E-Tailored Pain Management Support for Dementia Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Caregiver Self-Efficacy in Pain Management
研究概览
简要总结
The goal of this clinical trial is to test whether a web-based application called the Pain Control Enhancement App (PACE-app) can support family caregivers in managing pain for their care recipients with dementia. The main questions it aims to answer are:
Is it feasible and acceptable for family caregivers to use the PACE-app?
Does using the PACE-app improve caregiver self-efficacy in pain management, adherence to pain treatments, communication with care providers, well-being, and their care recipient's pain conditions?
Researchers will compare caregivers who use the PACE-app to those who continue with their usual care practices to see if the app leads to better outcomes for both caregivers and care recipients.
Participants will:
Be randomly assigned to either the PACE-app group or a usual-care control group
Complete online surveys at baseline, 1 month, and 2 months
If assigned to the PACE-app group:
Use the PACE-app for 1 month to receive tailored pain management strategies and tools, and record their care recipient's pain in a digital diary
Participate in an interview about their experience with the app
All participation activities can be done remotely or in person.
详细描述
This randomized controlled trial will assess the feasibility, usability, and preliminary efficacy of the Pain Control Enhancement App (PACE-app), a web-based intervention designed to support family caregivers of persons with dementia in managing pain. The trial will also explore mechanisms through which the PACE-app may affect caregiver and care recipient outcomes.
Uncontrolled pain is common in people with dementia and presents unique challenges for caregivers, particularly those with limited access to specialized healthcare services. Family caregivers often lack adequate knowledge, skills, and support to manage pain effectively, contributing to suboptimal outcomes for both caregivers and care recipients.
The PACE-app provides tailored, technology-based pain management support that includes:
Screening of caregiver-specific challenges in pain management;
Personalized pain management strategies based on the screening results;
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be a primary caregiver - (a family member, relative, or friend) of a person with dementia (or cognitive impairment) and chronic pain (lasting >3 months)'
- •Be responsible for managing the care recipient's pain and pain treatments (including interpreting verbal or non-verbal pain communication).
- •Be age 18 -
- •Be able to read and speak English.
- •Have regular access to an electronic device (tablet, laptop, or computer) with internet connectivity (for using the app and participating in data collection).
- •Be accessible by phone or email to schedule meetings.
- •Be willing to commit to the full study duration and protocol.
排除标准
- •Currently participating in another research study that could interfere with this intervention.
研究组 & 干预措施
Usual Care Group
Care recipients will continue receiving their regular pain care. Caregivers will complete outcome assessments only.
Introductory Meeting (Baseline):
Caregivers will attend a 1.5-hour meeting to complete informed consent and baseline REDCap surveys.
Follow-up (Month 1 and Month 2):
At 1-month and 2-month follow-ups, caregivers will independently complete REDCap surveys (~45 minutes per follow-up).
干预措施: Usual Pain Management Care (Behavioral)
App Use Group
Care recipients will continue receiving their regular pain care. Caregivers will use the PACE-app and complete outcome assessments.
Introductory Meeting (Baseline):
Caregivers will attend a 1.5-hour meeting to complete informed consent and baseline REDCap surveys.
Intervention Period (Month 1):
Caregivers will use the PACE-app for 1 month, complete a daily pain diary (5-10 minutes/day), and access weekly summary reports to share with providers.
Post-Intervention (Month 1):
Caregivers will complete REDCap surveys and participate in a 1.5-hour interview on their experience with the app (audio-recorded unless declined).
Follow-up (Month 2):
Caregivers will complete the same REDCap questionnaires to assess longer-term outcomes.
干预措施: Web-based pain management support tool (Other)
结局指标
主要结局
Caregiver Self-Efficacy in Pain Management
时间窗: Change from baseline to 1 month and 2 months
Measured using the pain managment subscale of the Chronic Pain Self-Efficacy Scale (CPSS). This 7-item scale on a 10-100 scale assesses confidence in skills such as medication management, and non-pharmacological techniques. Higher scores indicate greater self-efficacy
次要结局
- Caregiver Knowledge in Pain Management(Baseline, 1 month, 2 months)
- Caregiver adherence to Pain Treatments(Baseline, 1 month, 2 moths)
- Caregiver Burden(Baseline, 1 month, 2 months)
- Caregiver Stress(Baseline, 1 month, 2 months)
- Caregiver Depression(Baseline, 1 month, 2 months)
- Caregiver Communication with Providers(Baseline, 1 month, 2 months)
研究者
Nai-Ching Chi
Associate Professor
University of Iowa