NCT06382194

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

April 10, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2024

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 28, 2026

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 2, 2024

Results QC Date

October 2, 2025

Last Update Submit

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

EXPERIMENTAL

Participants in this arm will receive the intervention and undergo research assessments.

Other: Decision aid

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.

Intervention Arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

DementiaLymphoma, FollicularDepression

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

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

  • Elizabeth Phelan

    University of Washington

    PRINCIPAL INVESTIGATOR

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

Locations