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NCT Number: NCT07689526

BabaCare: Testing a Care Copilot

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.

Recruiting

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI phone companion

Other

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

JACQUELINE M LANGDON, M.S.

CONTACT

[email protected]

410-550-2052

Peter M Abadir, M.D.

CONTACT

[email protected]

410-550-0576

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Baba Care, Inc.
  • National Institute on Aging (NIA)

Registry information

Acronym: Baba

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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