Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02642757
Status:
COMPLETED
Last Update Posted:
2019-05-22
First Post:
2015-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alcohol Brief Counseling in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-15'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-20', 'studyFirstSubmitDate': '2015-12-28', 'studyFirstSubmitQcDate': '2015-12-29', 'lastUpdatePostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUDIT score', 'timeFrame': '6 months post brief intervention', 'description': 'Total of questions 1 to 10 (minimum 0, maximum 40)'}], 'secondaryOutcomes': [{'measure': 'AUDIT-C score', 'timeFrame': '6 months post brief intervention', 'description': 'Total of questions 1 to 3 (minimum 0, maximum 12)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['alcohol drinking', 'hazardous alcohol use', 'risky alcohol consumption', 'heavy alcohol consumption'], 'conditions': ['Alcohol Drinking']}, 'referencesModule': {'references': [{'pmid': '34130748', 'type': 'DERIVED', 'citation': 'Barticevic NA, Poblete F, Zuzulich SM, Rodriguez V, Quevedo D, Sena BF, Bradshaw L. A Health Technician-delivered Brief Intervention linked to AUDIT for reduction of alcohol use in Chilean primary care: a randomized controlled trial. Addict Sci Clin Pract. 2021 Jun 15;16(1):39. doi: 10.1186/s13722-021-00248-4.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of a brief intervention for the reduction of alcohol use among risky alcohol users in primary care delivered by paramedics. Half of the participants will receive a brief intervention and half will receive written guidelines on safe alcohol use.', 'detailedDescription': 'Randomized controlled trial with a pragmatic emphasis undertaken in real world primary care.\n\nThe brief intervention has been designed and piloted by the mental health team at the Chilean ministry of health, as also the written support material. This intervention is the same that is being implemented national wide.\n\nThe implementation will include training of the paramedics, and then an accreditation session with a simulated participant in a double sided mirror.\n\nRandomization will take place on site using a opaque envelope. The sequence will be keep on site in a secured box.\n\nData will be registered by the same person delivering the intervention and kept safe at the clinical sites. Once a month the data will be physically transferred to the operational center at the San Joaquin site of the Catholic University of Chile.\n\nBimonthly visits will be performed to the centers by a member of the team to assure that the protocol is being followed and data audit.\n\nThe participants will receive an economical incentive for the follow up visit. Participants will be reached throw telephone at least twice to schedule that visit. If not possible, a telephonic outcome assessment or a domiciliary visit will be performed to minimize the lost in follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* AUDIT score between 8 and 15\n* Able to read\n* Haven't received a similar intervention in the last 3 months\n\nExclusion Criteria:\n\n* Clients in treatment for alcohol use disorder\n* Alcohol use treatment seekers\n* Pregnant woman\n* Severe physical or psychiatric pathology not stable"}, 'identificationModule': {'nctId': 'NCT02642757', 'briefTitle': 'Alcohol Brief Counseling in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Effectiveness of a Brief Intervention for Reducing the Alcohol Use in Risky Users Delivered by Paramedics in Primary Care', 'orgStudyIdInfo': {'id': '14-214'}, 'secondaryIdInfos': [{'id': 'SM14I0033', 'type': 'OTHER_GRANT', 'domain': 'FONIS Chile'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief intervention', 'description': 'AUDIT brief intervention', 'interventionNames': ['Behavioral: AUDIT brief intervention', 'Other: Pamphlet on alcohol use']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Pamphlet on alcohol use', 'interventionNames': ['Other: Pamphlet on alcohol use']}], 'interventions': [{'name': 'AUDIT brief intervention', 'type': 'BEHAVIORAL', 'description': 'Intervention will be provided following the Chilean ministry of health implementation manual on the AUDIT associated brief intervention. The pamphlet on alcohol use will be provided to participants.', 'armGroupLabels': ['Brief intervention']}, {'name': 'Pamphlet on alcohol use', 'type': 'OTHER', 'description': 'Only the pamphlet on alcohol use will be provided (the same received by participants on the intervention group). This is not an active intervention based on the current literature.', 'armGroupLabels': ['Brief intervention', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8181297', 'city': 'Santiago', 'state': 'Puente Alto', 'country': 'Chile', 'facility': 'CESFAM San Alberto Hurtado', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'state': 'Puente Alto', 'country': 'Chile', 'facility': 'CESFAM Madre Teresa de Calcuta', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'state': 'San Miguel', 'country': 'Chile', 'facility': 'CESFAM Barros Luco', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'state': 'San Miguel', 'country': 'Chile', 'facility': 'CESFAM Recreo', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'CESFAM Juan Pablo II', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Nicolas Barticevic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instructor Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}