About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Anyone not meeting inclusion criteria
Trial design
Single group
Treatments tested in this trial
LLM-based Chatbot
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Attrition as measured by the percent of participants completing the study
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 study
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).
Sponsors and contacts
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