Reminiscence, Anxiety and Early Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Acceptability of SR and AC
研究概览
简要总结
This study seeks to establish the acceptability and evaluate the limited efficacy of Simple Reminiscence (SR), a home-delivered non-pharmacological intervention designed to relieve stress, improve affect, and prevent or quell disruptive or maladaptive behaviors in community-residing individuals diagnosed with early Alzheimer's disease (EAD). Unmanaged episodes of anxiety can be antecedents of maladaptive behaviors, including agitation, anger, and sometimes even violence.
SR is a dyadic strategy; both the person with EAD and the caregiver engaged the patient's memory to interrupt a current episode of anxiety.
详细描述
Through the intervention, family caregivers are trained to collaborate with and guide patients to access positive memories as a way to manage or move past the anxiety that plagues individuals with EAD - often arising when confronted by common complex tasks they previously were able to perform.
During the project's first six months (phase 1), the investigators will develop a series of 4 video-vignettes illustrating dyads (including one member with EAD) managing a variety of anxiety provoking scenarios associated with EAD (e.g., trouble reconciling a checkbook) through the use of SR.
During the second phase of the project, a research assistant will administer SR at four home visits. The SR intervention has three components:
- A didactic component using the SR manual that the couple retains (15 minutes);
- Viewing one of the brief video-vignettes illustrating the application of reminiscence techniques (5 minutes; a different video-vignette will be viewed at each visit; and
- Facilitation of caregiver practice in applying the techniques, using a recent example of anxiety-linked experience of the person with EAD (10 minutes). The caregiver is encouraged to learn and practice the techniques in order to cue and coach the person with EAD in their use.
The attention control treatment, a Social Visit, is a 30-minute activity in which the person with EAD, the caregiver and the research assistant (RA) review and discuss the day's newspaper headlines. The RA will use communication techniques specifically designed to keep the conversation present focused.
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
- •Live in the community
- •Reside with a primary caregiver who must be willing to participate in all study activities (the primary caregiver must have a familial or marital relationship with the person with EAD of sufficient length to support reminiscence activity [i.e., an adult child, a long-term spouse or committed partner])
- •Have received a diagnosis of Early Alzheimer's Disease from a primary care provider
- •Achieve a score on the mini-mental state examination (MMSE) between 19 and 25
排除标准
- •Unable to give consent
- •MMSE score lower than 19 or greater than 25.
结局指标
主要结局
Acceptability of SR and AC
时间窗: Week 20
Taped interview with the dyad will occur asking how acceptable the format, duration, and frequency of the program
次要结局
- Change in State-Trait Anxiety Inventory (STAI) scale(Baseline, week 20)
- Number of times AC was used(Week 20)
- Number of times SR was used(Week 20)
- Change in Beck Depression Inventory-II (BDI-II) scale(Baseline, week 20)
- Change in Katz Instrumental Activities of Daily Living (IADL) scale(Baseline, week 20)
- Change in Well-Being Picture Scale (WBPS) scale(Baseline, week 20)
- Change in Short Psychological Well-Being Scale (SPWBS) scale(Baseline, week 20)
- Change in Revised Memory and Behavior Problems Checklist (RMBPC) scale(Baseline, week 20)
- Caregiver's mastery of SR intervention technique(Week 20)
- Change in levels of cortisol(Baseline, Week 20)
研究者
William Puentes
Clinical Professor
Emory University