Decision Making Tool for Firearm Storage

April 6, 2026 updated by: Elizabeth Phelan, University of Washington

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medical record documentation of early dementia and/or depression
  • Internet or mobile device access
  • Access to firearm(s)

Exclusion Criteria:

• Active suicidality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Participants in this arm will receive the intervention and undergo research assessments.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Any Improvement in Safe Firearm Storage (Adapted From the National Firearm Survey)
Time Frame: Assessed at 4 weeks post enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Low-Literacy Decisional Conflict Scale Score
Time Frame: Assessed at 4 weeks post enrollment
Measured by the Low Literacy Decisional Conflict Scale. This is a 10-item scale. Response options for each item are yes (0), no (4), unsure (2). Score range is from 0 (no decisional conflict) to 40 (extremely high decisional conflict). Lower scores represent a better outcome.
Assessed at 4 weeks post enrollment
Change From Baseline in Firearm Safe Storage Knowledge Questionnaire Score
Time Frame: Assessed at 4 weeks post enrollment
A measure of participant understanding of firearm safe storage, alternatives, rationale, risks and benefits. Each questionnaire item is given a score value of 1 (if participant correctly selects 'true' or 'false') or zero (if participant selects the incorrect answer or selects 'unsure'). Item values are totaled to obtain an overall knowledge score. Minimum score is 0 and maximum score is 8, with higher scores representing a better outcome.
Assessed at 4 weeks post enrollment
Number of Participants Who Access the Intervention
Time Frame: Assessed at 4 weeks post enrollment
Number of participants who access and report watching the decision aid intervention at follow-up
Assessed at 4 weeks post enrollment
Mean Score on the Acceptability of Intervention Measure
Time Frame: Assessed at 4 weeks post enrollment
A 4-item measure of the intervention's acceptability from the perspective of the participants, assessed at follow-up. The response option for each item is a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree). The score for the scale is calculated as the average of responses on the 4 items. The minimum score on the scale is 1, and the maximum score is 5. Higher scores represent a better outcome.
Assessed at 4 weeks post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Elizabeth Phelan, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Actual)

October 9, 2024

Study Completion (Actual)

October 9, 2024

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00014522
  • 1R21AG076362-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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