Life Enhancing Activities for Family Caregivers (LEAF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977)
研究概览
简要总结
Life Enhancing Activities for Family Caregivers is a six-week program designed to increase positive affect in people who care for a family member with dementia. The intervention consists of 6 weekly one-hour sessions conducted one-on-one with a trained facilitator to teach simple skills that are practiced at home in a study-supplied workbook. The program is preceded and followed by a 30-45 minute questionnaire. Follow-up assessments will be conducted at 1-month, 3-months, and 6-months post intervention.
Primary hypothesis is that experimental subjects who participate in LEAF will demonstrate significantly greater improvements in psychological outcomes and will engage in more problem focused and positive appraisal forms of coping compared to the wait-list control condition.
详细描述
All study activities can be conducted from the participant's home, making participation possible for any qualified caregiver with computer and wifi access, in any U.S. state. The LEAF study will supply the tablet computer, software, and workbook required for participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Participants must be able to be defined as the primary care provider for a family member with dementia. (Person with dementia must live with the caregiver or in their own home and not in a care facility.)
- •Must speak and read English
- •Must have the ability to provide informed consent
排除标准
- •Lack of access to a high speed internet connection
- •Evidence of severe cognitive impairment or active psychosis, as assessed by trained interviewers
研究组 & 干预措施
positive affect intervention
positive affect intervention
干预措施: Positive Affect (Behavioral)
wait list control
wait list control
结局指标
主要结局
Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977)
时间窗: Baseline and weeks 6 and 10; 3-months and 6-months post
The DES will be used to assess positive and negative affect. This 20-item version of the DES was modified to include additional positive affect items as well as those that are likely to tap into trait positive affectivity. The full scale assesses interest, enjoyment, surprise, sadness, anger, disgust, contempt, fear, guilt, shame, shyness, amusement, awe, contentment, gratitude, hope, love, pride, sympathy, and sexual feelings (e.g., "I felt sexual, desiring, and flirtatious"). The scale can be scored for total positive and negative affect,grouped according to where they would fall on the circumplex model of affect (e.g., high activation vs. lower activation),or individual affects can be examined. In student samples this modified DES has shown acceptable reliability with the positive affects subscale (α = .79) and the negative affects subscale (α = .69).
次要结局
- Change in perceived stress at end of intervention, 3 and 6-months post - Perceived Stress Scale (PSS) (Cohen, 1988)(Baseline and weeks 6 and 10; 3-months and 6-months post)
- Change in coping at end of intervention, 3 and 6-months post - Ways of Coping Scale (Folkman, Lazarus, Pimley, & Novacek, 1987)(Baseline and weeks 6 and 10; 3-months and 6-months post)
- Change in anxiety at end of intervention, 3 and 6-months post - Emotional Distress - Anxiety, PROMIS Item Bank v. 1.0 (Cella et al., 2010)(Baseline and weeks 6 and 10; 3-months and 6-months post)
- Change in burden at end of intervention, 3 and 6-months post - Zarit Burden Inventory (Zarit, Reever, & Bach-Peterson, 1980)(Baseline and weeks 6 and 10; 3-months and 6-months post)
- Change in depression at end of intervention, 3 and 6-months post - Depression, Patient Reported Outcomes Measurement Information System Item Bank, v. 1.0 (PROMIS; Cella et al., 2010)(Baseline and weeks 6 and 10; 3-months and 6-months post)
- Change in caregiver strain at end of intervention, 3 and 6-months post - Caregiver Strain Index (CSI) (Robinson, 1983)(Baseline and weeks 6 and 10; 3-months and 6-months post)
研究者
Glenna Dowling
Professor and chair, Department of Physiological Nursing
University of California, San Francisco