Automated Mobile Contingency Management for Smoking Cessation: A Pilot RCT (SCC PREVAILgo)

NCT03739437 | Terminated Results

• 2 other identifiers: 9717P30CA225520
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed project is to pilot test an automated mobile phone-based contingency management (CM) approach to tobacco (smoking) cessation. With the assistance of the Mobile Health (mHealth) shared resource at the University of Oklahoma Health Sciences Center (OUHSC) and Stephenson Cancer Center (SCC), the investigators have combined technologies including 1) low-cost carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to confirm the identity of participants while they provide a breath sample, and 3) remote delivery of incentives automatically triggered by biochemical confirmation of self-reported smoking abstinence. This automated, mobile CM approach will be evaluated in a randomized controlled pilot trial of 40 socioeconomically disadvantaged males and females seeking smoking cessation treatment. Participants will be randomly assigned to telephone counseling plus nicotine replacement therapy (standard care \[SC\]) or SC plus a 12-week mobile financial incentives intervention (CM) for biochemically-confirmed abstinence. Participants will be followed for 12 weeks after a scheduled quit attempt to assess smoking status.

Conditions

Smoking Cessation

Keywords

automated; smoking cessation; socioeconomic disadvantage; contingency management; financial incentives; mobile health; biochemical verification

Outcome Measures

Primary Outcomes (2)

• Self-Reported Smoking Cessation

  Self-reported smoking abstinence during the past 7 days days

  13 weeks post-enrollment

• Completion of Breath Sample Submissions

  The percentage of total possible smartphone-based breath sample submissions completed over 13 weeks.

  13 weeks post-enrollment

Secondary Outcomes (2)

• Loss of Smartphones

  13 weeks post-enrollment

• Loss of iCO Sensors

  13 weeks post-enrollment

Study Arms (2)

Mobile Contingency Management

EXPERIMENTAL

Behavioral: Mobile Contingency Management; Behavioral: Standard Care

Standard Care

ACTIVE COMPARATOR

Behavioral: Standard Care

Interventions

Mobile Contingency Management BEHAVIORAL

Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of 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

Standard Care BEHAVIORAL

Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).

Mobile Contingency Management; Standard Care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

1. annual Household income of \< 200% of the federal poverty threshold (i.e., low-income) given household size 2. earn a score ≥ 4 on the REALM indicating \> 6th grade English literacy level 3. are willing to quit smoking 7 days after enrollment 4. are ≥ 18 years of age 5. currently smoke ≥ 5 cigarettes per day 6. have a CO level of \> 6 ppm 7. have no contraindications for NRT 8. willingness to complete an identity check (i.e., video conference call or provide a photo ID).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Oklahoma: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Darla Kendzor
• Organization: The University of Oklahoma Health Sciences Center

Darla-Kendzor@ouhsc.edu

(405) 271-8001

Study Officials

• Darla Kendzor, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 13, 2018
• Study Start: December 10, 2020
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: April 4, 2023
• Results First Posted: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)