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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Earkick app | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Attrition as measured by the percent of participants completing the study | 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 |
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Inclusion Criteria (care partner)
Inclusion Criteria (care recipient):
Exclusion Criteria (care partner)
Exclusion Criteria (care recipient):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Graves | Contact | 734-764-7004 | gravesch@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Noelle Carlozzi, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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.
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The data will be available after the acceptance for publication of the main findings from the final dataset.
Data is available upon request to the project manager. Requests for data sharing should be emailed to PMR-CODALab@med.umich.edu
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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
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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 |