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临床试验/NCT03653871
NCT03653871已完成不适用

The Effect of a Performing Arts Intervention on People With Dementia and Their Caregivers

AdventHealth2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AdventHealth
入组人数
75
试验地点
2
主要终点
Change caregiver burden as measured by Zarit Burden Interview

研究概览

简要总结

This study will examine whether a performing arts class will improve the well-being of primary unpaid caregivers of people with dementia

详细描述

This study used sample size analysis to determine the adequately sized intervention group and control group, well-defined statistical methodology, and a well-documented intervention that can be easily replicated. The intervention has been developed by Dr. Phillips Center for the Performing Arts leadership with assistance from AMS Planning & Research.

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 115 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary, unpaid caregiver of person with dementia OR
  • Person with Dementia.
  • Live independently in the community.
  • Care recipient has a Functional Assessment Staging Test (FAST) Score of 4-6b.
  • Caregiver does not display symptoms of emotional, cognitive, or mental impairment.
  • Caregiver must be able to produce adequate saliva sample.
  • Caregiver/care recipient can travel to program.
  • Caregiver/care recipient agree to participate in all aspects of study intervention and assessments.
  • Caregiver is 18 years of age or older.
  • Care recipient is 65 years of age or older
  • Access to home phone or mobile phone

排除标准

  • Unable to understand either spoken and/or written English.
  • Caregiver is a paid employee of care recipient's legally appointed representative

结局指标

主要结局

Change caregiver burden as measured by Zarit Burden Interview

时间窗: Baseline to 22 weeks

Zarit Burden Interview is a caregiver self-report measure. The Interview uses a 5 point Likert Scale (Never - 0, Rarely - 1, Sometimes - 2, Quite Frequently - 3, Nearly Always - 4). Score can range from 0- to 88. 0-21 - little or no burden, 21-40 mild to moderate burden, 41-60 moderate to severe burden, 61-88 severe burden. A lower score represents a better outcome.

Change caregiver resiliency as measured by Brief Resiliency Scale

时间窗: Baseline to 22 weeks

Brief Resilience Scale is a self report of items using a 5 point Likert Scale. Three of the items, the scale is as follows: (Strongly Disagree-1, Strongly Agree -5) For the remaining 3 items, the scale is reversed (Strongly Agree - 5, Strongly Agree 1) Score can range from 6-30 and is divided by 6. A higher score represents a better outcome.

次要结局

  • Determine if intervention helps recovery from agitation and disruptive behavior for caregivers as measured by salivary cortisol levels(Baseline to week 10)
  • Determine if intervention improves caregiver's perception of care recipient's quality of life as measured by Quality of Life - Alzheimer's Disease(Baseline to 22 weeks)

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (2)

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