STORIES-Stories to Communicate Risk About Tobacco
Recruitment status was Active, not recruiting
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | January 10, 2005 | ||||||||||||
| Last Updated Date | February 26, 2009 | ||||||||||||
| Start Date ICMJE | September 2004 | ||||||||||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Smoking cessation [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT00101491 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | STORIES-Stories to Communicate Risk About Tobacco | ||||||||||||
| Official Title ICMJE | Partnership Programs to Reduce Cardiovascular Disparities - Deep South Partnerships for Prevention of CVD Disparities | ||||||||||||
| Brief Summary | The purpose of this study is to develop and test an intervention based on literacy-appropriate electronic tools, tailored to the demographics and readiness for change of the user, to promote tobacco smoking cessation in a low-literacy population. |
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| Detailed Description | PROJECT STORIES: STORIES is one of two intervention trials conducted as part of the "Deep South Partnership for the Prevention of CVD Disparities" under the NHLBI Partnership Programs to Reduce Cardiovascular Disparities. STORIES is an innovative approach to smoking cessation programs provided in medical facilities for patients seeking assistance with quitting smoking. Our approach is to provide the patient with counseling prior to being discharged from the hospital in an effort to assist them with quitting smoking. The DVD will include current and previous smokers telling their stories regarding their tobacco use. We feel having the patient see other people similar to them express their views, struggles and successes with quitting smoking will motivate them to quit smoking. The patient will also receive 3 follow up telephone calls to check on their progress. Our hypothesis is that patients exposed to the interactive DVD will be more likely to quit, compared with those not exposed. The specific aims for this health communication project are: (1) to develop a series of interactive, testimonial-base stage of change-matched Health Communication DVD video interventions targeted at low-income, low-literacy African Americans in the Deep South and a health information interactive DVD for the patients selected in the randomized control group; (2) to train a peer health counselor/research assistant to counsel inpatient smokers to quit and assist the community members with learning to use the DVDs and then to follow-up by telephone at two weeks, three months and six months after discharge following enrollment in the project; and (3) to evaluate the impact of the intervention on processes of change and six month cessation rates among smokers using a group-randomized controlled trial. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Health Communication DVD video
Interactive, testimonial-based, stage of change-matched Health Communication DVD video interventions |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||||||
| Estimated Completion Date | September 2009 | ||||||||||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | African American inpatients receiving treatment in the medicine unit who desire to quit smoking. Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 19 Years to 78 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00101491 | ||||||||||||
| Other Study ID Numbers ICMJE | 1282, U01 HL79153, U01 HL79171 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Catarina Kiefe, MD, PhD, University of Alabama at Birmingham | ||||||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||
| Verification Date | February 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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