What this study is
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.
What's being tested
- LLM-based Chatbot
Intervention · 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.
Study details
- Sponsor
- University of Michigan
- Conditions
- Caregivers
- Enrolling
- 60 people
- Starts
- 2026-09-02
- Est. completion
- 2027-07-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedcare partner
You may qualify if
- 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
You can't join if
- 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
care recipient
You may qualify if
- Age 18 years or older
- Have a medically documented diagnosis of TBI, dementia or Huntington disease as noted per protocol
You can't join if
- Anyone not meeting inclusion criteria
- Lives in a care facility (assisted living, nursing home) or is bedbound
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Michigan
Ann Arbor, Michigan, United States
- Christopher Graves · Contact734-764-7004gravesch@med.umich.edu
- Noelle Carlozzi, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Michigan
Study ID HUM00265379
Principal investigator
Noelle Carlozzi, PhD
University of Michigan
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.