Quit Smoking Text Message Study

Smoking Cessation Clinical Trial

Official title:

Evaluating Digital Health Interventions To Promote Smoking Cessation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111755
• Other study ID #: 2000035868
• Secondary ID: IA-1049344
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: Kathleen A Garrison, PhD
• Phone: 203-737-6232
• Email: kathleen.garrison[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.

Description:

Aim 1 of this study is to test within-treatment effects for smoking cessation. The primary outcome will be biochemically (cotinine)-confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks). Secondary outcomes will be percent days smoke-free, time to relapse, and rated treatment satisfaction.

Aim 2 of this study is to explore sex/gender differences in treatment effects for smoking cessation. Given established sex/gender differences in smoking behavior and cessation,randomization will be stratified by sex/gender and we will measure effects of sex/gender on outcomes. Effect sizes will be estimated for smoking outcomes by sex.

Outcomes will be evaluated for those who complete enrollment, defined as those who complete study onboarding.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• daily smokers for at least 6 months

• report an interest in quitting smoking.

Exclusion Criteria:

• reporting being currently enrolled in another quit smoking program

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• SmokefreeTXT
National Cancer Institute's SmokefreeTXT is a text message quit smoking program available nationally. Users sign up and choose a target quit date that is within 2 weeks of their signup date. Users receive 3-5 text messages per day for up to 2 weeks pre-quit and 6 weeks post-quit. The quit date can be reset as often as needed by the user.

Device:
• Smartband
A smartband that will track smoking in real-time and ask the individual to confirm/deny smoking. Participants will be asked to wear the smartband during their waking hours and to charge it overnight.

Locations

Country	Name	City	State
United States	National online recruitment	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Lung Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)	7-day PPA at end of treatment with be confirmed via cotinine testing in saliva	8 weeks
Secondary	Change in cigarettes smoked per day	Change in average number cigarettes smoked per day by self report	baseline, 4 weeks and 8 weeks
Secondary	Percent days smoke-free	Percentage of smoke-free days by self report	up to 8 weeks
Secondary	Average number of days to relapse	Relapse is defined as 7 consecutive days of smoking after quitting and will be measured using self-report or smartband detection. This will be assessed after their quit date.	2 weeks post quit date
Secondary	Treatment satisfaction assessed using the User Burden Scale	User burden scale: User burden will be assessed using items on a 5 point Likert scale with scores from 0 (not at all/never) to 4 (extremely/all of the time). Means will be reported for 6 subscales (difficulty of use, physical, time and social, mental and emotional, privacy, financial) and an overall scale range 0 to 80, with higher scores indicating more user burden.	up to 8 weeks
Secondary	Treatment satisfaction assessed using the System Usability Scale	System usability scale: Uses 10 items ranked from 1 (strongly disagree) to 5 (strongly agree) with a total score 0-100 with higher score indicating better system usability.	up to 8 weeks
Secondary	Treatment satisfaction assessed using the Mobile Application Rating Scale User version	This 20-item scale uses 5-point multiple choice ratings and has 6 subscales. Scores are reported as: 1) mean app quality, which is the mean score for the 4 subscales engagement, functionality, aesthetics, information quality; 2) mean of the app subjective quality subscale, and 3) mean of the perceived impact subscale. Higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact. Mean scores range 1-5, with higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact.	up to 8 weeks
Secondary	Treatment satisfaction assessed using the Acceptability of Intervention Measure	Acceptability of Intervention Measure includes three scales for Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each measure includes 4 items rated on a 5-point Likert scale from "completely disagree" to "completely agree" and average subscale responses are reported (out of 5) with higher scores indicating greater acceptability, appropriateness, or feasibility.	up to 8 weeks