Phase 1/2Recruiting
Digital STEADI Efficacy
Randomized Control Trial to Test the Efficacy of the Digital STEADI Program.
- Sponsor
- Friendi.fi Corporation (Industry)
- Enrolment
- 300 planned
- Conditions
- Fall; Mild Cognitive Impairment (MCI); Aging
- Interventions
- Digital STEADI-1; STEADI Standard of Care; Digital STEADI-2; Attentional control
- Ages
- adults, older adults
- Registry
- NCT07852650
From the registry
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.
Primary outcomes
- Change from baseline fear of falling as measured by the Fall Efficacy Scale International (FES-I)