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Recruiting
NCT07834684
Singula Phase 0.1 Primary Care Pilot
Conditions: Depression - Major Depressive Disorder, Anxiety
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 100
Sponsor: Singula Health, Inc.
Location: Morris Medical Office Brentwood New York
Summary
This prospective, single-arm, observational pilot study evaluates a clinical decision support system developed by Singula Health for use in primary care. Adult patients complete a self-report assessment before a routine primary care visit. The system uses the responses to generate a clinician-facing Companion Brief that summarizes relevant information for the treating clinician. Each Companion Brief is reviewed by the Principal Investigator before it is provided to the clinician. The study will evaluate whether the system can reliably generate and deliver the Companion Briefs, whether clinicians find the Briefs useful and acceptable, and whether patients can successfully complete and accept the pre-visit assessment.
Eligibility Criteria
Inclusion Criteria:
* Adult, aged 18 years or older at the time of consent.
* Scheduled for a routine, non-urgent primary care visit at a participating practice.
* Able to read and understand English at a level sufficient to complete the electronic informed consent and Survey 0.1 independently.
* Has personal-device access to complete the survey (smartphone, tablet, or computer with internet).
* Capable of providing informed consent.
Exclusion Criteria:
* Non-English-speaking, defined as inability to read English at a level sufficient to complete electronic informed consent and the survey independently.
* Visually impaired to a degree that prevents independent reading of an electronic consent form on a personal device, without specialized assistive technology beyond standard mobile-device accessibility features.
* Unable to read for any reason (literacy, cognitive impairment, or other).
* Presenting with an acute psychiatric emergency or in acute crisis at the time of the scheduled visit, as identified by clinic staff during routine check-in.
* Patient is a known minor at the time of scheduling (under 18 years).
* Patient or clinician declines participation.
Source: ClinicalTrials.gov (NCT07834684). StuddyBuddy aggregates publicly available trial information.