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

Overview

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

• 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

Primary outcome measures

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

Secondary outcome measures (2)

• Attrition as measured by the percent of participants completing the study [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT07280650 · HUM00265379

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗