跳至主要内容
临床试验/NCT02207803
NCT02207803已完成不适用

A Culturally Sensitive Intervention for TBI Caregivers in Latin America

Virginia Commonwealth University6 个研究点 分布在 2 个国家目标入组 250 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
6
主要终点
Zarit Burden Interview

研究概览

简要总结

Traumatic brain injury (TBI) patients in Latin America experience high levels of disability and extremely poor functional outcomes, and their informal caregivers play a key role in their rehabilitation and care. To improve TBI rehabilitation through stronger informal caregiving, the proposed study will develop and evaluate an evidence--based and culturally sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin America during the patient's transition from hospital to home. This study will generate findings that can provide empirically supported guidance to clinicians regarding the provision of culturally tailored rehabilitation services for TBI caregivers in Latin America and in the U.S.

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
Single (Care Provider)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Will be discharged home and not to a nursing home
  • Give permission for their caregiver to participate
  • Sign an informed consent
  • Have the ability to communicate over the phone for data collection
  • Are between 18-60 years of age
  • Caregiver Inclusion Criteria
  • Have a telephone in the home or cellular phone and are able to talk on the phone
  • Sign an informed consent
  • Score at least a 13 on a health literacy screening tool
  • Are between 18-85 years of age

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

Experimental Transition Assistance Program

干预措施: Transition Assistance Program (Behavioral)

Control

No Intervention

Control

结局指标

主要结局

Zarit Burden Interview

时间窗: 2 months post-hospital discharge

22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.

次要结局

  • Exemplary Care Scale-Provide Subscale(2 months post-hospital discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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