跳至主要内容
临床试验/NCT07370311
NCT07370311招募中不适用

A Culturally Adapted Decision Aid Intervention to Support Chinese American Dementia Caregivers in Feeding-Related Decisions

Yaolin Pei1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Yaolin Pei
入组人数
60
试验地点
1
主要终点
Decision conflict

研究概览

简要总结

Family caregivers of people with dementia have to decide between tube feeding and hand feeding when persistent eating problems arise. This decision can be difficult for Chinese American dementia caregivers, due to the interplay of culture, potential absence of a patient's advance directive, poor understanding of dementia, and lack of knowledge on the risks and benefits of tube feeding. In this polit study, the principal investigator examines whether a culturally adapted decision aid intervention regarding feeding options named "Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid" (CMCFODA) will improve Chinese American caregivers' decision-making about feeding options in patients with moderate or advanced dementia. The proposed study advances the field by providing critical evidence to inform the development and implementation of culturally adapted decision support interventions in end-of-life dementia care.

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
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 21 years and older
  • •Self-identify as Chinese
  • •Providing caregiving or involvement in end-of-life care decision-making for older Chinese adults with: a) moderate or advanced dementia, b) feeding difficulties, and c) poor oral intake, eating/swallowing problems, or weight loss

排除标准

  • •Dementia patients are a) receiving tube feeding, b) enrolled in hospice care, or 3) have a documented preference against a feeding tube

研究组 & 干预措施

Participation Group

No Intervention
  1. Receive usual care (including information from healthcare providers)
  2. Receive electrical version of decision aid after all of the data collection

Intervention/Treatment Group

Experimental
  1. Receive both the electronic and paper version of CMCFODA
  2. Receive an individualized decision coaching within two weeks

干预措施: Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid (Other)

结局指标

主要结局

Decision conflict

时间窗: Baseline; One-Month Follow-Up; Three-Month Follow-Up

SURE test for decisional conflict (0-4)

Knowledge of feeding options and dementia

时间窗: Baseline; One-Month Follow-Up; Three-Month Follow-Up

Questions to assess knowledge about feeding options and dementia

Expectations of tube feeding

时间窗: Baseline; One-Month Follow-Up; Three-Month Follow-Up

Questions about understanding differing expectations regarding feeding tube use

次要结局

  • The Feasibility of the CMCFODA study as measured by recruitment rates and the proportion of participants that decline participation.(Enrollment)
  • The Feasibility of the CMCFODA study as measured by participant retention, as indicated by the number of participants lost to follow-up.(Enrollment, One-Month Follow-Up,Three-Month Follow-Up)
  • Acceptability of the decision aid and decision coaching (only for the treatment group)(One Month Follow-Up)
  • Frequency of communication with other family members and healthcare providers(Baseline; One-Month Follow-Up; Three-Month Follow-Up)
  • Preference of feeding option(Baseline; One-Month Follow-Up; Three-Month Follow-Up)
  • Preparation for decision-making scale (treatment group only)(One-Month Follow-Up; Three-Month Follow-Up)

研究者

发起方
Yaolin Pei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yaolin Pei

PhD

University of Texas at Austin

研究点 (1)

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