Usability and Pilot Testing - Intervention for Smoking Ce... | NCT02955095

Studies
Usability and Pilot Testing - Intervention for Smoking Cessation

NCT02955095

Sponsor

NYU Langone Health

Status

Withdrawn

Last Update Posted

Oct 9, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Smoking
Smoking Cessation

Interventions

Quit Smoking Phone Application

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

withdrawn due to lack of funding

Expanded Access Info

Start Date

Aug 2, 2018Actual

Primary Completion Date

Aug 2, 2018Actual

Completion Date

Aug 2, 2018Actual

First Submitted Date

Nov 2, 2016

First Submission Date that Met QC Criteria

Nov 3, 2016

First Posted Date

Nov 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2018

Last Update Posted Date

Oct 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Current cigarette smoker	Experimental		Device: Quit Smoking Phone Application

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quit Smoking Phone Application	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cigarettes smoked per day		30 Days
How many times the app is accessed,		30 Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Current student
Current cigarette smoker (smoked in past 30 days)
speak English
Own a smartphone
Has some interest in quitting smoking.

Exclusion Criteria:

Not meeting inclusion criteria.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

24 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott Sherman, MD	New York University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D012907	Smoking
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D001519	Behavior
D015438	Health Behavior

Browse Leaves

Not provided

Browse Branches

Not provided