Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT06382194
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2024-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decision Making Tool for Firearm Storage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-17', 'releaseDate': '2025-10-02'}, {'releaseDate': '2025-12-08'}], 'estimatedResultsFirstSubmitDate': '2025-10-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003661', 'term': 'Decision Support Techniques'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-19', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Firearm storage (adapted from the National Firearm Survey)', 'timeFrame': 'Assessed at 4 weeks post enrollment', 'description': 'An ordinal measure of how firearms are stored (from relinquishment to loaded/unlocked)'}], 'secondaryOutcomes': [{'measure': 'Low-Literacy Decisional Conflict Scale', 'timeFrame': 'Assessed at 4 weeks post enrollment', 'description': 'Measured by the Low Literacy Decisional Conflict Scale. This is a 10-item scale comprised of 4 subscales. Response options for each item are yes, no, unsure. Score range is from 0 (no decisional conflict) to 100 (extremely high decisional conflict).'}, {'measure': 'Knowledge Questionnaire', 'timeFrame': 'Assessed at 4 weeks post enrollment', 'description': "A measure of participant understanding of firearm safe storage, alternatives, rationale, risks and benefits. Each item is given a score value of 1 (if participant correctly selects 'true' or 'false') or zero (if selects the incorrect answer or selects 'unsure'). Items are totaled to obtain an overall knowledge score."}, {'measure': 'Feasibility of intervention delivery', 'timeFrame': 'Assessed at 4 weeks post enrollment', 'description': 'Number of participants who access and view the entire decision aid'}, {'measure': 'Acceptability of Intervention Measure', 'timeFrame': 'Assessed at 4 weeks post enrollment', 'description': "A 4-item measure of the intervention's acceptability. The response option for each item is a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia, Mild', 'Depression']}, 'descriptionModule': {'briefSummary': 'This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage.', 'detailedDescription': 'This pilot study will test the feasibility and acceptability of a decision aid about safe firearm storage with firearm-owning persons with early dementia and/or depression'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical record documentation of early dementia and/or depression\n* Internet or mobile device access\n* Access to firearm(s)\n\nExclusion Criteria:\n\n• Active suicidality'}, 'identificationModule': {'nctId': 'NCT06382194', 'briefTitle': 'Decision Making Tool for Firearm Storage', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': "Shared Decision Making for Firearm Safety Among Older Adults With Early Changes Associated With Alzheimer's Disease/Alzheimer's Disease-Related Dementias (AD/ADRD)", 'orgStudyIdInfo': {'id': 'STUDY00014522'}, 'secondaryIdInfos': [{'id': '1R21AG076362-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21AG076362-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Participants in this arm will receive the intervention and undergo research assessments.', 'interventionNames': ['Other: Decision aid']}], 'interventions': [{'name': 'Decision aid', 'type': 'OTHER', 'description': 'The intervention is a newly developed decision aid designed to guide decisions about storage of firearms among older gun owners with early dementia and/or depression.', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Elizabeth Phelan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Division of Gerontology and Geriatric Medicine', 'investigatorFullName': 'Elizabeth Phelan', 'investigatorAffiliation': 'University of Washington'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-10-02', 'type': 'RELEASE'}, {'date': '2025-10-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Elizabeth Phelan, Professor, Division of Gerontology and Geriatric Medicine, University of Washington'}}}}