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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 12, 2011 | ||||||||
| Last Updated Date | December 15, 2011 | ||||||||
| Start Date ICMJE | October 2011 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change from baseline in the participant's employment status at 6 and 12 months. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ] Change in the participant's employment status, i.e. a) ordinary job, b) change in the participant transfer payments or in other ways approaching the labour market. Employment status is measured with self-reported questionnaires and with a number of administrative registers connected through each participant's personal identification number. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01416103 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Change from baseline in the participant's alcohol consumption, health status and readiness for the labour market at 6 and 12 months. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Alcohol and Employment | ||||||||
| Official Title ICMJE | Alcohol and Employment - a Randomized Controlled Trial | ||||||||
| Brief Summary | The purpose of the study is to determine whether welfare-to-work schemes combined with alcohol treatment are more efficient than a welfare-to-work scheme alone, for unemployed citizens with alcohol problems. |
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| Detailed Description | Background and purpose: The Tryg Foundation Denmark has awarded funds for a study that tests how to most efficiently combine welfare-to-work schemes with efforts against alcoholism, in relation to a return to the labour market. The study will be carried out in a number of Danish municipalities in the time frame 2011-2014. The purpose of the study is to determine whether a welfare-to-work scheme combined with alcohol treatment is more efficient than a welfare-to-work scheme alone, for unemployed citizens with alcohol problems. Design: If the welfare recipient meets the inclusion criteria, then the recipient is provided with information about the project by the caseworker. If the recipient wishes to participate in the project he/she is asked to fill out a consent form and a questionnaire regarding employment status, alcohol consumption, other habits of abuse, health status and background information. Welfare recipients who do not wish to participate will as usual be referred to the welfare-to-work schemes deemed most appropriate by the caseworker. The intervention is designed as a randomized controlled trial, where heavy drinkers who meet the inclusion criteria and wish to participate will be allocated to either: A) An intervention group receiving welfare-to-work scheme combined with alcohol treatment. or B) A control group receiving only welfare-to-work scheme. After 6 and 12 months there will be a follow-up where participants will be asked to answer a questionnaire with questions about their employment status, alcohol consumption, other habits of abuse, health status and background information. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| 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 | Alcohol Abuse | ||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | October 2014 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01416103 | ||||||||
| Other Study ID Numbers ICMJE | 61110- 1986 (tryg, p7) | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Maja Bæksgaard Hansen, University of Southern Denmark | ||||||||
| Study Sponsor ICMJE | University of Southern Denmark | ||||||||
| Collaborators ICMJE | TRYG Foundation | ||||||||
| 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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