An interventional study of Kwit smartphone app in Smoking Cessation, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Basic science
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.
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.
University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of Kwit smartphone app
Other: Kwit smartphone app
Patient initiated follow-up post discharge
Kwit smarphone app
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?
Time frame: 1-month
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.
Time frame: 1-month
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?
Time frame: 1-month
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)?
Time frame: 1-month
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)?
Time frame: 1-month
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?
Time frame: 1-month
| Milestone | Kwit App | Standard of Care |
|---|---|---|
| Started | 20 | 20 |
| Completed | 5 | 9 |
| Not completed | 15 | 11 |
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?
| Participants | Kwit App | Standard of Care |
|---|---|---|
| App helpful — Very | 2 | — |
| App helpful — Somewhat | 2 | — |
| App helpful — Neutral | 1 | — |
| App helpful — Not very | 0 | — |
| App helpful — Not at all | 0 | — |
| App easy to use — Very | 3 | — |
| App easy to use — Somewhat | 2 | — |
| App easy to use — Neutral | 0 | — |
| App easy to use — Not very | 0 | — |
| App easy to use — Not at all | 0 | — |
| App frustrating to use — Very | 0 | — |
| App frustrating to use — Somewhat | 1 | — |
| App frustrating to use — Neutral | 0 | — |
| App frustrating to use — Not very | 2 | — |
| App frustrating to use — Not at all | 2 | — |
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.
| Participants | Kwit App | Standard of Care |
|---|---|---|
| Almost everyday | 0 | — |
| Several days/week | 2 | — |
| Several days/month | 3 | — |
| Not at all | 0 | — |
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?
| Participants | Kwit App | Standard of Care |
|---|---|---|
| Smoke since leaving hospital — Yes | 4 | 8 |
| Smoke since leaving hospital — No | 1 | 1 |
| Smoke since leaving hospital — Don't know | 0 | 0 |
| Smoke since leaving hospital — Did not answer | 0 | 0 |
| Smoke past 30 days — Yes | 3 | 8 |
| Smoke past 30 days — No | 0 | 0 |
| Smoke past 30 days — Don't know | 1 | 0 |
| Smoke past 30 days — Did not answer | 1 | 1 |
| Smoke past 7 days — Yes | 4 | 5 |
| Smoke past 7 days — No | 0 | 3 |
| Smoke past 7 days — Don't know | 0 | 0 |
| Smoke past 7 days — Did not answer | 1 | 1 |
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)?
| Cigarettes smoked | Kwit App | Standard of Care |
|---|---|---|
| Cessation--cigarettes Smoked | 4.67 ± 0.58 | 8.14 ± 5.49 |
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)?
| Days | Kwit App | Standard of Care |
|---|---|---|
| Cessation--days Smoked | 21.67 ± 7.64 | 17.67 ± 12.97 |
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?
| Participants | Kwit App | Standard of Care |
|---|---|---|
| Not at all confident | 1 | 1 |
| A little confident | 0 | 0 |
| Somewhat confident | 1 | 3 |
| Fairly confident | 1 | 2 |
| Very confident | 1 | 1 |
| Don't know | 0 | 0 |
| Refuse to answer | 0 | 0 |
| N/A | 0 | 1 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kwit App | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Standard of Care | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Customized(Participants) | Kwit App | Standard of Care | Total |
|---|---|---|---|
| <18 | 0 | 0 | 0 |
| >=18 and <=30 | 20 | 20 | 40 |
| >30 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Kwit App | Standard of Care | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 10 | 10 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Kwit App | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 20 | 20 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Kwit App | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 3 | 8 |
| White | 13 | 16 | 29 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Kwit App | Standard of Care | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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