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临床试验/NCT04421729
NCT04421729已完成不适用

SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in

University of Southern California2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2020年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
2
主要终点
Revised Memory and Behavior Problems Checklist (RMBPC)

研究概览

简要总结

The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months.

详细描述

A number of epidemiological studies, systematic reviews, and consensus reports highlight the importance of non-pharmacological, sociobehavioural interventions to address the health, psychological, and social effects of caregiving for persons living with dementia, and the need for tangible information and resources.

The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months. It is hypothesized that no differences (comparable effects) between the programs in their efficacy/effectiveness and moderating conditions.

Focus groups (~25 participants) will be conducted to ascertain program acceptability and satisfaction.

The analyses will include a multiple linear mixed-effects modeling for our trial outcomes, and thematic analyses for our focus group interview data.

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
Single (Outcomes Assessor)

盲法说明

The outcome assessor will not have previous knowledge of the respondent's interventional group assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English- speaking women and men age 18 or older who care for or provide assistance to someone with dementia

排除标准

  • Caregivers who have sensory or physical conditions that interfere with participation in an on-site, group-administered activity

结局指标

主要结局

Revised Memory and Behavior Problems Checklist (RMBPC)

时间窗: up to 7 months

caregiver reactivity to family member's memory/behavior problems

Patient Health Questionnaire-9 (PHQ-9)

时间窗: up to 7 months

caregiver depressive symptoms

Generalized Anxiety Disorder (GAD-7)

时间窗: up to 7 months

caregiver anxiety symptoms

次要结局

  • Medical Outcomes Study Social Support Survey (MOS)(up to 7 months)
  • Intent to Institutionalize(up to 7 months)
  • Caregiver Competence Scales(up to 7 months)
  • Family Members Activities of Daily Living (ADL)(up to 7 months)
  • Family Members Instrumental Activities of Daily Living (IADL)(up to 7 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria P. Aranda

Associate Professor

University of Southern California

研究点 (2)

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