SmokingNCT02955095
Usability and Pilot Testing - Intervention for Smoking Cessation
A study testing Quit Smoking Phone Application in people with Smoking and Smoking Cessation, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of the usability and pilot testing for the project "Developing a Bi-national Buddy Intervention for Smoking Cessation and Cultural Education" is to better understand how users interact with the smoking cessation app, and to improve the product based on the results. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Quit Smoking Phone Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2018to 2 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current student
- Current cigarette smoker (smoked in past 30 days)
- speak English
- Own a smartphone
- Has some interest in quitting smoking.
Who cannot join
- Not meeting inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The purpose of the usability and pilot testing for the project "Developing a Bi-national Buddy Intervention for Smoking Cessation and Cultural Education" is to better understand how users interact with the smoking cessation app, and to improve the product based on the results. In pilot testing the smoking cessation app the investigators will examine the feasibility of our approach. The usability testing portion of the study is intended primarily to improve on the design of the smoking cessation app, and will: gather quantitative data on participant's performance, identify usability problems, and determine user satisfaction with the app. The pilot testing portion of the study will evaluate the feasibility, time, cost and statistical variability in an attempt to predict an appropriate sample size and improve upon the study design prior to performance of a full-scale research study.
Objective 1:To collect quantitative data on participant's performance while using the app for smoking cessation.
Read more
Objective 2:To identify problems with usability of the smoking cessation buddy app.
Objective 3:To assess user satisfaction with the smoking cessation buddy app. Objective 4:To improve upon the design of the smoking cessation buddy app Objective 5:To assess the feasibility, time, cost, and statistical variability for a full-scale implementation of this study with the intervention group.
Read the detailed description
Tobacco use cessation among youth is not adequately addressed in the US and Russia. The proposed intervention utilizes an innovative evidence-based approach while addressing the shortcomings of prior individual intervention components. In this project, investigators seek to refine a smoking cessation app by conducting two rounds of usability testing followed by a pilot test of the final app, to access usability problems, user satisfaction, and user-friendliness. This data will be collected in a de-identified and confidential manner, and will then be analyzed and used to refine the final app that will later be used.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Quit Smoking Phone Application
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit Smoking Phone ApplicationDevice
The app will be downloaded on participants' phones, and used by the participant for 30 days to make a quit attempt. Participants will be encouraged to use the app every day and to utilize all of its features, including features such as setting a quit date, taking the assessment section, and entering cigarette use and reasons for cravings
| Study group | Role | What they receive |
|---|---|---|
| Current cigarette smoker | Experimental | Not described Receives: Device: Quit Smoking Phone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarettes smoked per day
Measured: 30 Days
How many times the app is accessed,
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start2 Aug 2018
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
Why it stopped: withdrawn due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Sherman, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955095
- Sponsor's protocol ID
- 16-01288
- Status last verified
- Oct 2018
- First submitted
- 2 Nov 2016
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Pilot Testing - Intervention for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02955095
- Acronym / sponsor ID
- 16-01288
- Conditions
- Smoking, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn due to lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the usability and pilot testing for the project "Developing a Bi-national Buddy Intervention for Smoking Cessation and Cultural Education" is to better understand how users interact with the smoking cessation app, and to improve the product based on the results. In pilot testing the smoking cessation app the investigators will examine the feasibility of our approach. The usability testing portion of the study is intended primarily to improve on the design of the smoking cessation app, and will: gather quantitative data on participant's performance, identify usability problems, and determine user satisfaction with the app. The pilot testing portion of the study will evaluate the feasibility, time, cost and statistical variability in an attempt to predict an appropriate sample size and improve upon the study design prior to performance of a full-scale research study.
Objective 1:To collect quantitative data on participant's performance while using the app for smoking cessation.
Objective 2:To identify problems with usability of the smoking cessation buddy app.
Objective 3:To assess user satisfaction with the smoking cessation buddy app. Objective 4:To improve upon the design of the smoking cessation buddy app Objective 5:To assess the feasibility, time, cost, and statistical variability for a full-scale implementation of this study with the intervention group.
Detailed description
Tobacco use cessation among youth is not adequately addressed in the US and Russia. The proposed intervention utilizes an innovative evidence-based approach while addressing the shortcomings of prior individual intervention components. In this project, investigators seek to refine a smoking cessation app by conducting two rounds of usability testing followed by a pilot test of the final app, to access usability problems, user satisfaction, and user-friendliness. This data will be collected in a de-identified and confidential manner, and will then be analyzed and used to refine the final app that will later be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Current cigarette smoker | Experimental | Device: Quit Smoking Phone Application |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Current student
- Current cigarette smoker (smoked in past 30 days)
- speak English
- Own a smartphone
- Has some interest in quitting smoking.
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria.
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 |
|---|---|---|
| Quit Smoking Phone ApplicationThe app will be downloaded on participants' phones, and used by the participant for 30 days to make a quit attempt. Participants will be encouraged to use the app every day and to utilize all of its features, including features such as setting a quit date, taking the assessment section, and entering cigarette use and reasons for cravings | Device | Current cigarette smoker |
Primary outcome
Cigarettes smoked per day
Time frame: 30 Days
How many times the app is accessed,
Time frame: 30 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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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.
Scott Sherman, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quit Smoking Phone Application in people with Smoking and Smoking Cessation, run by NYU Langone Health 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 5 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: withdrawn, as of the sponsor's last update on 9 Oct 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cigarettes smoked per day (time frame: 30 Days). 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?
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 9 Oct 2018.