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临床试验/NCT03550131
NCT03550131已完成不适用

Aging With Pride: Innovations in Dementia Empowerment and Action

University of Washington2 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2018年12月5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
322
试验地点
2
主要终点
Change in Physical Activity of Care Recipient

研究概览

简要总结

The lack of efficacious research-based interventions for such vulnerable older adults with Alzheimer's disease and related dementias (AD/RD) and their caregivers (CGs) is a significant public health problem. Caregiving of sexual/gender minority older adults with AD/RD is of concern due to social stigma, marginalization, and isolation, which may be barriers to sustaining caregiving. It is necessary and timely to translate evidence-based culturally adaptable interventions for this underserved and stigmatized population. Reducing Disability in Alzheimer's Disease (RDAD) has been evaluated in a randomized controlled trial and has shown to successfully train community-dwelling CR (care receiver)-CG dyads to increase the physical activity and functioning of individuals with AD/RD and their CGs and to teach CGs techniques for managing behavioral symptoms of CRs. RDAD consequently decreases stress of CGs, delays institutionalization of CRs, and increases health related quality of life (HRQOL) of CRs and CGs. Thus, this study will evaluate the effect of the standard RDAD among lesbian, gay, bisexual, and transgender (LGBT) CRs with AD/RD and their CGs, and this study will test a personalized intervention tailored to better respond to distinct risks experienced by CGs and LGBT CRs with AD/RD, addressing unique sexual/gender minority CG risk factors (e.g., identity management, stigma-related adverse or traumatic life events, and lack of social support).

详细描述

We will address the following aims:

Aim 1. Test the translation and enhancement of intervention designed to increase physical activities of older adult care receivers (CRs) with AD/RD and their CGs. Aim 2. Evaluate the short- and long-term effect of the standard and personalized intervention on primary (physical activity and functioning; perceived stress for CGs; independence/residential status (institutionalization) for CRs) and secondary outcomes (HRQOL; depressive symptomatology; behavioral disturbances for CRs). Aim 3. Test the moderating roles of CR-CG characteristics, including type of CR-CG relationship, sex, and severity of CR AD/RD, on the treatment effect of the standard and personalized intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants receiving intervention will not be informed whether it is the standard or personalized treatment.

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Physical Activity of Care Recipient

时间窗: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

Measured by the days of aerobic activity for at least 30 minutes in the past week with higher numbers indicating more days of activity.

次要结局

  • Memory-Related Disturbance, Care Recipient(Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months)
  • Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)(Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months)
  • Quality of Life in Alzheimer's Disease, Care Recipient(Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months)
  • Perceived Stress of Care Partner(Baseline, 6 weeks (Pre-treatment), 13 weeks (Post-treatment), 30 weeks, 13 months)
  • Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)(Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months)

研究者

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

Karen Fredriksen Goldsen

Professor

University of Washington

研究点 (2)

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