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Tobacco Pilot Study for Low Income Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017092
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE January 3, 2017
First Posted Date  ICMJE January 11, 2017
Last Update Posted Date December 26, 2019
Actual Study Start Date  ICMJE January 18, 2017
Actual Primary Completion Date January 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
Ease of use of tablet-guided tobacco intervention assessed by interview and summarized across study participants [ Time Frame: Immediately after exposure to intervention ]
At the end of the intervention, each study participant will be interviewed regarding how easy the tablet computer was to use. This qualitative information will by summarized across all study participants.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tobacco Pilot Study for Low Income Smokers
Official Title  ICMJE Tobacco Pilot Study for Low Income Smokers
Brief Summary Pilot study to test feasibility of delivering a motivational smoking cessation intervention to low income smokers via a computer tablet.
Detailed Description Twenty Salvation Army clients will be recruited to pilot test a motivational smoking cessation counseling intervention that is delivered via a tablet computer. Study participants will be given brief instructions on how to use the tablet. They will then complete a brief survey on the tablet. This will be followed by the researcher using the tablet to provide the motivational intervention. Finally, study participants will be interviewed to establish this perceptions of the intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE Behavioral: Tablet-guided tobacco intervention
This intervention, as guided by a tablet computer, is a brief (20 minute) counseling intervention designed to increase motivation to quit smoking and to increase knowledge of methods of quitting.
Study Arms  ICMJE Experimental: tablet-guided
Study participants will be administered a brief tobacco intervention by a Salvation Army staff person who is guided by a tablet computer
Intervention: Behavioral: Tablet-guided tobacco intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 27, 2017
Actual Primary Completion Date January 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • current smoker (≥ 10 cigarettes/week for the past six months who are not currently trying to quit)
  • age ≥ 18 years
  • English speaking/writing

Exclusion Criteria:

  • not receiving services for the Salvation Army
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03017092
Other Study ID Numbers  ICMJE 2016-1442
1R35CA197573-01 ( U.S. NIH Grant/Contract )
A534252 ( Other Identifier: UW Madison )
SMPH\MEDICINE\TOBACCO RE ( Other Identifier: UW Madison )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE Not Provided
PRS Account University of Wisconsin, Madison
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP