Dementia, MildNCT06382194
Decision Making Tool for Firearm Storage
A study testing Decision aid in people with Dementia, Mild and Depression, run by University of Washington at 1 site in United States.
Trial summary
This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Mild, Depression
- What is being tested?
- Decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 9 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Medical record documentation of early dementia and/or depression
- Internet or mobile device access
- Access to firearm(s)
Who cannot join
- Active suicidality
Trial locations and contacts
1 site in 1 country.
About this study
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)
This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage.
Read the 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
- Conditions
- Dementia, Mild, Depression
- Being tested
- Decision aid
- Medical subject headings
- Dementia, Lymphoma, Follicular, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants in this arm will receive the intervention and undergo research assessments. Receives: Other: Decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessed at 4 weeks post enrollment
Secondary outcomes (4)
Change From Baseline in the Low-Literacy Decisional Conflict Scale Score
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.
Measured: Assessed at 4 weeks post enrollment
Change From Baseline in Firearm Safe Storage Knowledge Questionnaire Score
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.
Measured: Assessed at 4 weeks post enrollment
Number of Participants Who Access the Intervention
Number of participants who access and report watching the decision aid intervention at follow-up
Measured: Assessed at 4 weeks post enrollment
Mean Score on the Acceptability of Intervention Measure
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.
Measured: Assessed at 4 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start10 Apr 2024
- Primary completion9 Oct 2024
- Study completion9 Oct 2024
Why it stopped: Recruitment to the study was determined to not be feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dementia, MildStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Elizabeth Phelan, University of Washington
- Investigators
- Elizabeth Phelan, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382194
- Sponsor's protocol ID
- STUDY00014522
- Other IDs
- 1R21AG076362-01
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2024
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06382194
- Acronym / sponsor ID
- STUDY00014522
- Conditions
- Dementia, Mild, Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment to the study was determined to not be feasible
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Posted 28 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Decision aidParticipants in this arm will receive the intervention and undergo research assessments. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Medical record documentation of early dementia and/or depression
- Internet or mobile device access
- Access to firearm(s)
Key exclusion criteria (1 listed)
- Active suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidThe 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. | Other | Intervention Arm |
Primary outcome
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).
4 secondary outcomes
Change From Baseline in the Low-Literacy Decisional Conflict Scale Score
Time frame: Assessed at 4 weeks post enrollment
Change From Baseline in Firearm Safe Storage Knowledge Questionnaire Score
Time frame: Assessed at 4 weeks post enrollment
Number of Participants Who Access the Intervention
Time frame: Assessed at 4 weeks post enrollment
Mean Score on the Acceptability of Intervention Measure
Time frame: Assessed at 4 weeks post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Phelan principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Dementia, Mild and Depression, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Improvement in Safe Firearm Storage (Adapted From the National Firearm Survey) (time frame: Assessed at 4 weeks post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.