NCT07145723

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2026

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

August 20, 2025

Last Update Submit

March 31, 2026

Conditions

Keywords

Caregivers for adults with dementiaSurveysCare partnersArtificial intelligence (AI) mobile applicationQuality of lifeChatbot

Outcome Measures

Primary Outcomes (1)

  • 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").

    4 weeks and 8 weeks (post intervention)

Secondary Outcomes (2)

  • Attrition as measured by the percent of participants completing the study

    8 weeks

  • Adherence as measured by the percentage of missing data over the course of the study

    8 weeks

Study Arms (1)

Earkick app

EXPERIMENTAL
Other: Earkick app

Interventions

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.

Earkick app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Professional, paid caregivers
  • Anything that would preclude safe or meaningful participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Mark Newman, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Information

Study Record Dates

First Submitted

August 20, 2025

First Posted

August 28, 2025

Study Start

September 22, 2025

Primary Completion

January 23, 2026

Study Completion

February 4, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations