Recruiting

AI Chatbot

Sponsor:

University of Michigan

Code:

NCT07280650

Conditions

Caregivers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LLM-based Chatbot

Study Details

Brief summary:

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.

Conditions

Caregivers

Study ID

NCT07280650

Start date

Sep 2, 2026

Status verified date

Oct, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Earkick app

Interventions

LLM-based Chatbot

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 outcome measure

  • Feasibility and Acceptability as measured by the Feasibility Questionnaire [ Time Frame: 8 weeks (post intervention) ]

Central Contacts and Locations

Central contacts

Christopher Graves

734-764-7004gravesch@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Christopher Graves

734-764-7004gravesch@med.umich.edu

Principal Investigator:

Noelle Carlozzi, PhD

More Information

Sponsor

University of Michigan

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • Caregivers for adults with Traumatic Brain Injury (TBI)
  • Caregivers for adults with dementia
  • Caregivers for adults with Huntington disease
  • Artificial intelligence (AI) mobile application
  • Chatbot
  • Surveys

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.