Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT07280650
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07280650
Study Brief:
Protocol Section:
NCT07280650