[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07689526":3,"trial-entities:NCT07689526":94,"trial-summary:NCT07689526":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":60,"locations":62,"central_contacts":82,"overall_officials":85,"references":88,"see_also_links":93},"NCT07689526","IRB00533251","BabaCare: Testing a Care Copilot","RECRUITING","2027-06","2026-07","2026-07-08","Johns Hopkins University","OTHER",false,"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.","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.",[17,18],"Loneliness","Mood",[20],"Loneliness in older adults","INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},40,"ESTIMATED",[29],{"type":12,"name":30,"description":31,"armGroupLabels":32},"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.",[33],"Receives calls from BABA",[35,39,42],{"measure":36,"description":37,"timeFrame":38},"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",{"measure":40,"description":41,"timeFrame":38},"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",{"measure":43,"description":44,"timeFrame":38},"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.",[],"ALL","65 Years",null,true,{"inclusion":51,"exclusion":55,"raw_text":59},[52,53,54],"Lives alone","Responds \"occasionally\" or \"most\" to the exhaustion questionnaire:","Willingness and ability to regularly engage with Baba for 12 weeks",[56,57,58],"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","Inclusion Criteria:\n\n* Lives alone\n* Responds \"occasionally\" or \"most\" to the exhaustion questionnaire:\n\n  1. \"How often in the last week did you feel that everything you did was an effort?\"\n  2. \"How often in the last week did you feel that you could not get going?\"\n* Willingness and ability to regularly engage with Baba for 12 weeks\n\nExclusion Criteria:\n\n* Significant cognitive impairment that prevents consent or participation\n* Inability to communicate via SMS or phone\n* Severe hearing or speech impairment precluding use of voice interaction",[61],"OLDER_ADULT",[63],{"facility":64,"status":7,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":79},"Johns Hopkins Bayview Campus","Baltimore","Maryland","21224","United States",[70,75],{"name":71,"role":72,"phone":73,"email":74},"JACQUELINE M LANGDON, M.S.","CONTACT","410-550-2052","jlangdon@jhmi.edu",{"name":76,"role":72,"phone":77,"email":78},"Peter M Abadir, M.D.","410-550-0576","pabadir1@jh.edu",{"lat":80,"lon":81},39.29038,-76.61219,[83,84],{"name":71,"role":72,"phone":73,"email":74},{"name":76,"role":72,"phone":77,"email":78},[86],{"name":76,"affiliation":11,"role":87},"PRINCIPAL_INVESTIGATOR",[89],{"pmid":90,"type":91,"citation":92},"22710744","BACKGROUND","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\u002Farchinternmed.2012.1993.",[],{"nct_id":4,"conditions":95,"biomarkers":97},[17,96],"Mood Disorder",[],{"nct_id":4,"found":49,"summary":99,"prompt_version":109},{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an interventional study with a planned enrollment of 40 participants. It is designed to evaluate the feasibility, usability, and preliminary impact of the Baba platform.","completed","BabaCare: Testing an AI Phone Companion for Loneliness and Mood","This study is testing Baba, an AI phone companion that uses a special computer program (large language model) to have conversations with older adults. Baba aims to improve emotional well-being, social connection, and thinking skills by talking to you and noticing changes in your mood. It works through regular phone calls and texts, so you don't need special apps or Wi-Fi. We want to see if Baba can help reduce feelings of loneliness and improve your mood. You might be able to join if you are 65 or older, live alone, and sometimes feel exhausted. We will measure your loneliness and mood after 12 weeks to see if Baba is helpful. The current recruitment status is unclear.","Your loneliness and mood will be assessed at 12 weeks after starting the intervention.",117,"You would regularly engage with Baba for 12 weeks. Your loneliness and mood will be assessed at the end of this period.","Not stated in the trial record.",[30],"v2"]