Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT05783635
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2023-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alcohol Screening and Preoperative Intervention Research Study - 2
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': 'D011184', 'term': 'Postoperative Period'}], 'ancestors': [{'id': 'D059035', 'term': 'Perioperative Period'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The proposed study will achieve this using a Sequential Multiple Assignment Randomized Trial (SMART) design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol consumption as measured by the timeline follow-back', 'timeFrame': '10 months after surgical discharge', 'description': 'Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including average drinks/day.'}], 'secondaryOutcomes': [{'measure': 'World Health Organization Drinking (WHO) Risk Level', 'timeFrame': '10 months after surgical discharge', 'description': 'WHO drinking risk levels derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).'}, {'measure': 'Alcohol Use Disorder Identification test (AUDIT)', 'timeFrame': 'Up to 10 months after surgical discharge', 'description': "We will calculate participant's total score on the AUDIT measure. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use and presence of more alcohol use disorder symptoms."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgery'], 'conditions': ['Alcohol Drinking']}, 'descriptionModule': {'briefSummary': 'This sequential, multiple assignment, randomized trial will test treatments designed to reduce alcohol use before and after surgery to promote surgical health and long-term wellness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Completed consent form, baseline survey, and enrollment phone call\n2. Willingness to comply with all study procedures and availability for the duration of the study\n3. Scheduled for select major elective surgery (non-cancer) in the next 5-12 weeks\n4. Score ≥ 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications\n5. Access to a smart device or computer access with internet or wi-fi connection throughout the study period\n\nExclusion Criteria:\n\n1. Exclude participants enrolled in another research study focused on alcohol use\n2. History of severe alcohol withdrawal\n3. Unable to speak, understand, or read English'}, 'identificationModule': {'nctId': 'NCT05783635', 'acronym': 'ASPIRE-2', 'briefTitle': 'Alcohol Screening and Preoperative Intervention Research Study - 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Reducing Alcohol Use Among Elective Surgical Patients Using Adaptive Interventions', 'orgStudyIdInfo': {'id': 'HUM00208317'}, 'secondaryIdInfos': [{'id': 'R01AA029666', 'link': 'https://reporter.nih.gov/quickSearch/R01AA029666', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Usual Care then Usual Surgical Care', 'description': 'Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care', 'interventionNames': ['Behavioral: Enhanced Usual Care (pre-operative)', 'Behavioral: Usual surgical care (post-operative)']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Usual Care then Post-operative Health Coaching', 'description': 'Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care', 'interventionNames': ['Behavioral: Enhanced Usual Care (pre-operative)', 'Behavioral: Postoperative Virtual Health Coaching']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Usual Care then On-Track', 'description': 'Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care', 'interventionNames': ['Behavioral: Enhanced Usual Care (pre-operative)', 'Behavioral: On-Track (Post-operative)']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)', 'description': 'Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care', 'interventionNames': ['Behavioral: Enhanced Usual Care (pre-operative)', 'Behavioral: Postoperative Virtual Health Coaching', 'Behavioral: On-Track (Post-operative)']}, {'type': 'OTHER', 'label': 'Enhanced Usual Care alone', 'description': 'Only completed first randomization. Study withdrawal prior to re-randomization', 'interventionNames': ['Behavioral: Enhanced Usual Care (pre-operative)']}, {'type': 'EXPERIMENTAL', 'label': 'Preoperative Virtual Health Coaching then Usual Surgical Care', 'description': 'Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching', 'interventionNames': ['Behavioral: Preoperative Virtual Health Coaching', 'Behavioral: Usual surgical care (post-operative)']}, {'type': 'EXPERIMENTAL', 'label': 'Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching', 'description': 'Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching', 'interventionNames': ['Behavioral: Preoperative Virtual Health Coaching', 'Behavioral: Postoperative Virtual Health Coaching']}, {'type': 'EXPERIMENTAL', 'label': 'Preoperative Virtual Health Coaching then On-Track', 'description': 'Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching', 'interventionNames': ['Behavioral: Preoperative Virtual Health Coaching', 'Behavioral: On-Track (Post-operative)']}, {'type': 'EXPERIMENTAL', 'label': 'Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)', 'description': 'Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching', 'interventionNames': ['Behavioral: Preoperative Virtual Health Coaching', 'Behavioral: Postoperative Virtual Health Coaching', 'Behavioral: On-Track (Post-operative)']}, {'type': 'OTHER', 'label': 'Preoperative Virtual Health Coaching only', 'description': 'Only completed first randomization. Study withdrawal prior to re-randomization.', 'interventionNames': ['Behavioral: Preoperative Virtual Health Coaching']}], 'interventions': [{'name': 'Enhanced Usual Care (pre-operative)', 'type': 'BEHAVIORAL', 'description': 'The enhanced usual care will receive standard surgical care, and a resource brochure including basic information on health, alcohol use withdrawal risks, and treatment/emergency resources. The resource brochure will be e-mailed to patients or sent via postal mail.', 'armGroupLabels': ['Enhanced Usual Care alone', 'Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)', 'Enhanced Usual Care then On-Track', 'Enhanced Usual Care then Post-operative Health Coaching', 'Enhanced Usual Care then Usual Surgical Care']}, {'name': 'Preoperative Virtual Health Coaching', 'type': 'BEHAVIORAL', 'description': 'Preoperative Virtual Coaching is based on principles of health coaching, collaborative care, and motivational interviewing. Health and educational content is framed using the Health Belief Model. During two sessions, that take place approximately 3 and 5 weeks prior to surgery, the health coach presents alcohol use reduction/abstinence as important for surgical health (rather than addiction or chronic health reasons) and engages participants in discussion and patient-centered goal-setting.\n\nParticipants will also receive a brochure including basic information on health, alcohol use withdrawal risks, and treatment/emergency resources.', 'armGroupLabels': ['Preoperative Virtual Health Coaching only', 'Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)', 'Preoperative Virtual Health Coaching then On-Track', 'Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching', 'Preoperative Virtual Health Coaching then Usual Surgical Care']}, {'name': 'Usual surgical care (post-operative)', 'type': 'BEHAVIORAL', 'description': 'This group will receive standard post-operative care.', 'armGroupLabels': ['Enhanced Usual Care then Usual Surgical Care', 'Preoperative Virtual Health Coaching then Usual Surgical Care']}, {'name': 'Postoperative Virtual Health Coaching', 'type': 'BEHAVIORAL', 'description': 'Postoperative Virtual Coaching uses the same framework and structure as Preoperative Virtual Coaching. These sessions will be delivered by a health coach using a collaborative, and motivational interviewing-based approach. The goal of these sessions is to promote well-being and help participants maintain alcohol abstinence or reduction long-term (or initiate change in alcohol use if they have not already). These sessions promote low-risk alcohol use, provide education on chronic health effects of heavy alcohol use, and teach skills for coping with or avoiding triggers for alcohol use including coping with stress and mood challenges. These sessions introduce skills to help participants manage alcohol, stress, and mood as they recover from surgery.', 'armGroupLabels': ['Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)', 'Enhanced Usual Care then Post-operative Health Coaching', 'Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)', 'Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching']}, {'name': 'On-Track (Post-operative)', 'type': 'BEHAVIORAL', 'description': 'On-Track is a mobile and web-accessible health tool that uses self-monitoring and provision of feedback on progress towards goals to engage participants in self-management of alcohol use and motivate behavior change through increased self-awareness and accountability for health.\n\nThe On-Track application includes a) daily tracking of alcohol and other substance use; b) daily tracking of stress, mood, and pain; c) personalized health goals; and d) visual displays of alcohol use, stress, mood, pain, and goal achievement including graphs of trends over time.\n\nOn-Track also uses novel monetary and non-monetary incentives to encourage utilization including an escalating monetary incentive schedule for self-monitoring.', 'armGroupLabels': ['Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)', 'Enhanced Usual Care then On-Track', 'Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)', 'Preoperative Virtual Health Coaching then On-Track']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Fernandez, PhD', 'role': 'CONTACT', 'email': 'acfernan@med.umich.edu', 'phone': '734-232-0313'}, {'name': 'Anne Fernandez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Anne Fernandez', 'role': 'CONTACT', 'email': 'acfernan@med.umich.edu', 'phone': '734-232-0313'}], 'overallOfficials': [{'name': 'Anne Fernandez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'url': 'https://nda.nih.gov/niaaa', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The research team will share data with NIAAA data archive (NIAAADA) biannually per funder requirements. The data in the NIAAADA are catalogued and made available to the general research community at the time of an associated publication or end of the award/support period, whichever comes first. Data in the NIAAADA is available indefinitely.', 'ipdSharing': 'YES', 'description': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded investigators conducting applicable human subjects research are expected to submit de-identified, individual-level data to this data archive. The data generated in this grant will also be presented at national or international meetings (e.g., Research Society on Alcoholism, Addiction Health Services Research, etc.) and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive in PubMed Central.', 'accessCriteria': 'Community of scientists interested in the study of alcohol use and related interventions. Additionally, data submitted to National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) will be accessible by the general research community via NIAAADA.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry', 'investigatorFullName': 'Anne Fernandez', 'investigatorAffiliation': 'University of Michigan'}}}}