Providing Support to Caregivers of Frail Older Adults With Cognitive Impairments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in depression change measured by the Center for Epidemiology Studies-Depression
研究概览
简要总结
This randomized control study is to test effectiveness of occupational therapy support for informal caregivers of older adults with cognitive decline. Care recipients are community-living older adults who are eligible for a nursing home level of care. At baseline challenges that caregivers are facing will be expressed and individualized solutions will be identified and delivered for the treatment and educational material will be given to the control group. Two and four months later, follow up interview will be made to identify changes in burden, depression, fatigue, self-efficacy, and positive aspect of care giving. It is expected to show when the effectiveness becomes clear.
详细描述
Family caregivers of frail older adults with cognitive impairments face special challenges in caring for their care recipients (CR) due to their fast declining health. Examples of difficulties include managing CR's behaviors and daily activities, as well as maintaining their own psychological and physical health, which result in high caregiver burden. The aim is to support these caregivers of older adults who are enrollees of the Program for All-inclusive Care for the Elderly (PACE) through occupational therapy (OT) interventions to reduce caregiver burden and depression, and increase positive aspects of caregiving and self-efficacy. Since PACE organizations offer limited support for caregivers due to understanding, supervised OT graduate students (OTGS) will provide caregivers with customized supports. By doing so, the students will gain precious experience before they enter the workforce. This proposal will develop and test the effectiveness of this collaborative model. This study will use a randomized controlled design with about a 4- month intervention period. The assessments will take place at baseline, 2 months and 4 months. The study period will be two years. Participants will be 60 convenience family caregivers of the PACE enrollees in Western New York; therefore, CRs are 55 years old or older, need a nursing home level of care, but remain living in the community. Caregivers are adults who visit the CR at least once a week. OTGS will contact the caregivers, using a phone, and conduct an in depth interview to understand their difficulties. Then solutions will be brainstormed amongst OTs and geriatric specialists, and interventions will be formed. At the first visit to the CRs' homes, interviews will be conducted using the Zarit Burden Interview, the Center for Epidemiology Study for Depression, the Buffalo Fatigue Scale, the Positive Aspect of Caregiving, and the Visual Analogue Scale for self-efficacy. The possible solutions will be discussed with caregivers and more detailed difficulties will be videotaped. The solutions that caregivers are comfortable with will be reviewed by the PACE Rehabilitation Department and need to be approved before their implementation. The solutions may include: education of disease process, training for caregivers in supporting CR's activities of daily living (ADL) and instrumental ADL, coordination of family caregivers, problematic behaviors, functional exercise, fall prevention, and increased number of CR's visits to a PACE daycare facility. Statistical analysis will use Generalized Estimating Equations to compare the two groups' linear trends. We expect CRs' condition will deteriorate but the treatment group will reduce caregiver burden and increase self-efficacy.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Caregivers of community-dwelling older adults (55 and over) who are member of the PACE
- •Adult 21 years or older
- •Living with the care recipient or within a distance so that they can visit him/her minimum once a week
- •Cognitively intact (can recall three words immediately and 3 minutes later)
- •Competent in English
排除标准
- •One instrument (Positive aspect of caregiving) is only available in English. To fully understand caregivers' challenges and convey solutions, our current study OT graduate students are not competent enough in other languages to provide interventions. We do not have budget to hire interpreters.
结局指标
主要结局
Change in depression change measured by the Center for Epidemiology Studies-Depression
时间窗: 4 months
To measure changes in depression using the Center for Epidemiology Studies -Depression (CES-D). This scale asks how often a respondent experienced symptoms associated with depression within the past week. The scale is scored from 0 to 3, with 0 representing rarely or none of the time (less than one day), 1 representing some or a little of the time (1 to 2 days), 2 representing occasionally or a moderate amount of time (3 to 4 days), or 3 representing most or all of the time (5 to 7 days). Total scores could range from 0 (the lowest depression score) to 60 (the highest). A score of 16 or higher indicates a depressive symptom. The CES-D has high internal consistency (Cronbach's alpha =.90) (Cosco et al., 2017), and moderate test-retest reliability (the strongest occurring whiten one to three weeks of time), as well as good measurement validity (Gonzalez et al, 2016).
Change in caregiver burden measured by the Zarit Burden Interview
时间窗: 4 months
To measure changes in burden of care using the 22-item Zarit Burden Interview (ZBI). Each item is rated from Never (0), Rarely (1), Sometimes (2), Quite Frequently (3), to Nearly Always (4). Higher scores indicate higher burden. The ZBI is scored by adding up the responses of all items, ranging from 0 to 88. The interpretations of scores are: 0-20 (no burden), 21-40 (mild to moderate burden), 41-60 (moderate to severe burden), and 61-88 (severe burden). The ZBI has good internal consistency reliability and good validity, and scores were significantly positively correlated with behavior problems in the care recipients and depression scores of the caregivers, according to the study using caregivers (Herbert et al, 2000).
Change in confidence to continue caring for the care recipient in the future (6 months)
时间窗: 4 months
To measure changes in confidence to confine caring for the care recipient using Visual Analogue Scale. It asks caregivers to rate their confidence on a scale of 1 to 10 on Visual Analogue Scale. This assessment asked the caregivers to rate themselves regarding their confidence in in caring for the care recipient in six months. A score of 1 represents no confidence, 5, mid-level confidence, and 10 represents completely confidence.
次要结局
- Change in a cognitive level of care recipients measured by the Global Deterioration Scale(4 months)
- Change in instrumental activities of daily living (IADL) of care recipients measured by IADL from the Older Americans Resources and Services(4 months)
研究者
Machiko R Tomita
Clinical Professor
State University of New York at Buffalo