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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

AdventHealth1 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
干预措施

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
1
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
是

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

研究组 & 干预措施

Intervention

Experimental

Performing arts instruction delivered 1 hour/week for 8 weeks.

干预措施: Performing Arts Instruction (Behavioral)

Wait List Control

No Intervention

Control group. Performing arts instruction delivered upon completion of control period.

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 (1)

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