跳至主要内容
临床试验/NCT04350060
NCT04350060已完成不适用

Memory Care of the Future: Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年2月2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
Mayo Clinic
入组人数
10
试验地点
2
主要终点
Change in function and independence, as measured by the Katz Index of Independence in Activities of Daily living (KATZ)

研究概览

简要总结

Research study is being done to demonstrate novel opportunities to transform the way the dementia community is cared for.

研究设计

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

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients currently residing at Arbor Terrace memory care unit
  • Patients diagnosed with dementia

排除标准

  • Hospice patients with less than 30 days of life expectancy at the time of enrollment

结局指标

主要结局

Change in function and independence, as measured by the Katz Index of Independence in Activities of Daily living (KATZ)

时间窗: every 2 weeks for up to one year

Measured using the self-reported KATZ questionnaire with a scale of independence = 1 and dependence = 0 to determine total score. The KATZ ranges from 0 to 6 with the lower score indicated patient is very dependent and the higher score indicated patient is independent.

Change in quality of life, as measured by the Quality of Life in Alzheimer's disease (QOL-AD)

时间窗: every 2 weeks for up to one year

Measured using the self-reported QOL-AD questionnaire comprised of 13 questions with a scale of poor = 1, fair = 2, good = 3, excellent =4. Scores range from 13 to 52, with higher scored indicating better quality of life.

Change in sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI)

时间窗: every 2 weeks for up to one year

Measured using the self-reported PSQI that uses 9 questions regarding sleep quality to determine a final score where a total of "5" or greater is indicative of poor sleep quality.

Change in dementia related behaviors and delirium, as measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q)

时间窗: every 2 weeks for up to one year

Measured using the self-reported NPI-Q questionnaire that reports Yes = present or No = absent on 12 domains. If yes, then the informant rates the severity of the symptoms on a 3-point scale (1 = mild, 2 = moderate, 3 = severe) and the distress of the symptoms on a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme or very severe).

Change in mood, as measured by the Patient Health Questionnaire 9 (PHQ-9)

时间窗: every 2 weeks for up to one year

Measured using the self-reported PHQ-9 questionnaire that uses 9 question regarding patient health with a sale of not at all = 0, several days = 1, more than half the days = 2, nearly everyday =3. Scores range from 0 to 27, with higher scored indicating grater severity of depression.

Change in medication use

时间窗: every 2 weeks for up to one year

Measured using recorded medication use from patient's chart.

Change in falls

时间窗: monthly for up to one year

Measured using recorded fall data from patient's chart.

次要结局

  • Change in caregiver burden, as measured by the Caregiver Strain Index (CSI)(6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ying Ying (Christina) Chen

Principal Investigator

Mayo Clinic

研究点 (2)

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