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| ID | Type | Description | Link |
|---|---|---|---|
| K07CA222338 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kwit app | Experimental | Use of Kwit smartphone app |
|
| Standard of care | No Intervention | Patient initiated follow-up post discharge |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kwit smartphone app | Other | Kwit smarphone app |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kar-Hai Chu, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30808389 | Derived | Chu KH, Escobar-Viera CG, Matheny SJ, Davis EM, Primack BA. Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial. Trials. 2019 Feb 26;20(1):147. doi: 10.1186/s13063-019-3246-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Kwit App | Use of Kwit smartphone app Kwit smartphone app: Kwit smarphone app |
| FG001 | Standard of Care | Patient initiated follow-up post discharge |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Kwit App | Use of Kwit smartphone app Kwit smartphone app: Kwit smarphone app |
| BG001 | Standard of Care | Patient initiated follow-up post discharge |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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? | Only applicable for experimental arm | Posted | Count of Participants | Participants | 1-month |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Kwit App | Use of Kwit smartphone app Kwit smartphone app: Kwit smarphone app |
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Primary purpose of trial was to study feasibility, with limited analyses planned. With low follow-up, statistical analyses would not be appropriate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kar-Hai Chu | University of Pittsburgh | 412-692-2578 | chuk@pitt.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2019 | Feb 1, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| 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)? | 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)? | 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? | 1-month |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Kwit App |
Use of Kwit smartphone app Kwit smartphone app: Kwit smarphone app |
| OG001 | Standard of Care | Patient initiated follow-up post discharge |
|
|
| 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. | Only applicable for experimental arm | Posted | Count of Participants | Participants | 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? | Posted | Count of Participants | Participants | 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)? | 4 participants (2 exp, 2 control) did not answer this question. | Posted | Mean | Standard Deviation | Cigarettes smoked | 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)? | 5 participants (2 exp, 3 control) did not answer this question. | Posted | Mean | Standard Deviation | Days | 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? | 2 participants (1 exp, 1 control) did not answer this question. | Posted | Count of Participants | Participants | 1-month |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Standard of Care | Patient initiated follow-up post discharge | 0 | 20 | 0 | 20 | 0 | 20 |
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| Not at all |
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| Not at all |
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| Not at all |
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| Don't know |
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| Did not answer |
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| Smoke past 30 days |
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| Smoke past 7 days |
|
| Somewhat confident |
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| Fairly confident |
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| Very confident |
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| Don't know |
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| Refuse to answer |
|
| N/A |
|