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临床试验/NCT07280650
NCT07280650尚未招募不适用

Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study

University of Michigan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Feasibility and Acceptability as measured by the Feasibility Questionnaire

研究概览

简要总结

This study evaluates the feasibility and acceptability of using the artificial intelligence (AI) chatbot mobile application (an LLM-based Chatbot) to support the well-being of informal care partners of individuals with traumatic brain injury (TBI), dementia, or Huntington disease (HD). Over an 8-week intervention period, up to 60 care partners will engage with the application (app), spending four weeks focusing on physical health and four weeks focusing on mental health. Participants will complete surveys at the midpoint and end of the intervention period. Participants will also complete a semi-structured interview to discuss participants experience using an LLM-based Chatbot.

The study team hypothesizes that care partners will find the chatbot acceptable and feasible to use in daily life, and that there will be low attrition and high completion rates of the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

  • (care partner)
  • Age 18 years or older
  • Able to independently provide informed consent
  • Able to read, speak, and understand English
  • Have an Apple (iOS) smartphone, tablet, or laptop, have access to the internet and text messages, and be willing to use these resources for the study, including downloading and using the AI chatbot app (Earkick)
  • Be caring for and adult with a medically documented diagnosis of TBI, dementia or Huntington disease (HD)
  • Provide emotional, physical, and/or financial support/assistance to the individual with the TBI, dementia, or HD, indicating a response per protocol
  • Indicate high levels of caregiver burden, confirmed using the 12-item Zarit Burden questionnaire (scores must be ≥20)
  • Willing to complete all study assessments for the duration of their study participation
  • Inclusion Criteria (care recipient):
  • Age 18 years or older
  • Have a medically documented diagnosis of TBI, dementia or Huntington disease as noted per protocol

排除标准

  • (care partner)
  • Anyone not meeting inclusion criteria above
  • Professional, paid caregivers
  • Anyone at the discretion of the Principal investigator (PI) that would be a preclusion of safe or meaningful participation
  • Exclusion Criteria (care recipient):
  • Anyone not meeting inclusion criteria
  • Lives in a care facility (assisted living, nursing home) or is bedbound

研究组 & 干预措施

Earkick app

Experimental

干预措施: LLM-based Chatbot (Other)

结局指标

主要结局

Feasibility and Acceptability as measured by the Feasibility Questionnaire

时间窗: 8 weeks (post intervention)

Feasibility Questionnaire (items are scaled from 1 to 5 to indicate level of agreement, where "1" indicates "strong disagreement" and "5" indicates "strong agreement"). Feasibility and Acceptability as measured by ≥80% of participants indicating that care partners either "Agree" or "Strongly Agree" that the different study elements are feasible and acceptable.

次要结局

  • Attrition as measured by the percent of participants completing the study(Baseline to post intervention interview (approximately 8-12 weeks))
  • Adherence as measured by the percentage of missing data over the course of the study(Baseline to 8 weeks)

研究者

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

Noelle E Carlozzi

Professor

University of Michigan

研究点 (1)

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