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Alcohol and Employment

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intervention group
Control group
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Public Health - University of Southern Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Intervention control

Arm Description

Intervention group

Control group

Outcomes

Primary Outcome Measures

Change from baseline in the participant's employment status at 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.

Secondary Outcome Measures

Change from baseline in the participant's alcohol consumption, health status and readiness for the labour market at 6 and 12 months.
Alcohol consumption is measured with The Alcohol Use Disorder Test (AUDIT) and with the average volume of alcohol per week. Health status is measured with the standardized instrument EQ5D and with questionnaire on self rated health. Readiness for the labour market is measured with five self rated questionnaires.

Full Information

First Posted
July 12, 2011
Last Updated
February 18, 2015
Sponsor
University of Southern Denmark
Collaborators
TRYG Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01416103
Brief Title
Alcohol and Employment
Official Title
Alcohol and Employment - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
TRYG Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention group
Arm Title
Intervention control
Arm Type
Placebo Comparator
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Intervention group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in the participant's employment status at 6 and 12 months.
Description
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.
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Change from baseline in the participant's alcohol consumption, health status and readiness for the labour market at 6 and 12 months.
Description
Alcohol consumption is measured with The Alcohol Use Disorder Test (AUDIT) and with the average volume of alcohol per week. Health status is measured with the standardized instrument EQ5D and with questionnaire on self rated health. Readiness for the labour market is measured with five self rated questionnaires.
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Grønbæk, MD, PhD
Organizational Affiliation
Centre for Intervention Research in Health Promotion and Disease Prevention
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Public Health - University of Southern Denmark
City
Copenhagen
State/Province
Copenhagen K
ZIP/Postal Code
1353
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25886200
Citation
Hansen MB, Kloster S, Danquah IH, Nielsen AS, Becker U, Tjornhoj-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.
Results Reference
derived

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Alcohol and Employment

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