Alcohol AbuseNCT01416103
Alcohol and Employment
A study testing Intervention group in people with Alcohol Abuse, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Intervention group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have an audit-score above 7.
- Participants must be unemployed and receive welfare-to-work schemes when included.
Who cannot join
- Participants who have an audit-score below 8.
- Participants who have a normal job.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Institute of Public Health - University of Southern Denmark
Copenhagen, Copenhagen K, 1353
About this study
Official title: Alcohol and Employment - a Randomized Controlled Trial
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.
Read the 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:
- An intervention group receiving welfare-to-work scheme combined with alcohol treatment. or
- 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.
- Conditions
- Alcohol Abuse
- Being tested
- Intervention group, Control group
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
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 groupOther
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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group Receives: Other: Intervention group |
| Intervention control | Placebo comparator | Control group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 and 12 months
Secondary outcomes (1)
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation
- Responsible party
- Principal investigator, Maja Bæksgaard Hansen, University of Southern Denmark
- Investigators
- Morten Grønbæk, MD, PhD, Study director, Centre for Intervention Research in Health Promotion and Disease Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416103
- Sponsor's protocol ID
- 61110- 1986 (tryg, p7)
- Status last verified
- Feb 2015
- First submitted
- 12 Jul 2011
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25886200
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and Employment - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01416103
- Acronym / sponsor ID
- 61110- 1986 (tryg, p7)
- Conditions
- Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- TRYG Foundation
- Study start
- Oct 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- An intervention group receiving welfare-to-work scheme combined with alcohol treatment. or
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention groupIntervention group |
| Intervention control | Placebo comparator | Other: Control groupControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must have an audit-score above 7.
- Participants must be unemployed and receive welfare-to-work schemes when included.
Key exclusion criteria (2 listed)
- Participants who have an audit-score below 8.
- Participants who have a normal job.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupAlcohol 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 | Intervention group |
| Control groupThe 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. | Other | Intervention control |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
- Derived from this study: PubMed 25886200Hansen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Grønbæk, MD, PhD study director
Centre for Intervention Research in Health Promotion and Disease Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Alcohol Abuse, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the participant's employment status at 6 and 12 months. (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01416103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.