Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-02 @ 9:59 AM
Study NCT ID:
NCT06848504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-27
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MedSMA℞T Mobile ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 244}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study', 'timeFrame': 'Baseline, 3, 6, and 9 months.', 'description': 'The fourth factor of the Adolescent Opioid Safety and Learning (AOSL) scale, Opioid Harm, measures understanding of negative social and professional effects of opioid misuse. Scores range from 3-15, where 3 indicates the lowest level of overall opioid harm awareness and 15 is the highest level.'}], 'secondaryOutcomes': [{'measure': 'Change in Safe Opioid Storage Behaviour over 9 months', 'timeFrame': 'Baseline, 3, 6, and 9 months.', 'description': 'This outcome contains 4 items from the Wisconsin Strategic Prevention Framework Partnerships for Success Community Survey - V02, comprised of yes/no questions. The minimum score for this scale is 0 (indicating least safe opioid storage behaviour) and the maximum is 4 (indicating most safe opioid storage behaviour).'}, {'measure': 'Change in Opioid Disposal Behaviour over 9 months', 'timeFrame': 'Baseline, 3, 6, and 9 months.', 'description': 'This outcome contains 6 items from the Wisconsin Strategic Prevention Framework Partnerships for Success Community Survey - V02, and includes yes/no questions. The minimum score for this scale is 0 (indicating least safe opioid disposal behaviour) and the maximum is 6 (indicating most safe opioid disposal behaviour).'}, {'measure': 'Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months', 'timeFrame': 'Baseline, 3, 6, and 9 months.', 'description': 'This section covers the second factor, Learning About Medication, of the Medication Understanding and Use Self-Efficacy (MUSE) scale. This factor is comprised of 4 items, each scored 1-4. The minimum score is 4, and the maximum is 16. A score of 4 indicates lower understanding and self-efficacy in opioid use, whereas a score of 16 indicates highest level of understanding and self-efficacy in opioid use.'}, {'measure': 'Change in Family Communication Behaviour Patterns over 9 months', 'timeFrame': 'Baseline, 3, 6, and 9 months.', 'description': 'This includes both the parent and child versions of the 26-item, 2-factor scales. The first factor, Conversation orientation, contains 15 items. The second factor, Conformity orientation, contains 11 items. Items are scored from 1-5, where 1 is "Disagree Strongly" and 5 is "Agree Strongly". Scale scores are averages for the two scales, with each item contributing equally. The minimum and maximum average scores, therefore, cannot exceed 1 and 5, respectively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid Education', 'Opioid Use Disorder', 'Opiate-Related Disorders', 'Opiate', 'Opioid', 'Serious Game', 'Smartphone', 'Smartphone Game', 'Medication safety', 'Adolescent Health'], 'conditions': ['Opiate-Related Disorders', 'Opiate Use Disorder', 'Opioid']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is:\n\n• Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone?\n\nParticipants will, in addition to receiving opioid counseling:\n\n* Join an online meeting with research staff to test the smartphone-based intervention\n* Report demographic information\n* Complete surveys about opioids\n* Complete a family medication safety plan\n* Complete surveys after 3, 6, and 9 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults who receive an opioid prescription from a study Emergency Department, AND\n* who report having an adolescent, aged 12-18, living at home, AND\n* who speak and understand English\n* Each participant must have the ability to provide informed consent\n\nExclusion Criteria:\n\n* Adults who do not receive an opioid prescription from a study Emergency Department AND/OR\n* who do not have an adolescent, aged 12-18, living at home, AND/OR\n* who do not speak or understand English\n* Adults and/or adolescents who do not have the ability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06848504', 'briefTitle': 'MedSMA℞T Mobile ED', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Implementing MedSMA℞T Families in the Emergency Department Setting: A Game-based Approach for Improving Opioid Safety Among Adolescents and Parents', 'orgStudyIdInfo': {'id': '98853'}, 'secondaryIdInfos': [{'id': 'R18HS030202', 'link': 'https://reporter.nih.gov/quickSearch/R18HS030202', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This group will receive the intervention of interest, MedSMA℞T Mobile, in addition to standard opioid-related counseling. MedSMA℞T Mobile is a serious game (intended to educate while entertaining) focused on opioid safety.', 'interventionNames': ['Behavioral: MedSMA℞T Mobile']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department.'}], 'interventions': [{'name': 'MedSMA℞T Mobile', 'type': 'BEHAVIORAL', 'description': 'MedSMA℞T Mobile is an innovative mobile digital health intervention that integrates technology-based learning to facilitate family communication and creation of a personalized Family Medication Safety Plan. The Family Medication Safety Plan (FMSP) is a tool for families to record important information about their medications and create a plan for safe use, storage, and disposal. Participants will play MedSMA℞T Mobile for up to 30 minutes at the first study visit.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61104', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Deanna Berg', 'role': 'CONTACT', 'email': 'DBerg3@uwhealth.org', 'phone': '779-696-6152'}, {'name': 'Jessica Scott', 'role': 'CONTACT', 'email': 'JScott@uwhealth.org', 'phone': '779-696-4243'}], 'facility': 'Swedish American Hospital', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '53718', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Melanie Hankes', 'role': 'CONTACT', 'email': 'MHankes@uwhealth.org', 'phone': '608-890-9098'}, {'name': 'Kayla Zubke', 'role': 'CONTACT', 'phone': '608-421-7367'}], 'facility': 'East Madison Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Allie Hurst', 'role': 'CONTACT', 'email': 'ahurst@medicine.wisc.edu', 'phone': '608-263-3258'}, {'name': 'Allie Hurst, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Olufunmilola Abraham, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky College of Pharmacy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olufunmilola Abraham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Olufunmilola Abraham', 'investigatorAffiliation': 'University of Kentucky'}}}}