Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT03388320
Status:
UNKNOWN
Last Update Posted:
2019-03-13
First Post:
2017-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2017-12-22', 'studyFirstSubmitQcDate': '2017-12-22', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of recidivism', 'timeFrame': '6 months', 'description': 'Rates of recidivism in this population using A-CHESS will be compared to historical control rates'}], 'secondaryOutcomes': [{'measure': 'Use of A-CHESS', 'timeFrame': '6 months', 'description': 'The association between the extent to which patients use the A-CHESS application and their recidivism; to compare use of the A-CHESS app among subjects who drink and remain abstinent.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases, Alcoholic']}, 'descriptionModule': {'briefSummary': 'This is a pilot study examining whether an evidence-based recovery support smartphone application, the Addiction Comprehensive Health Enhancement Support System (A-CHESS), can decrease alcohol recidivism in a previously unstudied group of patients with alcoholic liver disease (ALD).', 'detailedDescription': "A-CHESS is a smartphone application developed by the University of Wisconsin-Madison based on self-determination theory, with a previous randomized clinical trial showing that use of the app resulted in significantly fewer risky drinking days in patients leaving treatment for alcohol-use disorders. The application is downloaded to the participant's smartphone, and provides ongoing access to peer support and educational materials, monitoring of the risk of relapse, and delivery of reminders and encouragements to the patient. The application also has a survey platform to assess and reassess the participants' most recent alcohol consumption, quality of life, and experience using the application. We anticipate that use of the A-CHESS app will result in decreased drinking and improved abstinence, identifying a potential intervention to offer patients with ALD to improve their mortality, liver disease, and likelihood of liver transplant candidacy status."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alcoholic liver disease\n* Followed or seen at New York Presbyterian Hospital / Weill Cornell Medical Center\n* English speaking\n* Access to a smartphone\n\nExclusion Criteria:\n\n* Unable to consent\n* Primary language other than English\n* No access to a smartphone'}, 'identificationModule': {'nctId': 'NCT03388320', 'briefTitle': 'Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population', 'organization': {'class': 'OTHER', 'fullName': 'New York Presbyterian Hospital'}, 'officialTitle': 'Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population', 'orgStudyIdInfo': {'id': '1704018122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants receiving A-CHESS', 'description': 'Participants will be provided access to the smartphone application A-CHESS (intervention) that will be downloaded to their phone.', 'interventionNames': ['Device: A-CHESS']}], 'interventions': [{'name': 'A-CHESS', 'type': 'DEVICE', 'description': 'Use of smartphone application: Addiction Comprehensive Health Enhancement Support System (A-CHESS)', 'armGroupLabels': ['Participants receiving A-CHESS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole T Shen, MD', 'role': 'CONTACT', 'email': 'nts9004@nyp.org', 'phone': '314-609-5911'}, {'name': 'Cecilia M Mero', 'role': 'CONTACT', 'email': 'cmm2002@med.cornell.edu', 'phone': '(646) 962-9358'}], 'facility': 'New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Nicole T Shen, MD', 'role': 'CONTACT', 'email': 'nts9004@nyp.org', 'phone': '3146095911'}], 'overallOfficials': [{'name': 'Robert S Brown, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Cornell Medical College/NYPH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Presbyterian Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nicole T Shen', 'investigatorAffiliation': 'New York Presbyterian Hospital'}}}}