Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-31 @ 7:59 AM
Study NCT ID:
NCT01416103
Status:
COMPLETED
Last Update Posted:
2015-02-19
First Post:
2011-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alcohol and Employment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-18', 'studyFirstSubmitDate': '2011-07-12', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in the participant's employment status at 6 and 12 months.", 'timeFrame': '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.\n\nEmployment status is measured with self-reported questionnaires and with a number of administrative registers connected through each participant's personal identification number."}], 'secondaryOutcomes': [{'measure': "Change from baseline in the participant's alcohol consumption, health status and readiness for the labour market at 6 and 12 months.", 'timeFrame': '6 and 12 months', 'description': '1. Alcohol consumption is measured with The Alcohol Use Disorder Test (AUDIT) and with the average volume of alcohol per week.\n2. Health status is measured with the standardized instrument EQ5D and with questionnaire on self rated health.\n3. Readiness for the labour market is measured with five self rated questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Alcohol Abuse']}, 'referencesModule': {'references': [{'pmid': '25886200', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe study will be carried out in a number of Danish municipalities in the time frame 2011-2014.\n\nThe 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.\n\nDesign: 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.\n\nWelfare recipients who do not wish to participate will as usual be referred to the welfare-to-work schemes deemed most appropriate by the caseworker.\n\nThe 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:\n\nA) An intervention group receiving welfare-to-work scheme combined with alcohol treatment.\n\nor\n\nB) A control group receiving only welfare-to-work scheme.\n\nAfter 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.\n\nIn this study ANCOVA is chosen to analyses the effective of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have an audit-score above 7.\n* Participants must be unemployed and receive welfare-to-work schemes when included.\n\nExclusion Criteria:\n\n* Participants who have an audit-score below 8.\n* Participants who have a normal job.'}, 'identificationModule': {'nctId': 'NCT01416103', 'briefTitle': 'Alcohol and Employment', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Alcohol and Employment - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '61110- 1986 (tryg, p7)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intervention group', 'interventionNames': ['Other: Intervention group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intervention control', 'description': 'Control group', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Intervention group', 'type': 'OTHER', '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.", 'armGroupLabels': ['Intervention group']}, {'name': 'Control group', 'type': 'OTHER', '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.', 'armGroupLabels': ['Intervention control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1353', 'city': 'Copenhagen', 'state': 'Copenhagen K', 'country': 'Denmark', 'facility': 'National Institute of Public Health - University of Southern Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Morten Grønbæk, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre for Intervention Research in Health Promotion and Disease Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'TRYG Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Maja Bæksgaard Hansen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}