- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07689526
BabaCare: Testing a Care Copilot (Baba)
July 1, 2026 updated by: Johns Hopkins University
Baba is a novel AI "care copilot" designed to improve emotional well-being, cognitive stimulation, and social connection through emotionally present conversations, proactive engagement, and personalized communication.
Unlike many existing solutions, Baba operates through SMS text and voice calls, requiring no apps, Wi-Fi, or new devices, making it particularly accessible to older adults.
Study Overview
Detailed Description
The purpose of this study is to evaluate the feasibility, usability, and preliminary impact of the Baba platform among older adults.
This study will examine how older adults interact with Baba, how it integrates into the older adult's daily lives, and whether it contributes to improvements in well-being, cognitive engagement, and self-management.
Findings will inform the feasibility of AI companions in supporting independent aging.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: JACQUELINE M LANGDON, M.S.
- Phone Number: 410-550-2052
- Email: jlangdon@jhmi.edu
Study Contact Backup
- Name: Peter M Abadir, M.D.
- Phone Number: 410-550-0576
- Email: pabadir1@jh.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Recruiting
- Johns Hopkins Bayview Campus
-
Contact:
- JACQUELINE M LANGDON, M.S.
- Phone Number: 410-550-2052
- Email: jlangdon@jhmi.edu
-
Contact:
- Peter M Abadir, M.D.
- Phone Number: 410-550-0576
- Email: pabadir1@jh.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Lives alone
Responds "occasionally" or "most" to the exhaustion questionnaire:
- "How often in the last week did you feel that everything you did was an effort?"
- "How often in the last week did you feel that you could not get going?"
- Willingness and ability to regularly engage with Baba for 12 weeks
Exclusion Criteria:
- Significant cognitive impairment that prevents consent or participation
- Inability to communicate via SMS or phone
- Severe hearing or speech impairment precluding use of voice interaction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Receives calls from BABA
Participants will receive daily or near-daily AI calls over a 12 week period.
|
Baba uses a fine-tuned large language model to hold conversations with older adults and analyze tone, sentiment shifts, and emotional cues.
The system logs call summaries and risk flags for caregiver review and tracks changes over time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness as assessed by the UCLA Loneliness Scale
Time Frame: 12 weeks
|
Pre- and post-pilot assessments will measure changes in self-reported loneliness (UCLA Loneliness Scale).
Score range 20-80, higher score worse loneliness.
|
12 weeks
|
|
Mood as assessed by the Patient Health Questionnare (PHQ-9)
Time Frame: 12 weeks
|
Pre- and post-pilot assessments will measure changes in self-reported mood (PHQ-9 or GDS).
Total score range 0 to 27, with higher score indicating more severe depressive symptoms
|
12 weeks
|
|
Mood as assessed by the Geriatric Depression scale (GDS)
Time Frame: 12 weeks
|
Pre- and post-pilot assessments will measure changes in self-reported mood Total score range 0-15, with higher score indicating worse depression.
A score ≥ 5 typically suggests depression.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter M Abadir, M.D., Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
July 1, 2026
First Submitted That Met QC Criteria
July 1, 2026
First Posted (Actual)
July 8, 2026
Study Record Updates
Last Update Posted (Actual)
July 8, 2026
Last Update Submitted That Met QC Criteria
July 1, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00533251
- P30AG073104 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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