Demonstrating the Efficacy of "Unidos en el Cuidado" (United in Caring): A Spanish-Language Program for Latino Caregivers of Persons Living With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Depressive symptoms
研究概览
简要总结
The investigators will test the efficacy of Unidos en el Cuidado® (United in Caring, herein Unidos), a 3-session, culturally-adapted, group psychoeducational and skill-building intervention for 226 Spanish-speaking family caregivers in California.
详细描述
The investigators will test the efficacy of Unidos en el Cuidado® (United in Caring, herein Unidos), a 3-session, culturally-adapted, group psychoeducational and skill-building intervention for 226 Spanish-speaking family caregivers in California.
Based on a wait list trial design, and 4 observation points (baseline, post-intervention, 3-month and 6-month follow-ups), the investigators propose to demonstrate the efficacy of this new intervention (Aim 1), and evaluate for potential moderating conditions across subgroups (Aim 2; age, gender, educational level, etc.). Based on this quantitative component, the investigators will answer the following two aims:
Aim #1. (Efficacy) Compared to a waitlist control group, is Unidos efficacious with regards to primary outcomes-PHQ-9 depression symptoms, RMBPC reactivity to memory and behavior problems, anxiety symptoms, and secondary outcomes-caregiver mastery, competence, and meaning over time?
Aim #2: (Moderators). Do moderating conditions exist such that the intervention is more or less efficacious for subgroups based on age, gender, PLWD functioning?
Qualitative component: After class completion, the investigators will draw from 40-50 focus group participants to elucidate the satisfaction and acceptability of the program. Both Unidos and wait list control participants will be randomly selected for focus group interviews which will be guided by open-ended inquiries around the nuanced, in-depth perspectives of program participation, acceptability, and recommendations (Aim 3).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •identifies with being Hispanic or Latino descent
- •speaks and reads Spanish
- •dementia family caregivers living (or recently lived) in California or whose care recipient lives (or recently lived) in California
- •who identify as women, men, or non-binary,
- •age 18 years or older
排除标准
- •Severe sensory or physical conditions that interfere with ongoing participation.
研究组 & 干预措施
Group A: Treatment Group Receives the Classes Soon after Randomization
The Spanish-language caregiver classes are called Unidos en el Cuidado and are taught online by Alzheimer's Los Angeles. Sessions are provided at no cost and held weekly for about 2 hours.
干预措施: Skill-building classes (Other)
Group B: Wait List Control Group Receives the Classes after a Waiting Period
This wait list control group receives the same classes but after a 3-4 week waiting period.
干预措施: Wait list control group (Other)
结局指标
主要结局
Depressive symptoms
时间窗: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Patient Health Questionnaire 9 item standardized scale: min. to max values=0 to 27; higher values indicate worse outcomes
Presence and reaction to memory and behavior problems shown by person with dementia
时间窗: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Revised Memory and Behavior Problems Checklist standardized scale: 1. Symptom presence (yes/no); min. to max values=0 to 24; higher values indicate worse outcomes 2. Symptom reaction: Include only items with frequency scores of 1 to 4 in the reaction scoring. Compute the mean reaction score by summing reaction scores of these items and then dividing by the number of items included in the sum. the range for each subscale is 0 to 4. Higher values indicate worse outcomes
Anxiety symptoms
时间窗: baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline
Generalized Anxiety Disorder 7 item standardized scale: min. to max values=0 to 24; higher values indicate worse outcomes
次要结局
- Caregiver Mastery(baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline)
- Caregiver Competence(baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline)
- Caregiver Meaning(baseline; post-intervention (within 1 week of completing intervention); 3-months; 6-months from baseline)
研究者
Maria P. Aranda
Professor
University of Southern California