Alcohol and Employment

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by University of Southern Denmark
Sponsor:
Collaborator:
TRYG Foundation
Information provided by (Responsible Party):
Maja Bæksgaard Hansen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01416103
First received: July 12, 2011
Last updated: October 8, 2013
Last verified: December 2011
  Purpose

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.


Condition Intervention
Alcohol Abuse
Other: Intervention group
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Alcohol and Employment - a Randomized Controlled Trial

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • 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.



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. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
Intervention group
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.
Placebo Comparator: Intervention control
Control group
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416103

Contacts
Contact: Maja B. Hansen, Cand.oecon +0045 65507734 mbha@niph.dk
Contact: Janne S. Tolstrup, MD, PhD +0045 65507735 jst@niph.dk

Locations
Denmark
National Institute of Public Health - University of Southern Denmark Recruiting
Copenhagen, Copenhagen K, Denmark, 1353
Contact: Maja B. Hansen, Cand.oecon    +0045 65507734    mbha@niph.dk   
Contact: Janne S. Tolstrup, MD, PhD    +0045 65507735    jst@niph.dk   
Principal Investigator: Maja B. Hansen, Cand.oecon         
Principal Investigator: Janne S. Tolstrup, MD, PhD         
Sponsors and Collaborators
University of Southern Denmark
TRYG Foundation
Investigators
Study Director: Morten Grønbæk, MD, PhD Centre for Intervention Research in Health Promotion and Disease Prevention
  More Information

No publications provided

Responsible Party: Maja Bæksgaard Hansen, Research assistant, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01416103     History of Changes
Other Study ID Numbers: 61110- 1986 (tryg, p7)
Study First Received: July 12, 2011
Last Updated: October 8, 2013
Health Authority: Denmark: TRYG Foundation (Denmark) - Centre for Intervention Research in Health Promotion and Disease Prevention
Denmark: National Institute of Public Health - University of Southern Denmark

ClinicalTrials.gov processed this record on September 30, 2014