Smoking CessationNCT03538678
Just Kwit: Mobile Intervention for Tobacco Cessation
A study testing Kwit smartphone app in people with Smoking Cessation, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Kwit smartphone app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 29 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-30 smokers interested in cessation (>5 cigarettes/day over the past 30 days)
- Must own an Apple or Android based smartphone.
Who cannot join
- Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Kwit smartphone app
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kwit smartphone appOther
Kwit smarphone app
| Study group | Role | What they receive |
|---|---|---|
| Kwit app | Experimental | Use of Kwit smartphone app Receives: Other: Kwit smartphone app |
| Standard of care | No intervention | Patient initiated follow-up post discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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.
Measured: 1-month
Secondary outcomes (4)
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?
Measured: 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)?
Measured: 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)?
Measured: 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?
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start11 Jun 2018
- Primary completion29 Dec 2019
- Study completion29 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kar-Hai Chu, University of Pittsburgh
- Investigators
- Kar-Hai Chu, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538678
- Sponsor's protocol ID
- PRO18010454
- Other IDs
- K07CA222338
- Status last verified
- Feb 2021
- First submitted
- 14 Apr 2018
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30808389
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Just Kwit: Mobile Intervention for Tobacco Cessation
- ClinicalTrials.gov ID
- NCT03538678
- Acronym / sponsor ID
- PRO18010454
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 29 Dec 2019 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 18 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kwit app | Experimental | Other: Kwit smartphone appUse of Kwit smartphone app |
| Standard of care | No intervention | –Patient initiated follow-up post discharge |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-30 smokers interested in cessation (>5 cigarettes/day over the past 30 days)
- Must own an Apple or Android based smartphone.
Key exclusion criteria (1 listed)
- Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kwit smartphone appKwit smarphone app | Other | Kwit app |
Primary outcome
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?
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.
4 secondary outcomes
Cessation--point Prevalence Abstinence
Time frame: 1-month
Cessation--cigarettes Smoked
Time frame: 1-month
Cessation--days Smoked
Time frame: 1-month
Cessation--confidence
Time frame: 1-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30808389Chu 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.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kar-Hai Chu, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kwit smartphone app in people with Smoking Cessation, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App (time frame: 1-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.