CaregiversNCT07145723
Supporting Care Partners' Well-Being With Artificial Intelligence (AI) Chatbots
A study testing Earkick app in people with Caregivers, run by University of Michigan at 1 site in United States.
Trial summary
This study is being completed to test an AI therapy chatbot application called Earkick to see whether it is feasible and acceptable in supporting care partners who support individuals living with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers
- What is being tested?
- Earkick app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2025to 4 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants need to be a care partner (informal caregiver) of an individual living with dementia
- Participant provides emotional, physical, and/or financial support/assistance to the individual with dementia (per protocol)
- Participants indicate high levels of caregiver burden, confirmed using the 12-item Zarit Burden questionnaire (per protocol)
- Provide informed consent and read, speak, and understand English
- Have an Apple smartphone, tablet, or laptop, have access to the internet and text messages, and be willing to use this device as well as internet and text message access for the study, including downloading the AI chatbot app
- Be willing to complete all study assessments
Who cannot join
- Professional, paid caregivers
- Anything that would preclude safe or meaningful participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supporting Care Partners' Well-Being With AI Chatbots: A Feasibility and Acceptability Study
This study is being completed to test an AI therapy chatbot application called Earkick to see whether it is feasible and acceptable in supporting care partners who support individuals living with dementia.
- Conditions
- Caregivers
- Being tested
- Earkick app
- Keywords
- Caregivers for adults with dementia, Surveys, Care partners, Artificial intelligence (AI) mobile application, Quality of life, Chatbot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Earkick appOther
Participants will have a baseline visit followed by an 8-week home monitoring period (HMP) using the Earkick app.
The Earkick app will interact with a mental health chatbot. Participants will complete online surveys at the midpoint (4 weeks) and end (8 weeks) of the HMP. 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.
Additionally, participants will have a post-HMP interview over Zoom.
| Study group | Role | What they receive |
|---|---|---|
| Earkick app | Experimental | Not described Receives: Other: Earkick app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability as measured by the Feasibility and Acceptability Questionnaire
Feasibility and Acceptability Questionnaire (items are scaled from 1 to 5 to indicate level of agreement, where "1" indicates "strong disagreement" and "5" indicates "strong agreement").
Measured: 4 weeks and 8 weeks (post intervention)
Secondary outcomes (2)
Attrition as measured by the percent of participants completing the study
Measured: 8 weeks
Adherence as measured by the percentage of missing data over the course of the study
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start22 Sep 2025
- Primary completion23 Jan 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Newman, University of Michigan
- Investigators
- Mark Newman, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145723
- Sponsor's protocol ID
- HUM00271412
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Care Partners' Well-Being With AI Chatbots: A Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT07145723
- Acronym / sponsor ID
- HUM00271412
- Conditions
- Caregivers
- Keywords
- Caregivers for adults with dementia, Surveys, Care partners, Artificial intelligence (AI) mobile application, Quality of life, Chatbot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being completed to test an AI therapy chatbot application called Earkick to see whether it is feasible and acceptable in supporting care partners who support individuals living with dementia.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Earkick app | Experimental | Other: Earkick app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants need to be a care partner (informal caregiver) of an individual living with dementia
- Participant provides emotional, physical, and/or financial support/assistance to the individual with dementia (per protocol)
- Participants indicate high levels of caregiver burden, confirmed using the 12-item Zarit Burden questionnaire (per protocol)
- Provide informed consent and read, speak, and understand English
- Have an Apple smartphone, tablet, or laptop, have access to the internet and text messages, and be willing to use this device as well as internet and text message access for the study, including downloading the AI chatbot app
Key exclusion criteria (2 listed)
- Professional, paid caregivers
- Anything that would preclude safe or meaningful participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Earkick appParticipants will have a baseline visit followed by an 8-week home monitoring period (HMP) using the Earkick app. The Earkick app will interact with a mental health chatbot. Participants will complete online surveys at the midpoint (4 weeks) and end (8 weeks) of the HMP. 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. Additionally, participants will have a post-HMP interview over Zoom. | Other | Earkick app |
Primary outcome
Feasibility and Acceptability as measured by the Feasibility and Acceptability Questionnaire
Time frame: 4 weeks and 8 weeks (post intervention)
Feasibility and Acceptability Questionnaire (items are scaled from 1 to 5 to indicate level of agreement, where "1" indicates "strong disagreement" and "5" indicates "strong agreement").
2 secondary outcomes
Attrition as measured by the percent of participants completing the study
Time frame: 8 weeks
Adherence as measured by the percentage of missing data over the course of the study
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Newman, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Earkick app in people with Caregivers, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability as measured by the Feasibility and Acceptability Questionnaire (time frame: 4 weeks and 8 weeks (post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.