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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG076362-01 | U.S. NIH Grant/Contract | View source |
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Recruitment to the study was determined to not be feasible
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Participants in this arm will receive the intervention and undergo research assessments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision aid | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at 4 weeks post enrollment |
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Inclusion Criteria:
Exclusion Criteria:
• Active suicidality
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Phelan | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Participants in this arm will receive the intervention and undergo research assessments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Participants in this arm will receive the intervention and undergo research assessments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | This is reporting the percentage of participants with an improvement in safe firearm storage. | Posted | Count of Participants | Participants | Assessed at 4 weeks post enrollment |
|
From enrollment until end of follow-up, up to 4 weeks
We added avoidance of routine preventive care, increased stress from removal/reduced access to firearms, injuries related to home invasion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | Participants in this arm will receive the intervention and undergo research assessments. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury related to home invasion | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Avoidance of routine primary care | Social circumstances | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Phelan or Laura Prater | University of Washington (Phelan)/ The Ohio State University (Prater) | 614-292-3218 | prater.144@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2024 | Jan 27, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2024 | Oct 28, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D008224 | Lymphoma, Follicular |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 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. | 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 | 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. | Assessed at 4 weeks post enrollment |
| Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Number of Participants meeting MoCA criteria for Mild Cognitive Impairment | Meets criteria for Mild Cognitive Impairment, as Indicated by scoring 18-25 on the MoCA scale | Number | participants |
|
| Number with Diagnosed Depression (ICD-10 code) | Participant medical record reflects an ICD-10 code for Depression | Number | participants |
|
| Age, Customized | Age 60 years or older | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 4 weeks post enrollment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 4 weeks post enrollment |
|
|
|
| Secondary | Number of Participants Who Access the Intervention | Number of participants who access and report watching the decision aid intervention at follow-up | Posted | Count of Participants | Participants | Assessed at 4 weeks post enrollment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 4 weeks post enrollment |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| Increased stress from removal of firearm from the home | Social circumstances | Systematic Assessment |
|
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| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |