Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology

Tobacco Use Cessation Clinical Trial

Official title:

Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172623
• Other study ID #: 2000024740
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.

Description:

The goals of this project include evaluating the feasibility, acceptability, and helpfulness of the real-time smoking intervention and to assess the preliminary efficacy of the real-time intervention as an adjunct to standard tobacco treatment. Rates of adherence, participant satisfaction, and perceived usefulness will be evaluated through post-treatment interviews and ratings. Biochemically confirmed 7-day point prevalence abstinence will be compared between the experimental and control groups at the end of treatment (week 8).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 or older

• Able to read English

• Cigarette smoker

• Seeking smoking cessation treatment

Exclusion Criteria:

• Serious psychiatric or medical condition

• Unable or unwilling to complete study protocol

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• Real-Time Smoking Intervention
Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
• Standard Treatment
Adult smokers will receive standard outpatient tobacco treatment.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Patterson Trust Mentored Research Award: Clinical, Health Services and Policy Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cigarettes	Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups.	Baseline and Week 8
Secondary	% Days Abstinent From Cigarettes	Timeline follow-back data will be collected to determine the % of days abstinent from cigarettes.	Week 8