A Randomized Controlled Trial of a Care Partner-Centered Structured Retrieval Practice Intervention for Dementia Caregiver Education and Well-Being
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Caregiver Knowledge Retention
研究概览
简要总结
Caring for a person living with dementia can be stressful, and many family caregivers report limited access to effective educational resources for managing dementia-related behaviors and caregiver stress. This study will evaluate a learning-based educational intervention called structured retrieval practice (SRP), which is designed to improve long-term learning by encouraging repeated recall of information with feedback. Informal dementia caregivers will be randomly assigned to learn caregiving and self-care strategies using either SRP or a traditional reading-based educational approach. Participants will be assessed on their knowledge, confidence in caregiving skills, stress levels, and perceptions of dementia-related behavioral symptoms over multiple follow-up periods. The study will also examine whether the SRP intervention is feasible and acceptable for caregivers in real-world settings.
详细描述
Caring for someone with dementia is often associated with high levels of stress, particularly when caregivers lack knowledge about how to manage behavioral and psychological symptoms of dementia (BPSD). Although educational resources for dementia caregivers are widely available, many are not designed using evidence-based learning principles that support long-term retention and application of information. Structured retrieval practice (SRP) is a learning strategy that enhances durable learning by requiring individuals to actively recall information over time while receiving corrective feedback.
This study is a longitudinal randomized controlled trial comparing an SRP-based educational intervention to a traditional reading-based education control condition. Informal caregivers of individuals living with dementia will be randomly assigned to one of two parallel arms. Both groups will receive educational content focused on managing dementia-related behavioral symptoms, coping strategies, and caregiver self-care; however, the format of instruction will differ by condition.
Outcomes will be assessed at baseline, and at 2-day, 2-week, and 2-month follow-up time points. Primary outcomes include caregiver knowledge retention, caregiving self-efficacy, perceived stress, and caregiver-reported severity of dementia-related behavioral symptoms. In addition, the study will evaluate intervention feasibility, acceptability, and adherence using self-report measures and backend program usage data.
Data will be collected either remotely or in person, depending on participant preference. The findings from this study will inform the development of evidence-based educational approaches that may be integrated into existing caregiver education programs and digital tools to better support families caring for individuals with dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is a single-blind study in which outcome assessors and data analysts are blinded to participant condition assignment. Participants are aware of their assigned learning format but are not informed of specific study hypotheses.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 50 years or older
- •Informal (unpaid) caregiver for a family member or friend living with dementia
- •Providing ongoing assistance or support to the individual with dementia
- •Reports moderate to high perceived stress, defined as a score of 14 or higher on the Perceived Stress Scale (PSS-10)
- •Able to speak and read English
- •Able to complete study procedures either in person or remotely
- •Has access to a computer, tablet, or smartphone with internet access
- •Willing and able to provide informed consent
排除标准
- •Paid or professional caregivers (e.g., home health aides)
- •Caregivers younger than 50 years of age
- •Caregivers reporting low perceived stress (PSS-10 score below 14)
- •Caregivers providing assistance to an individual without evidence of cognitive - impairment, as determined by a dementia screening interview (AD8 score < 2)
- •Inability to complete study procedures due to cognitive, sensory, or technological limitations
- •Failure to meet study screening requirements or provide informed consent
研究组 & 干预措施
Structured Retrieval Practice (SRP)
Participants assigned to this arm will receive caregiver education delivered using structured retrieval practice (SRP). Educational content will be presented through repeated opportunities to actively recall information over time with corrective feedback. Content will focus on managing behavioral and psychological symptoms of dementia, coping strategies, and caregiver self-care.
干预措施: Structured Retrieval Practice (Behavioral)
Reading-Based Education Control
Participants assigned to this arm will receive caregiver education delivered through traditional reading-based materials. Educational content will cover the same topics as the structured retrieval practice arm, including management of dementia-related behavioral symptoms, coping strategies, and caregiver self-care, but without retrieval practice or corrective feedback.
干预措施: Reading-Based Education (Behavioral)
结局指标
主要结局
Caregiver Knowledge Retention
时间窗: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
Caregiver knowledge retention will be assessed using a researcher-developed multiple-choice assessment designed to measure factual and applied knowledge related to dementia symptom management and caregiver stress management. The assessment will consist of 64 items written at or below an 8th-grade reading level and tailored to each participant's selected learning content. Scores will reflect the total number of items answered correctly, with higher scores indicating greater knowledge retention.
Caregiver Self-Efficacy
时间窗: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
Caregiver self-efficacy will be measured using the Revised Scale for Caregiving Self-Efficacy (RSCSE). The RSCSE is a validated self-report instrument assessing caregivers' confidence in managing stress, responding to disruptive behaviors, and controlling upsetting thoughts. The measure includes three subscales, each consisting of five items rated on a 0% to 100% confidence scale. Subscale scores will be summed to create composite indices, with higher scores indicating greater caregiving self-efficacy.
Caregiver Perceived Stress
时间窗: Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention
Caregiver perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), a widely used self-report measure of perceived stress. Participants rate items on a 5-point Likert scale based on the frequency of stress-related experiences in the past month. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
次要结局
- Caregiver-Reported Dementia-Related Behavioral Symptoms(Baseline; 2 days post-intervention; 2 weeks post-intervention; 2 months post-intervention)
- Intervention Acceptability and Satisfaction(Immediately after completion of the intervention session.)
- Intervention Adherence(During intervention period)