Decision Making Tool for Firearm Storage

Depression Clinical Trial

Official title:

Shared Decision Making for Firearm Safety Among Older Adults With Early Changes Associated With Alzheimer's Disease/Alzheimer's Disease-Related Dementias (AD/ADRD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382194
• Other study ID #: STUDY00014522
• Secondary ID: 1R21AG076362-01
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: University of Washington
• Contact: Rachel Ross
• Phone: (509) 596-1438
• Email: rross4[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Medical record documentation of early dementia and/or depression

• Internet or mobile device access

• Access to firearm(s)

Exclusion Criteria:

• Active suicidality

Related Conditions & MeSH terms

• Dementia
• Dementia, Mild
• Depression

Intervention

Other:
• Decision aid
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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Firearm storage (adapted from the National Firearm Survey)	An ordinal measure of how firearms are stored (from relinquishment to loaded/unlocked)	Assessed at 4 weeks post enrollment
Secondary	Low-Literacy Decisional Conflict Scale	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).	Assessed at 4 weeks post enrollment
Secondary	Knowledge Questionnaire	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.	Assessed at 4 weeks post enrollment
Secondary	Feasibility of intervention delivery	Number of participants who access and view the entire decision aid	Assessed at 4 weeks post enrollment
Secondary	Acceptability of Intervention Measure	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).	Assessed at 4 weeks post enrollment