Development of a Dyadic Stress Management Toolkit for People Living With Dementia and Their Care Partners
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Participant perceived benefit with toolkit, as assessed using a toolkit benefit scale
研究概览
简要总结
The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home.
A human-centered design approach will be used to develop and user-test a prototype of a dyadic, tangible stress-management toolkit with and for PLWD and their care partners; and to explore the feasibility of collecting several stress-related outcomes. A total of 4 focus groups (n=3-4 dyads/group) will be convened to explore the experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. Ten dyads who were not involved in prototype development will then use the toolkit for 2 weeks. Feedback on usability, feasibility, and acceptability will be collected through questionnaires (end of weeks 1 and 2) and 3 focus groups (3-4 dyads/group at end of week 2). We will collect stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and saliva biospecimens from participants with dementia and their care partners at baseline and end of week 2, to explore their utility as endpoints in a future toolkit intervention that uses a single-arm, pre-post study design. Results will yield valuable data to support development and preliminary testing of a stress management toolkit intervention in a future pilot study.
This study involves human subjects and is expected to yield no more than minimal risk. Tools eligible for the toolkit must have demonstrated high degrees of safety in prior research. Major risks for participation include the potential for negative emotional responses to focus group discussions and surveys pertaining to stress, excess time burden to participate in the study, and breach of confidentiality. It is not anticipated, but there is a potential for physical discomfort if tools are not used as directed, which is why the toolkits will include a user guide outlining safety information, which a research team member will review with each participant prior to use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Participant perceived benefit with toolkit, as assessed using a toolkit benefit scale
时间窗: Within 1 week after user-testing period
Investigator developed multi-item benefit scale will include Likert-scaled items pertaining to perceived benefit from the toolkit among participants in the user-testing arm; item ranges 1=not beneficial at all to 5 very beneficial). Scores will be averaged to yield and overall benefit score with higher scores indicating a greater degree of benefit.
Participant satisfaction with toolkit, as assessed using a toolkit satisfaction scale
时间窗: Within 1 week after user-testing period
Investigator developed multi-item satisfaction scale will include Likert-scaled items pertaining to satisfaction with design and delivery of the toolkit among participants in the user-testing arm; item ranges 1=not satisfied at all to 5 very satisfied). Scores will be averaged to yield and overall satisfaction score with higher scores indicating a greater degree of satisfaction.
Enrollment rate
时间窗: Through study completion, an average of 1 year
Percentage of participant dyads enrolled/dyads screened in user-testing arm.
Withdrawal rate
时间窗: Through study completion, an average of 1 year
Percentage of dyads that withdraw/dyads enrolled in user-testing arm.
Frequency of adverse events and injuries
时间窗: Through study completion, an average of 1 year
Number of adverse events and injuries reported in user-testing arm.
Frequency of toolkit use
时间窗: End of week 2 of user-testing period
Number of days toolkit was used over the last week (range 0-7) will be assessed among participants enrolled in user-testing arm.
次要结局
- Percentage of participant completion of dyadic relationship strain outcome measure, as assessed using the Dyadic Relationship Scale(Within 1 week after user-testing period)
- Percentage of participant completion of neuropsychiatric symptoms of dementia outcome measure, as assessed using the Neuropsychiatric Inventory-Questionnaire(Within 1 week after user-testing period)
- Percentage of participant completion of caregiver stress outcome measure, as assessed using the Perceived Stress Scale(Within 1 week after user-testing period)
- Percentage of participant completion of physiologic stress outcome measure, as assessed through salivary cortisol biospecimens(Within 1 week after user-testing period)