Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation

NCT04839198 | Completed

• 2 other identifiers: HSC-SPH-20-1159R00DA046564
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the feasibility and preliminary effectiveness of delivering a personalized, just-in-time adaptive intervention driven by machine learning prediction of smoking lapse risk in real time.

Conditions

Smoking Cessation

Keywords

Nicotine patch

Outcome Measures

Primary Outcomes (1)

• Number of patients who quit smoking as confirmed by absence of salivary cotinine

  4-weeks after quit day

Study Arms (2)

Adaptive Treatment plus usual care

EXPERIMENTAL

Behavioral: Android Wear smartwatch; Behavioral: Adaptive Treatment; Drug: Nicotine Patch; Behavioral: interviewing-based counseling

Usual care

ACTIVE COMPARATOR

Behavioral: Android Wear smartwatch; Drug: Nicotine Patch; Behavioral: interviewing-based counseling

Interventions

Android Wear smartwatch BEHAVIORAL

All participants will wear an Android Wear smartwatch, and will complete ecological momentary assessments (EMA).

Adaptive Treatment plus usual care; Usual care

Adaptive Treatment BEHAVIORAL

Participants will have access to a "Dashboard" button in the InsightTM app that displays personalized statistics based on their progress and patterns in the study.The dashboard will update as more data is collected about the participant's smoking habits, starting in the pre-quit period and continuing through the post-quit period. Second, in the post-quit period, participants will receive treatment messages when the machine learning algorithm determines that they are at high risk for lapse.At the follow-up visit, participants will complete a survey to evaluate what they liked and disliked about the intervention, how accurate they thought the app was in predicting their risk, and how useful they found the dashboard.

Adaptive Treatment plus usual care

Nicotine Patch DRUG

At Visit 2, participants will be asked to begin their attempt to quit smoking and will receive a 12-week supply of nicotine replacement therapy (i.e., nicotine patches and gum)

Adaptive Treatment plus usual care; Usual care

interviewing-based counseling BEHAVIORAL

At Visit 2, participants will be asked to begin their attempt to quit smoking and meet with a Tobacco Treatment Specialist, who will provide motivational interviewing-based counseling, help the participants develop a quit plan, and discuss relapse prevention. During the 6-weeks of the study, participants will have the option of attending up to 6 counseling sessions with the Tobacco Treatment Specialist, either in-person or via phone or web.

Adaptive Treatment plus usual care; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a score greater than or equal to 4 on the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM-SF),12
• willingness to quit smoking 14 days after the baseline visit
• no contraindications to using Nicotine replacement therapy (NRT).
• If participants would like to use their own phone to complete the EMAs, they must additionally have an Android smartphone (Android 5.2 or higher), and be willing to install the InsightTM mHealth app on their phone.

You may not qualify if:

• currently smoking less than 5 cigarettes per day

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Emily Hebert, DrPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: February 6, 2024
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: March 28, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)