"Safety in Dementia": An Online Caregiver Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in Preparation for Decision Making
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Live in United States
- •Speak English or Spanish
- •Informal caregiver for community swelling person with dementia and firearm access
- •Access to the internet
排除标准
- •In legal custody or institutionalized
研究组 & 干预措施
Safety in Dementia
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.
干预措施: Safety in Dementia (Behavioral)
Web control
The control group will view National Institute on Aging Home Safety Checklist.
干预措施: Safety in Dementia (Behavioral)
结局指标
主要结局
Change in Preparation for Decision Making
时间窗: During baseline assessment (specifically, after receiving randomization allocation), 2 weeks, 2 months, 6 months
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.
次要结局
- Change in Decision Self-Efficacy(baseline/pre-intervention, 2 weeks, 2 months, 6 months)
- Firearm injury(baseline/pre-intervention, 2 weeks, 2 months, 6 months)
- Change in Firearm access(baseline/pre-intervention, 2 weeks, 2 months, 6 months)
- Action to reduce firearm access(2 weeks, 2 months, 6 months)
- Caregiver burden(2 weeks)
- Website analytics(6 months)
- Positive Aspects of Caregiving(2 weeks)