile Range). Unit: Average Number of Sessions

Measure	Usual Care With Minimal Incentives n = 210	Usual Care With BE Incentives n = 212
Value	1.633 (1 to 2)	3.052 (1 to 5)

Usual Care With Minimal Incentives vs Usual Care With BE Incentives: p <0.0001, t-test, 2 sided

Primary outcome: Outcome of Smoking Cessation Intervention

Time frame: Every 30 days for up to 6 months post-enrollment. Count of participants. Unit: Participants

Measure	Usual Care With Minimal Incentives n = 210	Usual Care With BE Incentives n = 212
Value	38	63

Adverse events

Time frame: Up to 6 months post-enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care With Minimal Incentives	0 of 210 (0%)	0 of 210 (0%)	0 of 210
Usual Care With BE Incentives	0 of 212 (0%)	0 of 212 (0%)	0 of 212

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.

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Enrolling by invitationObservational study
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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.

Karen Horgan, MBA principal investigator

President

Kevin Volpp, MD, PhD study director

Scientific Advisory Board

David Asch, MD study director

Scientific Advisory Board

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral economics incentives and Minimal incentives in people with Tobacco Smoking Cessation and Motivation, run by VAL Health, LLC at 1 site in United States.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Average Number of Completed Sessions Per Participant (time frame: Every 30 days for up to 6 months post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02299076.

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 2 Oct 2017.