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Recruiting NCT07689526

BabaCare: Testing a Care Copilot

No phase Interventional Loneliness Mood

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI phone companion.
Who it may be relevant to
Registry conditions: Loneliness, Mood. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other AI phone companion
    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 outcome measures

  • Loneliness as assessed by the UCLA Loneliness Scale [Time frame: 12 weeks]
  • Mood as assessed by the Patient Health Questionnare (PHQ-9) [Time frame: 12 weeks]
  • Mood as assessed by the Geriatric Depression scale (GDS) [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Johns Hopkins Bayview Campus — Baltimore

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. PMID 22710744

Identifiers

NCT: NCT07689526 · IRB00533251 · P30AG073104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗