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临床试验/NCT04854564
NCT04854564已完成不适用

Identifying Perceived Barriers and Facilitators to Inform the Development of a Liver Transplantation Prehabilitation Intervention

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2021年8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
114
试验地点
1
主要终点
Liver frailty index (LFI) score

研究概览

简要总结

The purpose of this study is to formally identify patient and caregiver perceived needs, barriers, and facilitators to inform the development of a home-based multimodal prehabilitation program for potential LT candidates.

详细描述

After being informed about the study and potential risks, all participants (patients and caregivers) giving written informed consent will be invited to participate in one of three research activities: interviews (n=10), nominal group technique meetings (n=64), or card-sorting and rating survey (n=40).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
19 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Liver transplant (LT) candidates are:
  • Adult ESLD patients (age=19-74 years) who are assigned to the LT waitlist
  • English-speaking
  • No contraindication to moderate intensity physical activities
  • Physician clearance for participation in moderate intensity physical activities
  • No history of dementia or organic brain syndrome
  • Caregivers:
  • Adult (age≥ 19 years)
  • English-speaking
  • Provide direct care to LT candidates

排除标准

  • Inability to communicate verbally in English
  • Documentation of cognitive deficits

结局指标

主要结局

Liver frailty index (LFI) score

时间窗: From baseline through 3 months

Change from baseline in liver frailty index score at 3 months; the higher LFI scores indicate a higher degree of frailty. LFI\<3.2: robust, LFI=3.2-4.4: prefrail, LFI\>=4.5: Frail.

Caregiver burden measured using Zarit Burden Interview short form (ZBI-12)

时间窗: From baseline through 3 months

Change from baseline in the total ZBI-12 scores at 3 months. The total ZBI-12 score is the summation of 12 items, ranging from 0 to 48; the higher scores indicate higher burden (0-10:no to mild burden; 10-20: mild to moderate burden), and \>20: high burden.

次要结局

未报告次要终点

研究者

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

Haiyan Qu

Associate Professor

University of Alabama at Birmingham

研究点 (1)

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