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NCT Number: NCT07280650

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

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.

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Key information

Conditions

Caregivers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location contact

Christopher Graves

CONTACT

[email protected]

734-764-7004

Noelle Carlozzi, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LLM-based Chatbot

Other

Participants will download the app with the study team's help and set it up. The participants will select topics of interest to focus on during the 8-week use of the LLM-based Chatbot. Participants will choose one mental health related topic to focus on from weeks 1-4 and one physical health related topic to focus on from weeks 5-8. During these 4 week cycles the participants will be guided to engage with the app's "Chat" feature, which offers conversational support through interactions with the chatbot. Additionally, participants will complete surveys at baseline, the midpoint, and end of the 8-week intervention period. Participants will also complete a semi-structured interview to discuss their experience using the LLM-based Chatbot.

Primary outcomes

  1. Feasibility and Acceptability as measured by the Feasibility Questionnaire

    Time frame: 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.

Secondary outcomes

  1. Attrition as measured by the percent of participants completing the study

    Time frame: Baseline to post intervention interview (approximately 8-12 weeks)

    The study team expects ≥80% of participants to complete the study.

  2. Adherence as measured by the percentage of missing data over the course of the study

    Time frame: Baseline to 8 weeks

    Percent missing data of total expected data for each person and on average will also be calculated to characterize the feasibility of this approach (i.e., the study team expects ≥80% completion rates for the midpoint and end-of-study assessments).

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Graves

CONTACT

[email protected]

734-764-7004

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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