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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04839198

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

24.9

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: Android Wear smartwatch Behavioral: Adaptive Treatment Drug: Nicotine Patch Behavioral: interviewing-based counseling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adaptive Treatment plus usual care	Behavioral: Android Wear smartwatch All participants will wear an Android Wear smartwatch, and will complete ecological momentary assessments (EMA). Behavioral: Adaptive Treatment 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. Drug: Nicotine Patch 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) Behavioral: interviewing-based counseling 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.
Active Comparator: Usual care	Behavioral: Android Wear smartwatch All participants will wear an Android Wear smartwatch, and will complete ecological momentary assessments (EMA). Drug: Nicotine Patch 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) Behavioral: interviewing-based counseling 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.

Arm

Intervention/Treatment

Experimental: Adaptive Treatment plus usual care

Behavioral: Android Wear smartwatch

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

Behavioral: Adaptive Treatment

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.

Drug: Nicotine Patch

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)

Behavioral: interviewing-based counseling

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.

Active Comparator: Usual care

Behavioral: Android Wear smartwatch

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

Drug: Nicotine Patch

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)

Behavioral: interviewing-based counseling

Outcome Measures

Primary Outcome Measures

Number of patients who quit smoking as confirmed by absence of salivary cotinine [4-weeks after quit day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

currently smoking less than 5 cigarettes per day

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

Principal Investigator: Emily Hebert, DrPH, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emily Hebert, Assistant Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT04839198

Other Study ID Numbers:

HSC-SPH-20-1159
R00DA046564

First Posted:

Apr 9, 2021

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Emily Hebert, Assistant Professor, The University of Texas Health Science Center, Houston

Nicotine patch

Additional relevant MeSH terms:

Nicotine

Study Results

No Results Posted as of Sep 28, 2021