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

February 9, 2023 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
Behavioral: Standard Treatment
Adult smokers will receive standard outpatient tobacco treatment.
ACTIVE_COMPARATOR: Standard Treatment
Adult smokers will receive standard outpatient tobacco treatment.
Behavioral: Standard Treatment
Adult smokers will receive standard outpatient tobacco treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% Days Abstinent From Cigarettes
Time Frame: Week 8
Timeline follow-back data will be collected to determine the % of days abstinent from cigarettes.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Patterson Trust Mentored Research Award: Clinical, Health Services and Policy Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2019

Primary Completion (ACTUAL)

January 31, 2022

Study Completion (ACTUAL)

January 31, 2022

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (ACTUAL)

November 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2000024740

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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