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临床试验/NCT03033875
NCT03033875已完成不适用

Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers

Emory University2 个研究点 分布在 1 个国家目标入组 261 人开始时间: 2017年5月18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
261
试验地点
2
主要终点
State-Trait Anxiety Inventory (STAI) State Score

研究概览

简要总结

The purpose of this study is to test the psychoeducational program "Tele-Savvy." Tele-Savvy is an internet based, group education program developed from an in person program called Savvy Caregiver. Participants will be randomly assigned to either the Tele-Savvy group (receiving only the Tele-Savvy education) or the Healthy Living Education Program (receiving healthy lifestyle education and then Tele-Savvy education 6 months later) or a usual care group (receiving Tele-Savvy education 6 months later). Each program takes 43 days to complete.

详细描述

This study addresses the reliance on family members to provide virtually all community-based care for 5.3 million persons living with Alzheimer's disease and other dementias, a population that will likely triple in the next 35 years. Unless researchers soon find a way to prevent and cure dementing illnesses like Alzheimer's, the country will continue to face an urgent need to find ways to sustain and bolster the capacity of these family caregivers to manage the multiple daily care challenges they face and to preserve their well-being while doing so. Without family caregivers, the burden of care could well overwhelm the formal components of our care system. A number of psychoeducation programs for caregivers have been effective in relieving distress, increasing self-efficacy, managing caregiving challenges, and enabling caregivers to sustain care over longer periods of time. However, many Alzheimer's caregivers cannot take part in these programs because virtually all such programs require caregivers to arrange care for the care recipient while the caregivers attend the programs. These are obstacles in rural or remote areas where transportation issues further restrict caregivers' already limited access to caregiver programs, but they are no less a problem in inner cities and suburbs. These obstacles highlight a substantial challenge to our ability to rely on caregivers as a continuing care resource for persons living with Alzheimer's disease: there is a need for theory-driven psychoeducation programs that can be made readily available to caregivers who may not be able to attend in-person programs.

This is a randomized trial to test a program designed to meet this critical need. This study will test Tele-Savvy, an internet-based program based on the widely disseminated, in-person Savvy Caregiver psychoeducation program. Delivered in scheduled videoconferences and independently viewed on-line video lessons, Tele-Savvy aims to develop/enhance caregivers' skills and caregiving mastery, reduce adverse effects of caregiving, and improve the quality of the lives of caregivers and care recipients.

Caregivers will be randomly assigned either to immediate Tele-Savvy participation groups or to attention control or usual care groups that are invited to participate in Tele-Savvy six months after baseline data collection. Each program takes 43 days to complete. In those 43 days, participants will be asked to take part in a video conference once per week (60-90 minutes) and view daily video lessons (7-15 minutes). The study includes 5 interviews over the course of the 12 month study; the interviews at baseline and months 3 and 6 assess the study outcome measures. These interviews will discuss participant's experience as a caregiver. All interviews will be limited to 60 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Informal caregivers (family/friends) of persons living with Alzheimer's disease or another dementia
  • Participants must be providing at least 4 hours per day unpaid assistance, on average, for a person in the early-middle stage of illness (Clinical Dementia Rating of greater than or equal to 1 by home ADC) who is community-dwelling and for whom there is no established plan for institutionalization in the next six months
  • Caregiver may or may not reside with their care recipient, but care recipients must live in the community and not in an assisted living facility, nursing home, or another institutional setting
  • Must have access to a computer or a mobile device with adequate internet connection, microphone, and speakers (to be able to participate in teleconferences) and be able to use email
  • Able to read, speak and understand English

排除标准

  • The participant must not be involved in another caregiver training study and must not have participated in in-person Savvy Caregiver Program or Tele-Savvy previously
  • Uncorrectable vision or hearing deficits that might impede participation

结局指标

主要结局

State-Trait Anxiety Inventory (STAI) State Score

时间窗: Baseline, Month 3, Month 6

The STAI State (STAI-S) is a 20-item 4-point Likert scale commonly used measure of state anxiety. Respondents report the intensity of their anxiety at that moment on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.

Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score

时间窗: Baseline, Month 3, Month 6

The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Zarit Burden Inventory (ZBI) Score

时间窗: Baseline, Month 3, Month 6

The ZBI is a 22 item scale. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total scores range from 0 (low burden) to 88 (high burden)

次要结局

  • Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score(Baseline, Month 3, Month 6)
  • Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score(Baseline, Month 3, Month 6)
  • Perceived Stress Scale (PSS) Score(Baseline, Month 3, Month 6)
  • Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score(Baseline, Month 3, Month 6)

研究者

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

Kenneth Hepburn

Professor

Emory University

研究点 (2)

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