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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07280650
Enrollment
60
Registered
2025-12-12
Start date
2026-08-01
Completion date
2027-06-30
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers

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

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.

Interventions

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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The study will recruit approximately 20 care partners of individuals with TBI, 20 care partners of individuals with dementia, and 20 care partners of individuals with Huntington Disease

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and Acceptability as measured by the Feasibility Questionnaire8 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

MeasureTime frameDescription
Attrition as measured by the percent of participants completing the studyBaseline to post intervention interview (approximately 8-12 weeks)The study team expects ≥80% of participants to complete the study.
Adherence as measured by the percentage of missing data over the course of the studyBaseline to 8 weeksPercent 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).

Countries

United States

Contacts

CONTACTChristopher Graves
gravesch@med.umich.edu734-764-7004
PRINCIPAL_INVESTIGATORNoelle Carlozzi, PhD

University of Michigan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026