LonelinessBabaNCT07689526
BabaCare: Testing a Care Copilot
A study testing AI phone companion in people with Loneliness and Mood, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Mood
- What is being tested?
- AI phone companion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Bayview Campus
Baltimore, Maryland, 21224
JACQUELINE M LANGDON, M.S., 410-550-2052, jlangdon@jhmi.edu
Peter M Abadir, M.D., 410-550-0576, pabadir1@jh.edu
About this study
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.
Read the 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.
- Conditions
- Loneliness, Mood
- Being tested
- AI phone companion
- Keywords
- Loneliness in older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI phone companionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Receives calls from BABA | Experimental | Participants will receive daily or near-daily AI calls over a 12 week period. Receives: Other: AI phone companion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness as assessed by the UCLA Loneliness Scale
Pre- and post-pilot assessments will measure changes in self-reported loneliness (UCLA Loneliness Scale). Score range 20-80, higher score worse loneliness.
Measured: 12 weeks
Mood as assessed by the Patient Health Questionnare (PHQ-9)
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
Measured: 12 weeks
Mood as assessed by the Geriatric Depression scale (GDS)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start13 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Baba Care, Inc.
- Responsible party
- Sponsor
- Investigators
- Peter M Abadir, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689526
- Sponsor's protocol ID
- IRB00533251
- Other IDs
- P30AG073104
- Acronym
- Baba
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perissinotto CM, Stijacic Cenzer I, Covinsky KE. Loneliness in older persons: a predictor of functional decline and death. Arch Intern Med. 2012 Jul 23;172(14):1078-83. doi: 10.1001/archinternmed.2012.1993.
PubMed 22710744
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BabaCare: Testing a Care Copilot
- ClinicalTrials.gov ID
- NCT07689526
- Acronym / sponsor ID
- Baba / IRB00533251
- Conditions
- Loneliness, Mood
- Keywords
- Loneliness in older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Baba Care, Inc.
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Jul 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receives calls from BABA | Experimental | Other: AI phone companionParticipants will receive daily or near-daily AI calls over a 12 week period. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Lives alone
- Responds "occasionally" or "most" to the exhaustion questionnaire:
- Willingness and ability to regularly engage with Baba for 12 weeks
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| AI phone companionBaba 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. | Other | Receives calls from BABA |
Primary outcome
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 22710744Perissinotto CM, Stijacic Cenzer I, Covinsky KE. Loneliness in older persons: a predictor of functional decline and death. Arch Intern Med. 2012 Jul 23;172(14):1078-83. doi: 10.1001/archinternmed.2012.1993.
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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.
Peter M Abadir, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI phone companion in people with Loneliness and Mood, run by Johns Hopkins University 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JACQUELINE M LANGDON, M.S. (410-550-2052, jlangdon@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness as assessed by the UCLA Loneliness Scale (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07689526, which also lists 1 linked publication.
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 5 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.