'Questions About Quitting' Smoking Cessation Trial (Q2)
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ClinicalTrials.gov Identifier: NCT00992264 |
Recruitment Status
:
Completed
First Posted
: October 9, 2009
Results First Posted
: August 15, 2014
Last Update Posted
: October 13, 2017
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Sponsor:
Kaiser Permanente
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Kaiser Permanente
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Tracking Information | ||||
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First Submitted Date ICMJE | October 7, 2009 | |||
First Posted Date ICMJE | October 9, 2009 | |||
Results First Submitted Date | April 4, 2014 | |||
Results First Posted Date | August 15, 2014 | |||
Last Update Posted Date | October 13, 2017 | |||
Study Start Date ICMJE | May 2010 | |||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00992264 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | 'Questions About Quitting' Smoking Cessation Trial | |||
Official Title ICMJE | Optimizing an Online Motivational Tobacco Cessation Program | |||
Brief Summary | The current study tested the effectiveness of four potentially important tailoring factors (decisional framework, self-efficacy, navigation autonomy, and proactive outreach) in the context of an online motivational intervention for smoking cessation. A fifth factor was originally planned by dropped during intervention development due to confounds with the other planned factors. Information learned from this study will inform how to best design an online interventions for smoking cessation. Participants were recruited from a large, regional U.S. health plan. Using a full factorial design to screen for important main effects and 2-way interactions, participants were randomized to receive one of 16 different experimental factor combinations and followed for one year to assess program impact on smokers' use of empirically-validated cessation treatment and abstinence. | |||
Detailed Description | The current study is a factorial screening experiment, consistent with the Multiphase Optimization Strategy. Participants were randomly assigned to one of 16 different combinations of the 4 experimental factors. Each factor was explored on 2 contrasting levels. Each contrasting factor level was then compared to the other, resulting in 4 analytic arms. Within each arm, all participants (n = 1865) were analyzed to determine the relative effect of each contrasting factor level on the primary and secondary outcomes of interest. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Smoking | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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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 | Completed | |||
Actual Enrollment ICMJE |
1865 | |||
Original Estimated Enrollment ICMJE |
1840 | |||
Actual Study Completion Date | November 2013 | |||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
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 | NCT00992264 | |||
Other Study ID Numbers ICMJE | R01CA138598( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Kaiser Permanente | |||
Study Sponsor ICMJE | Kaiser Permanente | |||
Collaborators ICMJE | University of Michigan | |||
Investigators ICMJE |
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PRS Account | Kaiser Permanente | |||
Verification Date | October 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |