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Not yet recruiting Not applicable NCT07280650

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

No applicable phase (e.g. observational)
Conditions: Caregivers

Sponsor: University of Michigan

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria (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 Exclusion Criteria (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
Interventions
LLM-based Chatbot
OTHER
Locations 1
United States (1)
University of Michigan
Ann Arbor , Michigan
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.08.2026
Completion date
30.06.2027
Registry ID
NCT07280650
Source
clinicaltrials.gov
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