NCT03517397

Brief Summary

Smoking prevalence rates are disproportionately high among individuals living below the poverty threshold, those living in rural areas, and Oklahomans. Nearly 1.3 million Oklahomans live in rural areas and the prevalence of poverty is elevated relative to the U.S. Our preliminary work has indicated that offering small escalating financial incentives for smoking abstinence (i.e., Contingency Management \[CM\]) dramatically increases short-term cessation rates among socioeconomically disadvantaged smokers when incentives are included as an adjunct to clinic-based smoking cessation treatment. However, other approaches are needed for socioeconomically disadvantaged individuals who are unable to attend clinic visits due to rural residence or other limitations. Internet and mobile phone-based CM approaches have been developed to reduce or eliminate the need for in-person visits. The goal of the current project is to improve upon existing mobile CM approaches by fully automating the process to make financial incentives interventions for smoking cessation feasible and accessible to individuals across the state. The aims of the proposed project are to 1) develop a fully automated, mobile phone-based CM approach to remotely verify smoking abstinence, confirm participant identity, and deliver financial incentives for smoking cessation, and 2) evaluate the feasibility and preliminary effectiveness of using fully automated mobile CM as an adjunct to telephone counseling and nicotine replacement therapy among 20 socioeconomically disadvantaged adults. The current project extends the scope of the parent study by increasing the reach of the CM approach to socioeconomically disadvantaged individuals who may be unable to attend in-person visits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

March 30, 2018

Last Update Submit

March 27, 2024

Conditions

Keywords

Smoking CessationSocioeconomic DisadvantageContingency ManagementFinancial IncentivesMobile HealthBiochemical Verification

Outcome Measures

Primary Outcomes (3)

  • Biochemically-verified smoking cessation

    Self-reported abstinence over the past 7 days in conjunction with a carbon monoxide value \< 6 ppm

    12 weeks post-quit date

  • Treatment Participants

    Treatment sessions completed (1-6)

    5 weeks post-enrollment

  • Follow-Up Completion Rate

    The number of people who provide self-reports of smoking status and biochemical verification of smoking cessation.

    12 weeks post-quit date

Secondary Outcomes (2)

  • Device Loss

    13 weeks post-enrollment

  • Completion of Ecological Momentary Assessment

    5 weeks post-enrollment

Study Arms (1)

Mobile Contingency Management

EXPERIMENTAL
Behavioral: Mobile Contingency Management

Interventions

Participants will be offered 6 counseling sessions, nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.

Mobile Contingency Management

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • currently uninsured or receiving Medicaid benefits
  • earn a score ≥ 4 on the REALM indicating \> 6th grade English literacy level
  • willing to quit smoking 7 days from their first visit
  • years of age
  • expired CO level ≥ 8 ppm suggestive of current smoking
  • currently smoking ≥ 5 cigarettes per day
  • own or have access to a computer (to remotely complete study questionnaires).

You may not qualify if:

  • pregnant or breastfeeding
  • have uncontrolled hypertension
  • had a myocardial infarction within the past two weeks
  • have an allergy to adhesive tape
  • are unwilling to use nicotine replacement therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Oklahoma Health Sciences Center, Tobacco Treatment Research Program

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • Kendzor DE, Businelle MS, Waring JJC, Mathews AJ, Geller DW, Barton JM, Alexander AC, Hebert ET, Ra CK, Vidrine DJ. Automated Mobile Delivery of Financial Incentives for Smoking Cessation Among Socioeconomically Disadvantaged Adults: Feasibility Study. JMIR Mhealth Uhealth. 2020 Apr 15;8(4):e15960. doi: 10.2196/15960.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Darla E. Kendzor, PhD

    The University of Oklahoma Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2018

First Posted

May 7, 2018

Study Start

August 15, 2018

Primary Completion

May 15, 2019

Study Completion

May 15, 2019

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations