Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-03 @ 8:56 PM
Study NCT ID:
NCT03195894
Status:
COMPLETED
Last Update Posted:
2021-12-13
First Post:
2017-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], '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': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'markku.hamalainen@kontigocare.com', 'phone': '0769 47 31 32', 'title': 'Markku Hämäläinen, Research Director', 'organization': 'KontigoCare AB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to unrealistic assumptions in the sample size calculations, difficulties in recruiting subjects and high dropout rate, the study was inconclusive.\n\nThe poor recruitment rate and poor retention of patients in the study was a challenge (in addition with the quality of self-reported outcomes). The drop-out rate, especially between month 6-12, was a problem both in treatment and control groups.'}}, 'adverseEventsModule': {'timeFrame': 'Safety with collection of adverse events was followed for each patient from Baseline (start of study) until the 12-month visit (end of study).', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 5, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 4, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Cold, fever, flu', 'notes': 'Five patients reported cold, or flu-like symptoms and fever.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Four patients reported pain in foot, hand, or thumb.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Ascites', 'notes': 'Ascites due to liver cirrhosis. Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'notes': 'Bleeding esophagusvarices and duodenal ulcus. Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'notes': 'Staphylococcus aureus sepsis. Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abstinence', 'notes': 'Hospitalization due to alcohol abstinence. Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fainting, dizziness and nausea', 'notes': 'Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suspected transient ischemic attack (TIA)', 'notes': 'Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection in foot', 'notes': 'Infection in foot after surgery. Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'notes': 'Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol intoxication', 'notes': 'Intoxication, lowered consciousness and delirium. Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide attempts', 'notes': 'Not related to device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Recurrent ischemic pain', 'notes': 'Not related to device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With no Heavy Drinking Days After 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver\n\nTripleA'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment only.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Four weeks period before the 12 months visit', 'description': 'Difference between the treatment arms in percentage of patients with no heavy drinking days during the 4-weeks period before the 12 months follow-up visit .', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the planned patient number (216 patients) only approximately 25% or less was analyzed due to poor recruitment rate and a high drop-out of patients during the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Sober Patients During the Period Before the 6 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The four weeks-period before the 6 months visit', 'description': 'Difference in percentage of sober patients (zero drinks during one month reporting period) during the four weeks period before the 6 months visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Sober Patients Before the 12 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The four weeks-period before the 12 months visit', 'description': 'Percentage of sober patients (zero drinks during one month reporting period) during the four weeks period before the 12 months visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '183.7', 'spread': '147.27', 'groupId': 'OG000'}, {'value': '180.62', 'spread': '187.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The four weeks-period before the baseline visit and before the 6 months visit', 'description': 'Number of drinks during the 4 weeks period before the baseline visit minus number of drinks during the 4 weeks period before the 6 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.', 'unitOfMeasure': 'Number of drinks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '195.02', 'spread': '170.29', 'groupId': 'OG000'}, {'value': '150.93', 'spread': '164.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The four weeks-period before the baseline visit and before the 12 months visit', 'description': 'Number of drinks during the 4 weeks period before the baseline visit minus number of drinks during the 4 weeks period before the 12 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.', 'unitOfMeasure': 'Number of drinks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.21', 'spread': '10.79', 'groupId': 'OG000'}, {'value': '14.41', 'spread': '10.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The four weeks-period before the baseline visit and before the 6 months visit', 'description': 'Number of heavy drinking days during the 4 weeks period before the baseline visit minus number of heavy drinking days during the 4 weeks period before the 6 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.', 'unitOfMeasure': 'Number of heavy drinking days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.65', 'spread': '10.61', 'groupId': 'OG000'}, {'value': '13.54', 'spread': '10.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The four weeks-period before the baseline visit and before the 12 months visit', 'description': 'Number of heavy drinking days during the 4 weeks period before the baseline visit minus number of heavy drinking days during the 4 weeks period before the 12 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.', 'unitOfMeasure': 'Number of heavy drinking days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.87', 'spread': '10.11', 'groupId': 'OG000'}, {'value': '-15.35', 'spread': '10.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The four weeks-period before the baseline visit and before the 6 months visit', 'description': 'Number of sober days during the 4 weeks period before the baseline visit minus number of sober days during the 4 weeks period before the 6 months visit. A negative difference means a reduction in drinking. A positive difference means increased drinking.', 'unitOfMeasure': 'Difference in number of sober days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.38', 'spread': '9.80', 'groupId': 'OG000'}, {'value': '-13.04', 'spread': '11.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The four weeks-period before the baseline visit and before the 12 months visit', 'description': 'Number of sober days during the 4 weeks period before the baseline visit minus number of sober days during the 4 weeks period before the 12 months visit. A negative difference means a reduction in drinking. A positive difference means increased drinking.', 'unitOfMeasure': 'Difference in number of sober days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.70', 'spread': '5.73', 'groupId': 'OG000'}, {'value': '7.36', 'spread': '7.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The four weeks-period before the baseline visit and before the 6 months visit', 'description': 'Number of standard glasses/drinks per drinking day during the 4 weeks period before the baseline visit minus number of standard glasses/drinks per drinking day during the 4 weeks period before the 6 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.', 'unitOfMeasure': 'Average no of glasses per drinking day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.52', 'spread': '6.61', 'groupId': 'OG000'}, {'value': '7.03', 'spread': '6.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The four weeks-period before the baseline visit and before the 12 months visit', 'description': 'Number of standard glasses/drinks per drinking day during the 4 weeks period before the baseline visit minus number of standard glasses/drinks per drinking day during the 4 weeks period before the 12 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.', 'unitOfMeasure': 'Average no of glasses per drinking day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Heavy Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '187.3', 'spread': '139.3', 'groupId': 'OG000'}, {'value': '141.2', 'spread': '134.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of randomization until the date of first heavy drinking day, assessed up to 12 months', 'description': 'Time period in days from randomization to first heavy drinking day. Longer time means a better result.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Health Outcome, Measured With the Visual Analog Scale (EQ VAS) in EQ-5D at the Baseline Visit Compared to the 6 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.84', 'spread': '21.52', 'groupId': 'OG000'}, {'value': '6.27', 'spread': '22.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, After 6 months', 'description': 'Change in health outcome, measured with the visual analog scale (EQ VAS) in EQ-5D after 6 months compared to baseline. The EQ-5D is a standardized instrument for measuring and describing health outcomes. VAS score is 0-100 where 0 is the worst possible health and 100 is the best possible health. A positive difference indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Health Outcome, Measured With the Visual Analog Scale (EQ VAS) in EQ-5D From the Baseline Visit Compared to the 12 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.23', 'spread': '22.07', 'groupId': 'OG000'}, {'value': '8.18', 'spread': '20.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, After 12 months', 'description': 'Change in health outcome, measured with the visual analog scale (EQ VAS) in EQ-5D after12 months compared to baseline. The EQ-5D is a standardized instrument for measuring and describing health outcomes. VAS score is 0-100 where 0 is the worst possible health and 100 is the best possible health. A positive number indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '1.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, After 6 months', 'description': 'Change in health outcome, measured with the questionnaire in EQ-5D after 6 months compared to baseline. The questionnaire EQ-5D in EQ-5D consists of 5 questions giving score 5 - 15. A higher positive number indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, After 12 months', 'description': 'Change in health outcome, measured with the questionnaire in EQ-5D after 12 months minus baseline. The questionnaire EQ-5D in EQ-5D consists of 5 questions giving score 5 - 15. A higher positive number indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 12 months', 'description': 'Percentage of patients who have reduced their AUDIT score (Alcohol Use Disorders Identification Test, score 0-40) after 12 months. Higher proportion is better.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 12 months', 'description': 'Percentage of patients who have reduced their Alcohol Use Disorders Identification Test (AUDIT) risk zones with at least one zone. Higher proportion is better.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Having a Risk Level <II (i.e. Less Than 6 AUDIT Points for Women, 8 AUDIT Points for Men) After 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 12 months', 'description': 'Percentage of patients having a risk level \\<II (i.e. less than Alcohol Use Disorders Identification Test (AUDIT) points, i.e. 6 points for women, 8 points for men) after 12 months. Higher proportion is better.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.39', 'spread': '9.53', 'groupId': 'OG000'}, {'value': '11.76', 'spread': '9.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, After 6 months', 'description': 'Change in degree of alcohol dependence measured as the difference in Short Alcohol Dependence Data (SADD)-points at baseline minus 6 months Scoring: The 15 items summed for a total score than can range from 0 to 45. Scale totals are interpreted as follows: 1-9 low dependence, 10-19 medium dependence, and 20 or greater high dependence. A large positive number indicates a better result.', 'unitOfMeasure': 'Difference in SADD-points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.00', 'spread': '10.56', 'groupId': 'OG000'}, {'value': '11.19', 'spread': '9.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, After 12 months', 'description': 'Change in degree of alcohol dependence measured as the difference in Short Alcohol Dependence Data (SADD)-points at baseline minus 12 months. Scoring: The 15 items summed for a total score than can range from 0 to 45. Scale totals are interpreted as follows: 1-9 low dependence, 10-19 medium dependence, and 20 or greater high dependence. A large positive number indicates a better result.', 'unitOfMeasure': 'Difference in SADD-points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compliance With Agreed Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, After 12 months', 'description': 'Percentage of subjects staying in the study to the 12 months visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, After 6 months', 'description': 'Change in concentration of the alcohol metabolite PEth at baseline minus 6 months. A larger positive change of PEth concentration is a better outcome.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, After 12 months', 'description': 'Change in concentration of the alcohol metabolite PEth at baseline minus 12 months. A larger positive change of PEth concentration is a better outcome.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, After 6 months', 'description': 'CDT (Carbohydrate Deficient Transferrin) concentration is given in % of total transferrin in serum, i e. CDT(%). The change is calculated as baseline CDT (%) minus CDT(%) at 6 months. A large positive difference indicates decreased drinking.', 'unitOfMeasure': 'percentage CDT of total transferrin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'OG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment consisting of medication treatment or the Minnesota model of addiction treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, After 12 months', 'description': 'CDT (Carbohydrate Deficient Transferrin) concentration is given in % of total transferrin in serum, i e. CDT(%). The change is calculated as baseline CDT (%) minus CDT(%) at 12 months. A large positive difference indicates decreased drinking.', 'unitOfMeasure': 'percentage CDT of total transferrin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver'}, {'id': 'FG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment may be medication or 12-step addiction treatment according to the Minnesota model.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'An example is "Started other treatment".', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'Patients were recruited at two sites (Uppsala University Hospital and Nämndemansgården) beginning in October 2015 . Recruitment continued until January 2017 and the last follow-up visits were conducted in December 2017 (Uppsala University Hospital) and in January 2018 (Nämndemansgården), respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver TripleA.'}, {'id': 'BG001', 'title': 'Conventional Treatment', 'description': 'Conventional treatment which is medication or a 12-step addiction treatment according to the Minnesota model.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.1', 'spread': '8.16', 'groupId': 'BG000'}, {'value': '53.8', 'spread': '9.63', 'groupId': 'BG001'}, {'value': '53.4', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patients (n=115) were recruited to clinical trials from a 12-step aftercare programme(12S-ABS) and from hospital care with abstinence (HC-ABS) or controlled drinking (HC-CDR) as goal. The subject population for study KC102-001 was formed by 71 subjects enrolled at Uppsala University Hospital. Study KC102-002 included 44 subjects registered at Nämndemansgårdens treatment home.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-26', 'size': 2443350, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-25T09:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, controlled, open study to compare conventional treatment with and without addition of TripleA'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2017-05-11', 'resultsFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-09', 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With no Heavy Drinking Days After 12 Months', 'timeFrame': 'Four weeks period before the 12 months visit', 'description': 'Difference between the treatment arms in percentage of patients with no heavy drinking days during the 4-weeks period before the 12 months follow-up visit .'}], 'secondaryOutcomes': [{'measure': 'Percentage of Sober Patients During the Period Before the 6 Months Visit', 'timeFrame': 'The four weeks-period before the 6 months visit', 'description': 'Difference in percentage of sober patients (zero drinks during one month reporting period) during the four weeks period before the 6 months visit.'}, {'measure': 'Percentage of Sober Patients Before the 12 Months Visit', 'timeFrame': 'The four weeks-period before the 12 months visit', 'description': 'Percentage of sober patients (zero drinks during one month reporting period) during the four weeks period before the 12 months visit.'}, {'measure': 'Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit', 'timeFrame': 'The four weeks-period before the baseline visit and before the 6 months visit', 'description': 'Number of drinks during the 4 weeks period before the baseline visit minus number of drinks during the 4 weeks period before the 6 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.'}, {'measure': 'Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit', 'timeFrame': 'The four weeks-period before the baseline visit and before the 12 months visit', 'description': 'Number of drinks during the 4 weeks period before the baseline visit minus number of drinks during the 4 weeks period before the 12 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.'}, {'measure': 'Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit', 'timeFrame': 'The four weeks-period before the baseline visit and before the 6 months visit', 'description': 'Number of heavy drinking days during the 4 weeks period before the baseline visit minus number of heavy drinking days during the 4 weeks period before the 6 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.'}, {'measure': 'Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit', 'timeFrame': 'The four weeks-period before the baseline visit and before the 12 months visit', 'description': 'Number of heavy drinking days during the 4 weeks period before the baseline visit minus number of heavy drinking days during the 4 weeks period before the 12 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.'}, {'measure': 'Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit', 'timeFrame': 'The four weeks-period before the baseline visit and before the 6 months visit', 'description': 'Number of sober days during the 4 weeks period before the baseline visit minus number of sober days during the 4 weeks period before the 6 months visit. A negative difference means a reduction in drinking. A positive difference means increased drinking.'}, {'measure': 'Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit', 'timeFrame': 'The four weeks-period before the baseline visit and before the 12 months visit', 'description': 'Number of sober days during the 4 weeks period before the baseline visit minus number of sober days during the 4 weeks period before the 12 months visit. A negative difference means a reduction in drinking. A positive difference means increased drinking.'}, {'measure': 'Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit', 'timeFrame': 'The four weeks-period before the baseline visit and before the 6 months visit', 'description': 'Number of standard glasses/drinks per drinking day during the 4 weeks period before the baseline visit minus number of standard glasses/drinks per drinking day during the 4 weeks period before the 6 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.'}, {'measure': 'Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit', 'timeFrame': 'The four weeks-period before the baseline visit and before the 12 months visit', 'description': 'Number of standard glasses/drinks per drinking day during the 4 weeks period before the baseline visit minus number of standard glasses/drinks per drinking day during the 4 weeks period before the 12 months visit. A positive difference means a reduction in drinking. A negative difference means increased drinking.'}, {'measure': 'Time to Heavy Drinking', 'timeFrame': 'From date of randomization until the date of first heavy drinking day, assessed up to 12 months', 'description': 'Time period in days from randomization to first heavy drinking day. Longer time means a better result.'}, {'measure': 'Change in Health Outcome, Measured With the Visual Analog Scale (EQ VAS) in EQ-5D at the Baseline Visit Compared to the 6 Months Visit', 'timeFrame': 'Baseline, After 6 months', 'description': 'Change in health outcome, measured with the visual analog scale (EQ VAS) in EQ-5D after 6 months compared to baseline. The EQ-5D is a standardized instrument for measuring and describing health outcomes. VAS score is 0-100 where 0 is the worst possible health and 100 is the best possible health. A positive difference indicates improvement.'}, {'measure': 'Change in Health Outcome, Measured With the Visual Analog Scale (EQ VAS) in EQ-5D From the Baseline Visit Compared to the 12 Months Visit', 'timeFrame': 'Baseline, After 12 months', 'description': 'Change in health outcome, measured with the visual analog scale (EQ VAS) in EQ-5D after12 months compared to baseline. The EQ-5D is a standardized instrument for measuring and describing health outcomes. VAS score is 0-100 where 0 is the worst possible health and 100 is the best possible health. A positive number indicates improvement.'}, {'measure': 'Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline', 'timeFrame': 'Baseline, After 6 months', 'description': 'Change in health outcome, measured with the questionnaire in EQ-5D after 6 months compared to baseline. The questionnaire EQ-5D in EQ-5D consists of 5 questions giving score 5 - 15. A higher positive number indicates improvement.'}, {'measure': 'Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline', 'timeFrame': 'Baseline, After 12 months', 'description': 'Change in health outcome, measured with the questionnaire in EQ-5D after 12 months minus baseline. The questionnaire EQ-5D in EQ-5D consists of 5 questions giving score 5 - 15. A higher positive number indicates improvement.'}, {'measure': 'Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months', 'timeFrame': 'After 12 months', 'description': 'Percentage of patients who have reduced their AUDIT score (Alcohol Use Disorders Identification Test, score 0-40) after 12 months. Higher proportion is better.'}, {'measure': 'Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months', 'timeFrame': 'After 12 months', 'description': 'Percentage of patients who have reduced their Alcohol Use Disorders Identification Test (AUDIT) risk zones with at least one zone. Higher proportion is better.'}, {'measure': 'Percentage of Patients Having a Risk Level <II (i.e. Less Than 6 AUDIT Points for Women, 8 AUDIT Points for Men) After 12 Months', 'timeFrame': 'After 12 months', 'description': 'Percentage of patients having a risk level \\<II (i.e. less than Alcohol Use Disorders Identification Test (AUDIT) points, i.e. 6 points for women, 8 points for men) after 12 months. Higher proportion is better.'}, {'measure': 'Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months', 'timeFrame': 'Baseline, After 6 months', 'description': 'Change in degree of alcohol dependence measured as the difference in Short Alcohol Dependence Data (SADD)-points at baseline minus 6 months Scoring: The 15 items summed for a total score than can range from 0 to 45. Scale totals are interpreted as follows: 1-9 low dependence, 10-19 medium dependence, and 20 or greater high dependence. A large positive number indicates a better result.'}, {'measure': 'Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months', 'timeFrame': 'Baseline, After 12 months', 'description': 'Change in degree of alcohol dependence measured as the difference in Short Alcohol Dependence Data (SADD)-points at baseline minus 12 months. Scoring: The 15 items summed for a total score than can range from 0 to 45. Scale totals are interpreted as follows: 1-9 low dependence, 10-19 medium dependence, and 20 or greater high dependence. A large positive number indicates a better result.'}, {'measure': 'Compliance With Agreed Treatment', 'timeFrame': 'Baseline, After 12 months', 'description': 'Percentage of subjects staying in the study to the 12 months visit.'}, {'measure': 'Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit', 'timeFrame': 'Baseline, After 6 months', 'description': 'Change in concentration of the alcohol metabolite PEth at baseline minus 6 months. A larger positive change of PEth concentration is a better outcome.'}, {'measure': 'Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months', 'timeFrame': 'Baseline, After 12 months', 'description': 'Change in concentration of the alcohol metabolite PEth at baseline minus 12 months. A larger positive change of PEth concentration is a better outcome.'}, {'measure': 'Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months', 'timeFrame': 'Baseline, After 6 months', 'description': 'CDT (Carbohydrate Deficient Transferrin) concentration is given in % of total transferrin in serum, i e. CDT(%). The change is calculated as baseline CDT (%) minus CDT(%) at 6 months. A large positive difference indicates decreased drinking.'}, {'measure': 'Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months', 'timeFrame': 'Baseline, After 12 months', 'description': 'CDT (Carbohydrate Deficient Transferrin) concentration is given in % of total transferrin in serum, i e. CDT(%). The change is calculated as baseline CDT (%) minus CDT(%) at 12 months. A large positive difference indicates decreased drinking.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcohol abuse, Alcoholometer, Medical Device, App'], 'conditions': ['Alcoholism']}, 'referencesModule': {'references': [{'pmid': '29590325', 'type': 'DERIVED', 'citation': 'Hamalainen MD, Zetterstrom A, Winkvist M, Soderquist M, Karlberg E, Ohagen P, Andersson K, Nyberg F. Real-time Monitoring using a breathalyzer-based eHealth system can identify lapse/relapse patterns in alcohol use disorder Patients. Alcohol Alcohol. 2018 Jul 1;53(4):368-375. doi: 10.1093/alcalc/agy011.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to investigate differences in the alcohol consumption pattern between alcohol addicts receiving conventional treatment and those who receive a combination of conventional treatment and TripleA.', 'detailedDescription': 'The study is a 12-month open-label and randomised comparison between the control group receiving only conventional treatment and the intervention group receiving conventional treatment enhanced with TripleA.\n\nThe studies have been designed to reflect as far as possible the conventional care for alcohol dependence. The TripleA product is intended to strengthen the existing methods used during the assessment phase, treatment phase and aftercare of alcohol dependence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in care at Addiction and Neuropsychiatry Uppsala University Hospital and at Nämndemansgården Uppsala\n* 18 years or older\n* Meets at least 2 of the criteria for addiction/substance syndrome according to Diagnostic and statistical manual of mental disorders-5 (DSM-5)\n* Ability to understand and communicate in Swedish\n* Ability to handle the technical equipment used in the study (alcoholometer and Smartphone)\n* Access to a fixed place (living, place for sleeping, place where the phone can be charged\n\nExclusion Criteria:\n\n* Schizophrenia\n* Substance syndrome related to other substances than alcohol and nicotin\n* Lowered lung function (not able to reach acceptable expiration volume for the alcoholometer function)\n* The patient is taken care of within the frame for The Act on Care of Addicts\n* Not suitable to participate according to the Investigator\n* Has not consumed any alcohol during the 4 weeks defined as baseline timeline follow back\n* Normalized Carbohydrate Deficient Transferrin (CDT) and Phosphatidyl-Ethanol (PEth)-values in blood samples at visit 1'}, 'identificationModule': {'nctId': 'NCT03195894', 'briefTitle': 'Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kontigo Care AB'}, 'officialTitle': 'Clinical Study of TripleA Connected to Diagnosis, Care and Aftercare of Alcohol Addiction in Outpatient Care', 'orgStudyIdInfo': {'id': 'KC102-001/KC102-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional treatment and TripleA', 'description': 'Conventional treatment and TripleA medical device consisting of alcoholometer, a Bluetooth mobile app on cell phone and information stored on computer for caregiver', 'interventionNames': ['Device: TripleA']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional treatment', 'description': 'Conventional treatment'}], 'interventions': [{'name': 'TripleA', 'type': 'DEVICE', 'armGroupLabels': ['Conventional treatment and TripleA']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tobias Eriksson, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kontigo Care AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}