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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03538678
Other study ID # PRO18010454
Secondary ID K07CA222338
Status Completed
Phase N/A
First received
Last updated
Start date June 11, 2018
Est. completion date December 29, 2019

Study information

Verified date February 2021
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 29, 2019
Est. primary completion date December 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Kwit smartphone app
Kwit smarphone app

Locations

Country Name City State
United States UPMC Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App 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
Primary Feasibility - Frequency of Use 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 Cessation--point Prevalence Abstinence 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
Secondary Cessation--cigarettes Smoked 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
Secondary Cessation--days Smoked 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
Secondary Cessation--confidence 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
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