Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT05244720
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2022-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot study to determine feasibility'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': '6 months', 'description': '\\>50% of those invited to participate gives written consent.'}, {'measure': 'Retention', 'timeFrame': '6 months', 'description': '\\>50% of those recruited and randomized to an examination, will attend for an examination at the hospital'}, {'measure': 'Completion', 'timeFrame': '6 months after randomization', 'description': '\\>50% of randomized patients complete follow-up'}], 'secondaryOutcomes': [{'measure': 'Reduction in Number of heavy drinking days', 'timeFrame': '10 months', 'description': 'Reduction in Number of heavy drinking days, data collected at follow-up after 6 months, compared to baseline data.'}, {'measure': 'Abstinence or reduction in alcohol consumption', 'timeFrame': '10 months', 'description': 'Abstinence from alcohol in the three months prior to the 6-months follow-up phone call.'}, {'measure': 'Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment', 'timeFrame': '6 months', 'description': 'Results from fibroscan, with a mean value of \\>8 indicating fibrosis and a mean value of \\>15 indicating cirrhosis.'}, {'measure': 'Reduction in AUDIT score', 'timeFrame': '10 months', 'description': 'AUDIT score is reported at baseline, and again at the 6 months follow up phone call.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol', 'pilot study', 'feasibility'], 'conditions': ['Liver Diseases']}, 'referencesModule': {'references': [{'pmid': '38755732', 'type': 'DERIVED', 'citation': 'Jepsen P, von Wowern N, Madsen LG, Klausen MK, During S, Benthien KS, Winther-Jensen M, Petersen J, Askgaard G. The LIVER CARE trial - screening for liver disease in individuals attending treatment for alcohol use disorder: a randomized controlled feasibility trial. Pilot Feasibility Stud. 2024 May 16;10(1):78. doi: 10.1186/s40814-024-01504-5.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study aims to evaluate the feasibility of a non-blinded randomized controlled trial with a parallel group design of an invitation to an evaluation of liver disease (intervention) compared to standard care with no invitation, among individuals in alcohol abuse treatment.', 'detailedDescription': 'Alcohol-related liver disease (ALD) is responsible for about 80% of all liver disease in Denmark. The prognosis for ALD is good, if detected early and abstinence is obtained. Unfortunately ALD is often diagnosed at a late state and the 1-year survival is only 30%.\n\nCurrently there is no available systematic screening for fibrosis/cirrhosis among patients with longterm abuse of alcohol and thereby high risk for developing ALD.\n\nTransient elastography (TE) is a non-invasive, risk free and quick method of detecting fibrosis. TE is validated for diagnosing fibrosis and ruling out cirrhosis.\n\n40 patients will be enrolled in the study with a 1:1 randomization. Baseline data is collected and informed concent is obtained at the local alcohol abuse treatment center, Novavi Køge. The fibroscan and blood samples are done at Zealand University Hospital, Køge. Follow-up is done after 6 months, by a project nurse, blinded to the intervention.\n\nIf the study proves to be feasible, our aim is to extend the study in order to investigate wether the interventions described above, could help decrease alcohol consumption/maintain abstinence for patients in alcohol treatment. Moreover the prevalence of fibrosis and cirrhosis found by fibroscan is examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must be enrolled at alcohol treatment center Novavi Koege, Denmark\n* Maximum 6 months of treatment at Novavi Koege\n\nExclusion Criteria:\n\n* known severe liver disease\n* life expectancy less than 6 months\n* unable to give informed written consent'}, 'identificationModule': {'nctId': 'NCT05244720', 'briefTitle': 'Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': 'SJ-934'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Baseline questionnaire filled out at recruitment. Invited to an examination of the liver, by fibroscan and blood samples, shortly after recruitment.\n\nFollow-up by phone after 6 months.', 'interventionNames': ['Diagnostic Test: Fibroscan', 'Diagnostic Test: Blood samples']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Baseline questionnaire filled out at recruitment. Follow-up by phone after 6 months. Invited to an optional examination of the liver, by fibroscan and blood samples, after 6 months.', 'interventionNames': ['Diagnostic Test: Fibroscan', 'Diagnostic Test: Blood samples']}], 'interventions': [{'name': 'Fibroscan', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Transient elastography'], 'description': 'A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Blood samples', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Department of Medicine, Zealand University Hospital', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'overallOfficials': [{'name': 'Gro Askgaard, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Medicine, Zealand University Hospital'}, {'name': 'Lone Madsen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, Zealand University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}