Dementia, Mild, Depression
Conditions
Brief summary
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
Interventions
OTHERDecision 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.
Sponsors
University of Washington
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medical record documentation of early dementia and/or depression * Internet or mobile device access * Access to firearm(s)
Exclusion criteria
• Active suicidality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Improvement in Safe Firearm Storage (Adapted From the National Firearm Survey) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Low-Literacy Decisional Conflict Scale Score | 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. |
| Change From Baseline in Firearm Safe Storage Knowledge Questionnaire Score | 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. |
| Number of Participants Who Access the Intervention | Assessed at 4 weeks post enrollment | Number of participants who access and report watching the decision aid intervention at follow-up |
| Mean Score on the Acceptability of Intervention Measure | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth Phelan
University of Washington
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age 60 or older | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Number of Participants meeting MoCA criteria for Mild Cognitive Impairment | 1 participants |
| Number with Diagnosed Depression (ICD-10 code) | 5 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
None listed