NCT07689526

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jul 2026Jun 2027

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 13, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

July 1, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

Loneliness in older adults

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    12 weeks

Study Arms (1)

Receives calls from BABA

EXPERIMENTAL

Participants will receive daily or near-daily AI calls over a 12 week period.

Other: AI phone companion

Interventions

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.

Receives calls from BABA

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Campus

Baltimore, Maryland, 21224, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22710744BACKGROUND

Study Officials

  • Peter M Abadir, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JACQUELINE M LANGDON, M.S.

CONTACT

Peter M Abadir, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

July 13, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 5, 2026

Record last verified: 2026-08

Locations