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

NCT07280650 | Not Yet Recruiting

• 1 other identifier: HUM00265379
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Feasibility and Acceptability as measured by the Feasibility Questionnaire

  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.

  8 weeks (post intervention)

Secondary Outcomes (2)

• Attrition as measured by the percent of participants completing the study

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

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

  Baseline to 8 weeks

Study Arms (1)

Earkick app

EXPERIMENTAL

Other: LLM-based Chatbot

Interventions

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.

Earkick app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Age 18 years or older
• Have a medically documented diagnosis of TBI, dementia or Huntington disease as noted per protocol

You may not qualify if:

• Professional, paid caregivers
• Anyone at the discretion of the Principal investigator (PI) that would be a preclusion of safe or meaningful participation
• Lives in a care facility (assisted living, nursing home) or is bedbound

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Noelle Carlozzi, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Graves

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available after the acceptance for publication of the main findings from the final dataset.
• Access Criteria: Data is available upon request to the project manager. Requests for data sharing should be emailed to PMR-CODALab@med.umich.edu

Locations

US (1)