Just Kwit: Mobile Intervention for Tobacco Cessation

February 1, 2021 updated by: Kar-Hai Chu, University of Pittsburgh
The intervention will be use of a smartphone app to support tobacco cessation. The app's main features include sending motivational messages, displaying money saved, and allowing the user to log cravings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will recruit hospitalized young adult smokers aged 18-30 interested in cessation over a six-month period. Patients will all receive a UPMC Tobacco Treatment Service counseling session focused on motivational interviewing prior to participation in the study. Upon consent, participants will then be randomized 1:1 to either standard patient-initiated follow-up or use of the Kwit app. Participants will be stratified by sex because males and females are known to have highly variable responses to existing tobacco control interventions. Investigators will systematically assess feasibility using established Likert-type items factors such as interaction, features, engagement, trust, and impact.

If a participant consents to the study, they will be given a brief survey to collect general information related to their smoking behavior. After 30 days, a follow-up survey will be conducted to assess their current smoking behavior. Participants randomized to the experimental arm will be asked additional questions about their use of the smartphone app.

Study Type

Interventional

Enrollment (Actual)

40

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

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC

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 to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-30 smokers interested in cessation (>5 cigarettes/day over the past 30 days)
  • Must own an Apple or Android based smartphone.

Exclusion Criteria:

  • Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kwit app
Use of Kwit smartphone app
Kwit smarphone app
No Intervention: Standard of care
Patient initiated follow-up post discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App
Time Frame: 1-month

Assessment of feasibility - Descriptive statistics that will be obtained via a follow up survey will be used to assess feasibility. The follow up survey will be administered one month after discharge via email, phone or in-person, determined by the preference of the participant. Specific questions will be asked asking participants to rate the Kwit smartphone application based on helpfulness, ease of use, and to list frustrations and helpful aspects of the application.

How helpful was the Kwit app? Very helpful Somewhat helpful Neutral Not very helpful Not at all helpful

Was the app easy to use? Very Somewhat Neutral Not much Not at all

Was it frustrating to use? Very Somewhat Neutral Not much Not at all

What, if anything, was helpful about the app? What, if anything, was not helpful about the app?

1-month
Feasibility - Frequency of Use
Time Frame: 1-month
Assessment of feasibility - Descriptive statistics that will be obtained via a follow up survey will be used to assess feasibility. The follow up survey will be administered one month after discharge via email, phone or in-person, determined by the preference of the participant. Specific questions will be asked asking participants to rate the Kwit smartphone application based on frequency of use.
1-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cessation--point Prevalence Abstinence
Time Frame: 1-month

Assessment of cessation - Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via a follow up survey with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation.

Since you left the hospital in (month/year), have you smoked a cigarette (even a puff)?

In the past 30 days, have you smoked a cigarette, even a puff?

In the past 7 days, have you smoked a cigarette, even a puff?

1-month
Cessation--cigarettes Smoked
Time Frame: 1-month

Assessment of cessation - Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via a follow up survey with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation.

(On the days you smoked), how many cigarettes on average did you smoke (even a puff)?

1-month
Cessation--days Smoked
Time Frame: 1-month

Assessment of cessation - Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via a follow up survey with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation.

In the past 30 days, on how many days did you smoke (even a puff)?

1-month
Cessation--confidence
Time Frame: 1-month

Assessment of cessation - Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via a follow up survey with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation.

How confident are you that you will be able to stay quit?

1-month

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 11, 2018

Primary Completion (Actual)

December 29, 2019

Study Completion (Actual)

December 29, 2019

Study Registration Dates

First Submitted

April 14, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PRO18010454
  • K07CA222338 (U.S. NIH Grant/Contract)

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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