Virtual Coaching to Maximize Dementia Caregivers' Respite Time-Use: A Stage 1 Pilot Test for Feasibility and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"
研究概览
简要总结
The "Time for Living & Caring" (TLC) intervention is an online, self-administered intervention, with the purpose of providing informal family caregivers with resources, support, and education to maximize the benefit of their respite time-use (respite is defined as planned time away from caregiving; it can be provided by a formal service provider or informal arrangements within families/networks). The study will use a full-powered pilot sample (anticipated n=150; actual n=166) and a randomized waitlist control design to examine feasibility and initial efficacy of the TLC intervention.
详细描述
The purpose of this study is to redevelop the Time for Living and Caring (TLC) intervention, in which dementia caregivers are taught strategies to assess and identify ways to spend upcoming periods of respite time, to a fully online, self-administered virtual coaching format, and then to pilot-test the new TLC intervention for feasibility and efficacy.
Aim 1 is to modify, adapt, and refine the existing intervention modules, utilizing a community-engaged design process where stakeholders (i.e., current or former caregivers, diverse community leaders, and respite providers) will work as consultants alongside the research, technical, and creative teams to develop and provide feedback on the TLC prototypes. The primary endpoint of this phase of the study is a fully-developed, tested, and ready-to-launch web-based intervention.
Aim 2 is to conduct a pilot test with dementia caregivers who are currently using respite, using a full powered pilot sample and a randomized waitlist-control experimental design where participants are exposed to the redeveloped TLC intervention for 8 weeks and will provide assessments of daily respite use, respite time-use satisfaction, and wellbeing. These pilot data will be used to assess feasibility and to explore hypotheses regarding the potential efficacy of the intervention as well as the mechanism - time-use satisfaction -underlying the intervention's effect on wellbeing. **Aim 2 uses a clinical trial methodology, and is therefore the part of the study that is described in detail here **
Aim 3 is intended to explore future implementation with respite providers, as yet another assessment of the intervention's feasibility. We will host webinars to demonstrate the features and functionality of the TLC intervention. We will then ask providers for feedback on their likelihood of implementation and barriers to using TLC with their clients.
Together, these three aims represent a comprehensive approach to Stage 1 behavioral intervention research activities, with the overall goal of (re)developing an intervention that is useful to dementia caregivers and is scalable to real world applications. Each aim has a separate sample and study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •caregivers to persons with Alzheimer's Disease or Related Dementia (AD/ADRD) (self-identified)
- •use formal or informal respite for at least 4 hours per week.
- •primary caregiver (self-identified)
- •co-residing with the care recipient
- •18 years or older AND
- •able to read and write in English.
排除标准
- •caregivers to persons with disability or chronic condition, and not Alzheimer's Disease and Related Dementia (AD/ADRD)
- •caregivers who do not use respite for at least 4 hours per week
- •noncoresidential caregivers
- •younger than 18 years
- •not able to read and write in English
结局指标
主要结局
Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"
时间窗: Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Self-report multi-item index (24 items; range 0-96). Lower scores indicate lower levels of caregiver burden. Higher scores indicate higher levels of perceived burden associated with caregiving tasks.
Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form
时间窗: Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Anxiety was measured with the PROMIS Anxiety short-form questionnaire for adults, a self-report, 8-item additive scale that standardizes the distribution of anxiety-related symptoms (T-score) on a population-distribution with a mean of 50 and standard deviation of 10: "During the past 7 days, I felt nervous, anxious, fearful, uneasy, tense, worried, unable to focus on anything other than my anxiety, felt like I needed help with my anxiety" each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of anxiety.
次要结局
- Respite Time-Use (in Hours Per Week)(Pre-Intervention (baseline, week 1) and Post-Intervention (week-16) for both Group A and Group B)
- Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement "I am Happy With What I Choose to do During Respite"(Pre-Intervention (baseline, week 1) and Post-Intervention (week 16) for both Group A and Group B)
研究者
Rebecca Utz
Associate Professor
University of Utah