Study Stopped
Recruitment to the study was determined to not be feasible
Decision Making Tool for Firearm Storage
Shared Decision Making for Firearm Safety Among Older Adults With Early Changes Associated With Alzheimer's Disease/Alzheimer's Disease-Related Dementias (AD/ADRD)
2 other identifiers
interventional
5
1 country
1
Brief Summary
This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2024
CompletedStudy Start
First participant enrolled
April 10, 2024
CompletedFirst Posted
Study publicly available on registry
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2024
CompletedResults Posted
Study results publicly available
April 28, 2026
CompletedApril 28, 2026
April 1, 2026
6 months
April 2, 2024
October 2, 2025
April 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Any Improvement in Safe Firearm Storage (Adapted From the National Firearm Survey)
Data were reported on an ordinal scale (0=unlocked and loaded; 1=unlocked and unloaded; 2=locked and loaded; 3=locked and unloaded; 4=removed from house). Any improvement on the ordinal scale from baseline to follow-up was dichotomized (0=no improvement; 1=any improvement in safe firearm storage).
Assessed at 4 weeks post enrollment
Secondary Outcomes (4)
Change From Baseline in the Low-Literacy Decisional Conflict Scale Score
Assessed at 4 weeks post enrollment
Change From Baseline in Firearm Safe Storage Knowledge Questionnaire Score
Assessed at 4 weeks post enrollment
Number of Participants Who Access the Intervention
Assessed at 4 weeks post enrollment
Mean Score on the Acceptability of Intervention Measure
Assessed at 4 weeks post enrollment
Study Arms (1)
Intervention Arm
EXPERIMENTALParticipants in this arm will receive the intervention and undergo research assessments.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Medical record documentation of early dementia and/or depression
- Internet or mobile device access
- Access to firearm(s)
You may not qualify if:
- Active suicidality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Enrollment in the clinical trial did not reach the target number of participants needed to achieve target power and was insufficient to produce statistically reliable results.
Results Point of Contact
- Title
- Elizabeth Phelan or Laura Prater
- Organization
- University of Washington (Phelan)/ The Ohio State University (Prater)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Phelan
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Division of Gerontology and Geriatric Medicine
Study Record Dates
First Submitted
April 2, 2024
First Posted
April 24, 2024
Study Start
April 10, 2024
Primary Completion
October 9, 2024
Study Completion
October 9, 2024
Last Updated
April 28, 2026
Results First Posted
April 28, 2026
Record last verified: 2026-04