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Alcohol and Employment

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ClinicalTrials.gov Identifier: NCT01416103
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
TRYG Foundation
Information provided by (Responsible Party):
Maja Bæksgaard Hansen, University of Southern Denmark

Tracking Information
First Submitted Date  ICMJE July 12, 2011
First Posted Date  ICMJE August 12, 2011
Last Update Posted Date February 19, 2015
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
Change from baseline in the participant's employment status at 6 and 12 months. [ Time Frame: 6 and 12 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
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 ]
  1. Alcohol consumption is measured with The Alcohol Use Disorder Test (AUDIT) and with the average volume of alcohol per week.
  2. Health status is measured with the standardized instrument EQ5D and with questionnaire on self rated health.
  3. Readiness for the labour market is measured with five self rated questionnaires.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.
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.

In this study ANCOVA is chosen to analyses the effective of the intervention.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Alcohol Abuse
Intervention  ICMJE
  • Other: Intervention group
    Alcohol treatment paralleling welfare-to-work participation: The participants are referred to the municipalities' outpatient alcohol treatment programmes and at the same time referred to an ordinary welfare-to-work programme.
  • Other: Control group
    The participants will as usual be referred to the welfare-to-work schemes deemed most appropriate by the caseworker. The intervention is no different than what the municipality would have offered if the participant was not part of the study.
Study Arms  ICMJE
  • Experimental: Intervention group
    Intervention group
    Intervention: Other: Intervention group
  • Placebo Comparator: Intervention control
    Control group
    Intervention: Other: Control group
Publications * Hansen MB, Kloster S, Danquah IH, Nielsen AS, Becker U, Tjørnhøj-Thomsen T, Tolstrup JS. "A welfare recipient may be drinking, but as long as he does as told--he may drink himself to death": a qualitative analysis of project implementation barriers among Danish job consultants. BMC Public Health. 2015 Mar 18;15:264. doi: 10.1186/s12889-015-1620-x.

*   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: February 18, 2015)
113
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2011)
300
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have an audit-score above 7.
  • Participants must be unemployed and receive welfare-to-work schemes when included.

Exclusion Criteria:

  • Participants who have an audit-score below 8.
  • Participants who have a normal job.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01416103
Other Study ID Numbers  ICMJE 61110- 1986 (tryg, p7)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maja Bæksgaard Hansen, University of Southern Denmark
Study Sponsor  ICMJE University of Southern Denmark
Collaborators  ICMJE TRYG Foundation
Investigators  ICMJE
Study Director: Morten Grønbæk, MD, PhD Centre for Intervention Research in Health Promotion and Disease Prevention
PRS Account University of Southern Denmark
Verification Date February 2015

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