Alcohol and Employment

Alcohol Abuse Clinical Trial

Official title:

Alcohol and Employment - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416103
• Other study ID #: 61110- 1986 (tryg, p7)
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: February 18, 2015
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: TRYG Foundation (Denmark) - Centre for Intervention Research in Health Promotion and Disease PreventionDenmark: National Institute of Public Health - University of Southern Denmark
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Abuse

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	National Institute of Public Health - University of Southern Denmark	Copenhagen	Copenhagen K

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 and 12 months	No
Secondary	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.	6 and 12 months	No