Digital STEADI Efficacy

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Friendi.fi Corporation
Study ID
NCT07852650
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Aging
  • Fall
  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Oct 1, 2026
Start date
Sep 4, 2026
Status verified
Sep 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: STEADI-Avatar
    Cognitively normal participants receiving the intervention via technology.
  • Experimental: STEADI-Chat
    Cognitively normal participants receiving the intervention via technology.
  • Active Comparator: STEADI-Standard
    Cognitively normal participants receiving the intervention via traditional, non-technological means.
  • Sham Comparator: STEADI-Control
    Cognitively normal participants receiving an intervention via traditional, non-technological means.
  • Experimental: STEADI MCI
    Participants with mild cognitive impairment receiving the intervention via technology.

Primary Outcome Measure

Change from baseline fear of falling as measured by the Fall Efficacy Scale International (FES-I) [ Time Frame: From enrollment to the end of the follow-up at 6 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University School of MedicineAtlantaGeorgia30329-

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By research site
Emory University School of Medicine· Atlanta, GA

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