Comparison of Four Different Smoking Cessation Programmes (Fristart)
| Tracking Information | |||||
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| First Received Date ICMJE | November 24, 2011 | ||||
| Last Updated Date | December 19, 2011 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Smoking cessation [ Time Frame: 14 months post baseline ] [ Designated as safety issue: No ] We measure the 30 days point prevalence abstinence rate. We measure whether participants have been totally smokefree for at least 30 days prior to the follow-up date. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01487642 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Four Different Smoking Cessation Programmes | ||||
| Official Title ICMJE | Study of the Effect of Two Different Types of Telephone Counselling Respectively and a Web-based Smoking Cessation Programme Among Adult Daily Cigarette Smokers. | ||||
| Brief Summary | The primary objective of the study is to compare the efficacy of four different smoking cessation programmes, including a proactive telephone counseling intervention, a reactive telephone counseling a and an interactive web-based intervention and (as control) written self-help material. |
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| Detailed Description | Smoking remains the most important threat to public health. The majority of smokers wish to quit smoking and every year a substantial part of smokers makes a quit attempt. However, the majority of smokers tries to quit unassisted and existing smoking cessation interventions are underused. In this study we test the effectiveness of four different smoking cessation interventions in a randomized controlled trial. The study provides knowledge on factors important for recruitment and gives indication on potential reach of interventions among the general population. This knowledge can help us in designing interventions that is both effective but also have a high reach in the general population. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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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 | 1600 | ||||
| Estimated Completion Date | November 2012 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01487642 | ||||
| Other Study ID Numbers ICMJE | NIPH-2066 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Peter Dalum, University of Southern Denmark | ||||
| Study Sponsor ICMJE | University of Southern Denmark | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Southern Denmark | ||||
| Verification Date | December 2011 | ||||
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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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