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

NCT ID: NCT04172623

Last Updated: 2023-02-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2022-01-31

Brief Summary

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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

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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).

Conditions

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Tobacco Use Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group randomized trial design comparing smoking outcomes when receiving standard treatment vs. standard treatment plus real-time smoking intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Real-Time Smoking Intervention

Intervention Type BEHAVIORAL

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

Standard Treatment

Intervention Type BEHAVIORAL

Adult smokers will receive standard outpatient tobacco treatment.

Standard Treatment

Adult smokers will receive standard outpatient tobacco treatment.

Group Type ACTIVE_COMPARATOR

Standard Treatment

Intervention Type BEHAVIORAL

Adult smokers will receive standard outpatient tobacco treatment.

Interventions

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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.

Intervention Type BEHAVIORAL

Standard Treatment

Adult smokers will receive standard outpatient tobacco treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krysten Bold, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2000024740

Identifier Type: -

Identifier Source: org_study_id

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