- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01967082
APPSPIRE App in Preventing Students From Smoking
APPSPIRE: Expanding the Reach of an Innovative Tobacco Control Program for Youth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Develop a prototype of the APPSPIRE (phone application [app] of a smoking prevention interactive experience).
II. At post assessment, students enrolled in the study will qualitatively provide information about the usability and usefulness for the prevention and cessation sites.
III. Investigate frequency of use of and exposure to APPSPIRE modules via an objective measure of general use.
IV. Investigate how feasible the program will be. V. Obtain a maintained use of APPSPIRE with high completeness and extent of completion.
VI. Evaluate change in stage of change from baseline to about 1 and 4-month follow-ups among participants.
OUTLINE:
Participants attend an audio-taped focus group over 1 hour and are given the APPSPIRE app. After 1 and 4 months of using the app, participants complete a telephone survey over 1 hour to discuss how they liked the app and its usefulness.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
Houston, Texas, United States, 77002
- Houston Community College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Student at Houston Community College (HCC)
- Speak and read English
- Own an iPhone
- Be enrolled in at least one class at HCC
- Provide current contact information
- Smoke 1 or more cigarettes a day (cessation group)
- Have access to the internet (cessation and prevention/advocacy groups)
- Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale
Exclusion Criteria:
- Does not plan to continue as a student at their campus sometime during the year of the study (cessation and prevention/advocacy groups)
- Current tobacco use (prevention/advocacy group)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prevention (focus group, APPSPIRE app, survey)
Participants attend an audio-taped focus group over 1 hour and are given the APPSPIRE app.
After 1 and 4 months of using the app, participants complete a telephone survey over 1 hour to discuss how they liked the app and its usefulness.
|
Complete survey
Given APPSPIRE app
Other Names:
Attend focus group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of APPSPIRE application (app) use
Time Frame: Up to 4 months
|
Will be measured in minutes per day and with descriptive statistics.
Will measure using mean, median and standard deviation for continuous variables.
|
Up to 4 months
|
The Feasibility of the tobacco control program.
Time Frame: Up to 4 months
|
Feasibly will be measured by multiplying the variable of two concepts: ease of use and ability to fit the program into routine schedules.
|
Up to 4 months
|
The Completeness with the Percentages of Participants surveyed.
Time Frame: Up to 4 months
|
Completeness will be measured as the percentage of participants who continue to use AppSPIRE until the 4 month follow up survey.
|
Up to 4 months
|
The extent of completion for the modules AppSPIRE.
Time Frame: Up to 4 months
|
The extent of completion includes the various modules of AppSPIRE.
High extent of completion is obtained if 75% of the participants have completed all modules of AppSPIRE.
|
Up to 4 months
|
The Stages of the Change Scale
Time Frame: Baseline up to 4 months
|
A validated measure, The Stages of Change Scale, will be used to clarify smokers into 3 categories: pre-contemplation, contemplation and preparation.
|
Baseline up to 4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexander V Prokhorov, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2013-0369 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2018-03054 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R41DA035012 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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