Smoking Cessation
Conditions
Brief 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.
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.
Interventions
OTHERKwit smartphone app
Kwit smarphone app
Sponsors
National Cancer Institute (NCI)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | 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? |
| Feasibility - Frequency of Use | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cessation--point Prevalence Abstinence | 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? |
| Cessation--cigarettes Smoked | 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)? |
| Cessation--days Smoked | 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)? |
| Cessation--confidence | 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? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kwit App Use of Kwit smartphone app
Kwit smartphone app: Kwit smarphone app | 20 |
| Standard of Care Patient initiated follow-up post discharge | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Kwit App | Standard of Care | Total |
|---|---|---|---|
| Age, Customized <18 | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=18 and <=30 | 20 Participants | 20 Participants | 40 Participants |
| Age, Customized >30 | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 13 Participants | 16 Participants | 29 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 1-month
Population: Only applicable for experimental arm
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kwit App | Feasibility - Frequency of Use | Not at all | 0 Participants |
| Kwit App | Feasibility - Frequency of Use | Almost everyday | 0 Participants |
| Kwit App | Feasibility - Frequency of Use | Several days/week | 2 Participants |
| Kwit App | Feasibility - Frequency of Use | Several days/month | 3 Participants |
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?
Time frame: 1-month
Population: Only applicable for experimental arm
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App helpful | Very | 2 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App helpful | Somewhat | 2 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App helpful | Neutral | 1 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App helpful | Not very | 0 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App helpful | Not at all | 0 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App easy to use | Very | 3 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App easy to use | Somewhat | 2 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App easy to use | Neutral | 0 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App easy to use | Not very | 0 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App easy to use | Not at all | 0 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App frustrating to use | Very | 0 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App frustrating to use | Somewhat | 1 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App frustrating to use | Neutral | 0 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App frustrating to use | Not very | 2 Participants |
| Kwit App | Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App | App frustrating to use | Not at all | 2 Participants |
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)?
Time frame: 1-month
Population: 4 participants (2 exp, 2 control) did not answer this question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kwit App | Cessation--cigarettes Smoked | 4.67 Cigarettes smoked | Standard Deviation 0.58 |
| Standard of Care | Cessation--cigarettes Smoked | 8.14 Cigarettes smoked | Standard Deviation 5.49 |
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?
Time frame: 1-month
Population: 2 participants (1 exp, 1 control) did not answer this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kwit App | Cessation--confidence | Not at all confident | 1 Participants |
| Kwit App | Cessation--confidence | Very confident | 1 Participants |
| Kwit App | Cessation--confidence | Somewhat confident | 1 Participants |
| Kwit App | Cessation--confidence | A little confident | 0 Participants |
| Kwit App | Cessation--confidence | Refuse to answer | 0 Participants |
| Kwit App | Cessation--confidence | Fairly confident | 1 Participants |
| Kwit App | Cessation--confidence | N/A | 0 Participants |
| Kwit App | Cessation--confidence | Don't know | 0 Participants |
| Standard of Care | Cessation--confidence | N/A | 1 Participants |
| Standard of Care | Cessation--confidence | Not at all confident | 1 Participants |
| Standard of Care | Cessation--confidence | A little confident | 0 Participants |
| Standard of Care | Cessation--confidence | Somewhat confident | 3 Participants |
| Standard of Care | Cessation--confidence | Fairly confident | 2 Participants |
| Standard of Care | Cessation--confidence | Very confident | 1 Participants |
| Standard of Care | Cessation--confidence | Don't know | 0 Participants |
| Standard of Care | Cessation--confidence | Refuse to answer | 0 Participants |
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)?
Time frame: 1-month
Population: 5 participants (2 exp, 3 control) did not answer this question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kwit App | Cessation--days Smoked | 21.67 Days | Standard Deviation 7.64 |
| Standard of Care | Cessation--days Smoked | 17.67 Days | Standard Deviation 12.97 |
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?
Time frame: 1-month
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Kwit App | Cessation--point Prevalence Abstinence | Smoke since leaving hospital | Yes | 4 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke since leaving hospital | No | 1 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke since leaving hospital | Don't know | 0 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke since leaving hospital | Did not answer | 0 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke past 30 days | Yes | 3 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke past 30 days | No | 0 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke past 30 days | Don't know | 1 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke past 30 days | Did not answer | 1 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke past 7 days | Yes | 4 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke past 7 days | No | 0 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke past 7 days | Don't know | 0 Participants |
| Kwit App | Cessation--point Prevalence Abstinence | Smoke past 7 days | Did not answer | 1 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke past 7 days | Don't know | 0 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke since leaving hospital | Yes | 8 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke past 30 days | Don't know | 0 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke since leaving hospital | No | 1 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke past 7 days | No | 3 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke since leaving hospital | Don't know | 0 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke past 30 days | Did not answer | 1 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke since leaving hospital | Did not answer | 0 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke past 7 days | Did not answer | 1 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke past 30 days | Yes | 8 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke past 7 days | Yes | 5 Participants |
| Standard of Care | Cessation--point Prevalence Abstinence | Smoke past 30 days | No | 0 Participants |