Safety in Dementia: An Online Caregiver Intervention

Study Overview
=================
Brief Summary
-----------------
In an online randomized trial of Safety in Dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of community-dwelling adults with dementia who have firearm access.

Detailed Description
-----------------
Aim 1: To test the efficacy of Safety in Dementia (SiD) on firearm safety decision quality and behaviors, among a national sample of informal caregivers of community-dwelling people with dementia and firearm access (n=500). Aim 2: To compare varied methods in reaching informal caregivers. Aim 3: To explore stakeholder longitudinal experiences with SiD and firearm-related decisions.

Official Title
-----------------
Safety in Dementia: An Online Caregiver Intervention

Conditions
-----------------
Caregivers, Decision Making, Alzheimer Disease, Social Media, Safety, Suicide

Intervention / Treatment
-----------------
* Behavioral: Safety in Dementia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Live in United States Speak English or Spanish Informal caregiver for community swelling person with dementia and firearm access Access to the internet Exclusion Criteria: In legal custody or institutionalized

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safety in Dementia<br>Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. | Behavioral: Safety in Dementia<br>* Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist.<br>|
| Active Comparator: Web control<br>The control group will view National Institute on Aging Home Safety Checklist. | Behavioral: Safety in Dementia<br>* Safety in Dementia is an online tool that, in a stepwise fashion, guides a caregiver individual through decisions related to firearm access for a person with dementia. It includes information and a comparison of the options and their risks and benefits. It guides the caregiver through clarification of personal feelings and values and identifying their decision/plan. The control group will view national Institute on Aging Home Safety Checklist.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Preparation for Decision Making | The Preparation for Decision Making Scale assesses perception of how useful a decision aid is in preparing for subsequent decision-making. Scores range from 1-5, calculated from the average of 9 constructs (each ranging from 1, strongly disagree to 5, strongly agree). The scale has high test reliability (0.944) and discriminates significantly between different decision support interventions. In our pilot RCT, participants had a mean score of 3.9 (SD 0.7) after viewing the SiD firearm section. | baseline/pre-intervention, 2 weeks, 2 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Decision Self-Efficacy | The Decision Self-Efficacy Scale measures confidence in ability to make decisions; transformed scores range from 0 (extremely low) to 100 (extremely high self-efficacy). | baseline/pre-intervention, 2 weeks, 2 months, 6 months | 
| Change in Firearm access | Firearm access for the person with ADRD will be assessed with scales we have used in prior work, allowing nuanced (but efficient) description of firearm access (on a scale ranging from access to multiple loaded firearms to no access to any firearms). For analysis, we will use binary categorization (any access to 1+ firearm versus no access to any firearms) | baseline/pre-intervention, 2 weeks, 2 months, 6 months | 
| Action to reduce firearm access | This will be self-report of taking action to reduce access to one or more firearms (e.g., locking of additional firearm or moving out of the home). The question and categories will allow identification of smaller, albeit important, changes; for analysis we will use binary categorization (any action versus no action). | 2 weeks, 2 months, 6 months | 
| Firearm injury | We will assess injuries or near-miss injuries (e.g., threatening situations) involving the person with ADRD and a firearm. Participants will be asked about any such incidents in the prior year (baseline) or since enrollment (follow-up) and a brief description. | baseline/pre-intervention, 2 weeks, 2 months, 6 months | 
| Caregiver burden | The short-form Zarit Burden Interview has scores ranging from 0-48, calculated from the sum of 12 items (measured on a 5-point scale from 0, never to 4, nearly always), with scores over 20 indicating high burden. | 2 weeks | 
| Positive Aspects of Caregiving | The Positive Aspects of Caregiving Scale has scores ranging from 0-36, calculated from the sum of 9 items (measured on a 5-point scale ranging from 0, disagree a lot, to 4, agree a lot, on statements such as feel more useful), with higher scores indicating more positive experiences. | 2 weeks | 
| Website analytics | Outcomes obtained from Google analytics will include average minutes spent on Safety in Dementia and specific pages viewed. | 6 months |