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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04172623
Collaborator
Patterson Trust Mentored Research Award: Clinical, Health Services and Policy Research (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Real-Time Smoking Intervention
  • Behavioral: Standard Treatment
N/A

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
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel group randomized trial design comparing smoking outcomes when receiving standard treatment vs. standard treatment plus real-time smoking intervention.Parallel group randomized trial design comparing smoking outcomes when receiving standard treatment vs. standard treatment plus real-time smoking intervention.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Jan 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Rates of adherence to the smartband intervention [Week 8]

    Measured as the number of days wearing the smartband

  2. Patient satisfaction [Week 8]

    Self-reported patient satisfaction subjective ratings of the real-time intervention will use a scale created specifically for this study to assess the intervention. The 7 item scale uses a 5 point Likert scale and the sum total would indicate level of satisfaction. The highest score of 35, would indicate the highest level of satisfaction.

Secondary Outcome Measures

  1. Abstinence from cigarettes [Week 8]

    Self-reported cigarette use (Timeline follow-back data) confirmed with CO≤ 4ppm during the last week of the study to estimate effect sizes between groups.

  2. Number of days abstinent from cigarettes [Week 4]

    Timeline follow-back data will be collected to determine the number of days abstinent from cigarettes.

  3. Number of days abstinent from cigarettes [Week 8]

    Timeline follow-back data will be collected to determine the number of days abstinent from cigarettes.

  4. Changes in cigarettes per smoking day from baseline [Week 4]

    Timeline follow-back data will be collected to determine the changes in the number of cigarettes smoked per day.

  5. Changes in cigarettes per smoking day from baseline [Week 8]

    Timeline follow-back data will be collected to determine the changes in the number of cigarettes smoked per day.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University New Haven Connecticut United States 06511

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Krysten Bold, Ph.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04172623
Other Study ID Numbers:
  • 2000024740
First Posted:
Nov 21, 2019
Last Update Posted:
Jun 11, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 11, 2021