Pro-Change Smoking Cessation Intervention

NCT02299076 | Completed Results

• 1 other identifier: 5R44AG044872-03
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Smoking Cessation; Motivation

Keywords

Tobacco smoking cessation; Motivation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Every 30 days for up to 6 months post-enrollment

Study Arms (2)

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.

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.

Behavioral: Behavioral economics incentives

Interventions

Behavioral economics incentives BEHAVIORAL

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

Usual care with BE incentives

Minimal incentives OTHER

Minimal financial incentives to promote engagement and outcomes in a smoking cessation intervention.

Usual care with minimal incentives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• VAL Health, LLC: lead
• National Institute on Aging (NIA): collaborator
• Rhode Island Primary Care Physicians Corporation: collaborator
• Pro-Change Behavior Systems: collaborator

Study Sites (1)

VAL Health

Old Greenwich, Connecticut, 06870, United States

Location

Results Point of Contact

• Title: Daniel Astrachan
• Organization: VAL HEALTH, LLC

dastrachan@valhealth.com

2033769388

Study Officials

• Karen Horgan, MBA

  President

  PRINCIPAL INVESTIGATOR

• Kevin Volpp, MD, PhD

  Scientific Advisory Board

  STUDY DIRECTOR

• David Asch, MD

  Scientific Advisory Board

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 24, 2014
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 2, 2017
• Results First Posted: October 2, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)