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Clinical Trials/NCT04172623
NCT04172623CompletedNot Applicable

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

Yale University1 site in 1 country58 target enrollmentStarted: June 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
1
Primary Endpoint
Change in Cigarettes

Study Overview

Brief 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.

Detailed 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Real-Time Smoking Intervention

Experimental

Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.

Intervention: Real-Time Smoking Intervention (Behavioral)

Real-Time Smoking Intervention

Experimental

Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.

Intervention: Standard Treatment (Behavioral)

Standard Treatment

Active Comparator

Adult smokers will receive standard outpatient tobacco treatment.

Intervention: Standard Treatment (Behavioral)

Outcomes

Primary Outcomes

Change in Cigarettes

Time Frame: Baseline and Week 8

Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups.

Secondary Outcomes

  • % Days Abstinent From Cigarettes(Week 8)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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