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临床试验/NCT03734289
NCT03734289已完成不适用

Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With Alzheimer Dementia and Traumatic Brain Injury (NeuroNS) Study

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2017年2月1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
88
试验地点
2
主要终点
Change in Zarit Burden Interview

研究概览

简要总结

To reduce care resistant behaviors (CRB) among people with dementia residing in nursing homes, to a distance-learning education, training, and coaching program for family caregivers of people with dementia or TBI; assess the efficacy of the intervention for reducing frequency or severity of CRB-triggered symptoms of agitation, aggression, and irritability; assess the efficacy of the intervention for improving quality of life of patients, caregivers, and families; and determine how patient and caregiver characteristics influence the effectiveness of the intervention.

5. Evaluate how the intervention affects the health care costs of people with dementia or TBI.

详细描述

To address the previously unanswered question of whether theoretically-driven caregiver education and coaching in nonpharmacologic approaches to reduce care resistant behaviors as a trigger of behavioral and psychiatric symptoms of dementia (BPSD) and neuropsychiatric symptoms after Traumatic Brain Injury (NPTBI) will improve caregiver burden, quality of life (QOL), and related outcomes of patients with these conditions and their family members. The intervention of interest is the Neurobehavioral Non-Pharmacologic Supportive Strategies for Family Caregivers of Persons with Dementia or TBI (NeuroNS-Care). Behavioral symptoms in dementia and following TBI vary considerably over time, with a tendency toward spontaneous regression to the mean. Additionally, caregivers often develop idiosyncratic strategies in response to adverse behaviors that might be either adaptive or maladaptive. In order to separate the effects of time alone from the effects of the coaching intervention, one group will be randomized to delayed intervention following a 6 week wait time. This will allow the investigative team the opportunity to compare the natural history of the outcome variables in an "untrained" portion of the sample to the effects of training over a similar time period.

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 —(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 Zarit Burden Interview

时间窗: Change from baseline to 6-month follow-up

A measure of caregiver burden

次要结局

  • Change in Connor-Davidson Resilience Scale (CD-RISC)(Change from baseline through 6-month follow-up)
  • Change in Family Quality of Life (Dementia or TBI versions)(Change from baseline through 6-month follow-up)
  • Change in Neuropsychiatric Inventory(Change from baseline through 6-month follow-up)
  • Change in Dementia Quality of Life (DEMQOL/DEMQOL proxy)(Change from baseline through 6-month follow-up)

研究者

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

David Geldmacher

Professor

University of Alabama at Birmingham

研究点 (2)

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