Adapt2Quit - An Adaptive Motivational System for Socio-Economically Disadvantaged Smokers (A2Q)

Adapt2Quit - A Machine-Learning, Adaptive Motivational System: RCT for Socio-Economically Disadvantaged Smokers

The goal of this research is to test the Adapt2Quit computer program that uses participant input (message rating on how much the text motivational message might influence one to quit smoking) to select and text motivational messages that are more likely to help a user stop smoking. This Adapt2Quit system will be compared with a quitline facilitation-only control (text messages will be sent to facilitate quitline use). The primary research hypothesis is that the Adapt2Quit recommender-selected messages will be more effective than a texting quitline facilitation-only control for smoking cessation among socioeconomically disadvantaged (SED) smokers.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Smoking
• Intervention / Treatment: Behavioral: Adapt2Quit; Behavioral: Control

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ariana Kamberi, MBA; Phone Number: 508-856-8945; Email: Ariana.Kamberi@umassmed.edu
• Study Contact Backup: Name: Reem M Najjar; Phone Number: 774-275-0890; Email: Reem.Najjar@umassmed.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Not yet recruiting
      • Johns Hopkins University
      • Contact: GK Gauvey-Kern, MS; Phone Number: 774-275-0890; Email: mgauvey1@jhmi.edu
      • Principal Investigator: Daniel E Ford, MD, MPH
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Not yet recruiting
      • Baystate Health
      • Contact: Julianna Eve, MS; Phone Number: 413-794-6610; Email: Julianna.Eve@baystatehealth.org
      • Principal Investigator: Peter Lindenauer, MD, MSc
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • University of Massachusetts Medical School
      • Contact: Ariana Kamberi; Phone Number: 508-856-8945; Email: ariana.kamberi@umassmed.edu
      • Principal Investigator: Rajani Sadasivam, PhD
      • Contact: Reem M Najjar; Phone Number: 774-275-0890; Email: Reem.Najjar@umassmed.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Current smoker
• Socioeconomically disadvantaged (SED) (using the following criteria: unemployed or underemployed, low income as defined by the federal poverty level guidelines, uninsured or underinsured, and/or have less than a high school education)
• English-speaking
• Active in care (at least two clinical visits in the last year)
• Have a texting-enabled cell phone

Exclusion Criteria:

• Not a current smoker
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners
• Pregnant women
• Pilot study participants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adapt2Quit; These participants will receive Adapt2Quit motivational messaging and quitline facilitation messaging for 6 months.	Behavioral: Adapt2Quit; Motivational text messages and quitline facilitation text messages will be sent to participants; these participants will receive Adapt2Quit (experimental) messages as well as quitline facilitation messages.
Active Comparator: Control; These participants will receive quitline facilitation-only messaging for 6 months.	Behavioral: Control; Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Participant Tobacco Cessation Rate (quit rate)	Self-reported 6-month point prevalence cessation (yes/no) will be assessed at 6-month follow-up.	6-months post-randomization
Biochemical Carbon Monoxide (CO) Verification of Tobacco Cessation	Biochemical carbon monoxide (CO) verification testing will also be done for a small subset of participants, where 0-6 parts per million (PPM) measures a non-smoker and 7+ PPM indicates a current smoker.	6-months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Quit Attempt	Self-reported date of first quit attempt since starting the study will be assessed through text message response from participant during the 6-month intervention period.	From randomization to 6-months post-randomization

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Johns Hopkins University; National Cancer Institute (NCI); National Institutes of Health (NIH); Baystate Health
• Investigators: Principal Investigator: Rajani Sadasivam, PhD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H00018991; 1R01CA240551-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No