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

April 14, 2026 updated by: Noelle E Carlozzi, University of Michigan

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Noelle Carlozzi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Earkick app
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks (post intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to post intervention interview (approximately 8-12 weeks)
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).
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Noelle Carlozzi, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00265379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participant data collected during the trial, after de-identification, will be available for sharing with individuals in the scientific community, upon request, at the discretion of the Principal Investigator. The data will be available after the acceptance for publication of the main findings from the final dataset. The University of Michigan project manager will coordinate requests for data and maintain documentation for requests and distributions. An institutional data use agreement will be required before data is shared.

IPD Sharing Time Frame

The data will be available after the acceptance for publication of the main findings from the final dataset.

IPD Sharing Access Criteria

Data is available upon request to the project manager. Requests for data sharing should be emailed to PMR-CODALab@med.umich.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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