RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Digital STEADI Efficacy

Sponsor: Friendi.fi Corporation • ClinicalTrials.gov ID: NCT07852650

Registry updated: 2026-10-01

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Description

The aging of the U.S. population, combined with health care workforce shortages and insufficient access to effective fall prevention and exercise programs, has contributed to a high burden of fall-related injuries in older adults, especially in those with Mild Cognitive Impairment (MCI), a precursor of Alzheimer's dementia (AD) and related dementias (ADRD). There is an urgent need for scalable, evidence-based interventions that can be delivered efficiently in the home setting. This study aims to evaluate the efficacy and impact of a comprehensive digital fall prevention program (Digital STEADI) delivered through a technology platform with two conversational agents that leverage generative artificial intelligence (gen-AI) with human oversight to increase program access, enhance adherence to clinical fall prevention protocols and best practices, and reduce fall risk among community-dwelling older adults.

Interventions

Digital STEADI-1 (Behavioral)
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar.
STEADI Standard of Care (Behavioral)
STEADI fall risk screening, monitoring, and exercise program delivered and coordinated via paper and pencil and humans.
Digital STEADI-2 (Behavioral)
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat.
Attentional control (Behavioral)
Receiving CDC Healthy Living content unrelated to fall prevention plus usual geriatric care.

Eligibility criteria

Inclusion Criteria: * Montreal Cognitive Assessment (MoCA) score between 26 and 30 * Able to walk independently with or without an assistive device. * Able to rise independently from a standard desk or dining room chair without arms. * Live independently in a non-institutional or senior community setting. * Able to speak, hear and understand English * Have 20/40 vision from 10 ft with or without correction (e.g., glasses) * Willing to participate in the requirements of the research program. * Able to meet in a physical study location on Emory campus. * Screen positive for fall risk per the Stay Independent screener. Exclusion Criteria: * acute medical illness requiring hospitalization. * hospitalized in the past 1 month. * diagnosed with dementia (ADRD) or a neurodegenerative disease other than MCI (e.g., Parkinson's, multiple sclerosis). * uncontrolled congestive heart failure (requiring hospitalization in the past year and/or unable to the equivalent of one city block). * history of hospitalization for stroke in the past 1 year. * inability to perform study procedures.

Conditions

Fall Mild Cognitive Impairment (MCI) Aging

Locations

Emory University School of Medicine — Atlanta, Georgia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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