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Feasibility and Acceptability of Earkick for Family Caregivers: Evaluation Study

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University of Michigan

Status

Begins enrollment this month

Conditions

Caregivers

Treatments

Other: Earkick app

Study type

Interventional

Funder types

Other

Identifiers

NCT07280650
HUM00265379

Details and patient eligibility

About

This study evaluates the feasibility and acceptability of using the artificial intelligence (AI) chatbot mobile application (called Earkick) 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 the Earkick app.

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Earkick app
Experimental group
Treatment:
Other: Earkick app

Trial contacts and locations

1

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Central trial contact

Christopher Graves

Data sourced from clinicaltrials.gov

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