Early-Stage Partner in Care-Living Alone (EPIC-LA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Quality of Life in Alzheimer's Disease (QoL-AD)
研究概览
简要总结
EPICLA+ (Early-Stage Partners in Care Living Alone Plus) is a research project designed to assist people with early-stage memory loss who live alone in the community by providing early-stage related education and skill-training sessions, held via Zoom, designed to reduce stress, enhance well-being, manage challenges, and plan for the future. Researchers will gather feedback from individuals about their experience to continue to improve programs for early-stage memory loss.
详细描述
This study aims to create a supportive environment to help individuals with early-stage memory loss or early-stage dementia living alone in the community by providing education and skill-training programs, held via Zoom, where they can be educated in memory changes associated with dementia, learn to manage behavioral changes, improve communication skills, cope with stress, and plan for the future. About 70 people will be enrolled across the United States through Arizona State University.
People who decide to participate in this program voluntarily will be asked to:
Meet others in the earlier stages of memory loss who live alone Attend six group sessions via Zoom (2 hours and 30 minutes each) to learn strategies for handling new situations, reducing stress, improving mood, communicating better with others, and planning for the future.
Participate in one 90-minute individualized session via Zoom to address specific issues unique to each one's situation.
Participate in three 45-minute confidential interviews that involve questions about background, mood, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early-stage inclusion criteria
- •Must be at least 60 years of age
- •Must be able to participate in English or Spanish
- •Must be a US resident
- •Must be able to provide consent verbally and in writing (electronically or via mail)
- •Must exhibit at least 2 of 8 changes caused by thinking and memory problems on the AD8 (a reliable and valid 8-item dementia screening tool).
- •The Early-stage individual must have a diagnosis of early-stage ADRD or have a Mini-Mental State Exam (MMSE) score:
- •between 20-26 for those who have completed high school, or
- •between 17-26*, for those who have not completed high school, or
- •27 or higher with a confirmed diagnosis of early-stage dementia or MCI.
- •Able to participate in EPIC-LA workshops via zoom
排除标准
- •Inability to participate via telephone or online video conferencing service.
- •The participant expresses feelings of not wanting to participate
- •The participant do not have enough time to attend the training,
- •The participant demonstrates lack of skills with using a computer that precludes participation
- •The participant does not have a stable internet connection to connect to the video platform
- •The participant has difficulty hearing or a visual impairment that precludes participation.
研究组 & 干预措施
EPICLA+
Group EPICLA+ will start the intervention immediately after assessment 1. The EPICLA+ program consists of a 7-session, psychoeducational skills training intervention, held via Zoom, designed to assist people with early-stage memory loss that live alone in the community by providing early-stage-related education and skill-training sessions to reduce stress, enhance well-being, manage challenges, and plan for the future. Following the 7 EPIC sessions, participants will attend a booster session, held via Zoom, to reinforce the skills/lessons.
干预措施: Psychoeducational skills training intervention (Behavioral)
Wait List Control (WLC)
The WLC group will start the intervention after 3 months of the EPICLA+ group start date, once T2 assessment is completed.
干预措施: Psychoeducational skills training intervention (Behavioral)
结局指标
主要结局
Quality of Life in Alzheimer's Disease (QoL-AD)
时间窗: Baseline, at 3 months, and at 6 months
This scale assesses 13 global items of quality of life covering areas like physical health, mood, family, and finances, with the outcomes poor, fair, good, and excellent. It can be used across different dementia stages and is designed for individuals with dementia and their caregivers. The scale consists of 13 questions. Each question has four possible responses - poor, fair, good, and excellent, each equating to 1-4 points respectively. The total score ranges from 13 to 52, with higher scores indicating a higher quality of life.
UCLA 3-item Loneliness Scale
时间窗: Baseline, at 3 months, and at 6 months
This scale comprises three questions that measure three dimensions of loneliness: relational connectedness, social connectedness, and self-perceived isolation. The scale is rated with hardly ever, some of the time, and often, with scores ranging from 1 to 3, respectively. The total score ranges from 3 to 9, with scores ranging from 6 to 9 indicating loneliness.
Dementia Quality of Life (DQoL)- Positive and Negative Feelings Affect Scale
时间窗: Baseline, at 3 months, and at 6 months
The DQoL consists of 30 items and five scales: positive affect (six items), negative affect (11 items), feelings of belonging (three items), self-esteem (four items), sense of aesthetics (five items) and one global item. QDOL is a Likert scale with the outcomes never, seldom, sometimes, often, and very often, ranging from 1 to 5, respectively. Higher scores indicate better QoL, except on the negative affect scale. The study focuses on assessing positive (e.g., content) and negative (e.g., afraid) feelings.
Center of Epidemiologic Studies-Depression short form (CES-D)
时间窗: Baseline, at 3 months, and at 6 months
Shortened version of the CESD-20. It measures depressive symptoms and assesses feelings such as feeling bothered by things, having trouble concentrating, etc. It is scored by summing the responses to its 10 items, each rated on a 4-point scale with scores rarely or none of the time, some of the time, occasionally, and most of the time, ranging from 0 to 3, respectively. Total scores range from 0 to 30, with higher scores indicating greater depressive symptoms.
Hopkins Symptoms Checklist - Anger Subscale
时间窗: Baseline, at 3 months, and at 6 months
Tool used for assessing feelings, such as feeling critical of others, irritated, tense, calm, etc., using the Likert scale not at all, a little, somewhat, and very much with scores ranging from 0 to 3 respectively. higher scores indicate higher levels of anger.
次要结局
- Care Preparedness Scale(Baseline, at 3 months, and at 6 months)
- Leisure Satisfaction Scale(Baseline, at 3 months, and at 6 months)
- Knowledge of Dementia (modified)(Baseline, at 3 months, and at 6 months)
- Care preferences/circle diagrams(Baseline, at 3 months, and at 6 months)
- Decision-making in daily and long-term care(Baseline, at 3 months, and at 6 months)
- Emotional-Intimacy Disruptive Behavior Scale(Baseline, at 3 months, and at 6 months)
- Dementia Quality of life Instrument- self-esteem subscale(Baseline, at 3 months, and at 6 months)
研究者
Abigail Gomez Morales
Assistant Professor
Arizona State University