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临床试验/NCT00388544
NCT00388544已完成2 期

A Prescription for Enhancing Resident Quality of Life

Penn State University2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2005年5月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
128
试验地点
2
主要终点
Agitation

研究概览

简要总结

Many persons with dementia exhibit behaviors that caregivers find difficult to manage. The purpose of this study is to test the effectiveness of individualized recreational activities for reducing agitation and passivity in persons with dementia.

详细描述

Most persons with dementia exhibit behavioral symptoms, such as agitation and passivity, at some time in the course of their illness. These behaviors are a source of caregiver burden and often precipitate nursing home placement. There are a number of drugs that can be used to treat these behaviors, but they are costly and have serious adverse effects in a sizable number of people. Non-drug interventions, such as recreational activities, are recommended as the first line of treatment for behavioral symptoms. However, we don't know which activities are most effective for individual residents. The "one size fits all" approach has not been very effective. We are testing an approach that individualizes activities for residents based on their personality style of interest and functional level. We anticipate that this approach will be more effective for reducing behavioral symptoms than routine activities given to all residents. Consenting residents are assessed for personality and functional level and are videotaped during a baseline period and during activities so we can reliably measure behaviors, affect and engagement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • English speaking; diagnosis of dementia; a willing informant who knows the subject well and who can provide past personality and other data; a stable dose of any psychoactive drug from pre-baseline through final observation; and presence of agitation or passivity.

排除标准

  • delirium or an unstable medical condition; history of Parkinson's disease, Huntington's disease, seizure disorder, stroke, alcoholism, drug abuse, head trauma with loss of consciousness, or psychiatric illness preceding the onset of memory loss; severe vision or hearing impairment; and receiving a new psychoactive medication within the past 30 days.

结局指标

主要结局

Agitation

时间窗: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

Passivity

时间窗: During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period

次要结局

  • Mood(During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
  • Affect(During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)
  • Engagement(During activity intervention, random times outside of activity intervention (during the intervention period), and one week post intervention period)

研究者

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

Ann Kolanowski

Professor of Nursing

Penn State University

研究点 (2)

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