- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03538678
Just Kwit: Mobile Intervention for Tobacco Cessation
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- UPMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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