Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-02-26 @ 6:50 PM
Study NCT ID:
NCT02374905
Status:
TERMINATED
Last Update Posted:
2019-09-11
First Post:
2015-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing Interventions to Reduce Alcohol Consumption Among Outpatients in a Dental Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D009059', 'term': 'Mouth Diseases'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, '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': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Staff changes and retirement of the primary investigator during the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2015-02-16', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in mean number of alcohol units consumed per week', 'timeFrame': '6-12 months', 'description': 'Number of weekly alcohol units will be recorded before intervention and 3-6 months after intervention'}], 'secondaryOutcomes': [{'measure': 'Improvement of AUDIT-10 (Alcohol Use Disorders Identification Test) Questionnaire Score', 'timeFrame': '6-12 months', 'description': 'AUDIT-10 questionnaire given before and after intervention. A total score is given for the questionnaire based on the answers given. This total score will be compared before and after.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['drinksmeter', 'alcohol counselling'], 'conditions': ['Alcohol Addiction', 'Mouth Diseases']}, 'descriptionModule': {'briefSummary': 'The investigators wish to investigate the feasibility of using a web based drinking app (www.drinksmeter.com) to reduce alcohol consumption among patients attending an outpatient clinic in a dental setting.', 'detailedDescription': 'Any intervention on alcohol use is relevant to patients attending an oral medicine clinic, as alcohol can contribute to/or worsen mouth disorders. For example, research confirms that white and red patches of the lining of the mouth in regular tobacco and alcohol users can change to mouth cancer. Many people do not know that drinking alcohol would increase their mouth cancer risk.\n\nAny new or follow-up patients attending our clinic and reporting drinking over the recommended guidelines (as given by European Code Against Cancer) will be eligible to participate. The study will start on the first visit to the clinic and/or at their follow-up visit. For each volunteer the study will last 3 months. Participants will be allocated to two groups, those receiving routine brief counselling on the day of their visit and those to whom a web-based electronic tool to self-assess is introduced. They will be motivated to use it in the following weeks to reduce consumption . The study will evaluate alcohol consumption levels using tested questionnaires at base-line and exit.\n\nThe investigators will assess the feasibility of the use of an electronic tool in our study population, whether it provided better outcomes compared to standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient attending the Department of Oral Medicine at King's College Hospital and consuming alcohol over recommended guidance (European Code Against Cancer)\n\nExclusion Criteria:\n\n* Patient which cannot understand English\n* Complete lack of IT literacy\n* Patient in contact with a specialized alcohol service"}, 'identificationModule': {'nctId': 'NCT02374905', 'briefTitle': 'Testing Interventions to Reduce Alcohol Consumption Among Outpatients in a Dental Setting', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': "Assess and Improve Patient's Self-reported Alcohol Consumption While Attending the Oral Medicine Clinic", 'orgStudyIdInfo': {'id': 'KCH 14-158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drinksmeter', 'description': 'Web-based application delivering Identification and Brief Advice of Alcohol Use', 'interventionNames': ['Device: Drinksmeter', 'Behavioral: Brief Advice of Alcohol Use']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brief Advice of Alcohol Use', 'description': 'Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician', 'interventionNames': ['Behavioral: Brief Advice of Alcohol Use']}], 'interventions': [{'name': 'Drinksmeter', 'type': 'DEVICE', 'description': 'Web-based application delivering Identification and Brief Advice of Alcohol Use', 'armGroupLabels': ['Drinksmeter']}, {'name': 'Brief Advice of Alcohol Use', 'type': 'BEHAVIORAL', 'description': 'Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician', 'armGroupLabels': ['Brief Advice of Alcohol Use', 'Drinksmeter']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'state': 'Lambeth', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Saman Warnakulasuriya, BDS,PhD,DSc', 'role': 'STUDY_DIRECTOR', 'affiliation': "King's College London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'South London and Maudsley NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and consultant', 'investigatorFullName': 'Saman Warnakulasuriya', 'investigatorAffiliation': "King's College Hospital NHS Trust"}}}}