Recruiting
Phase 1
Phase 2

Digital STEADI

Sponsor:

Friendi.fi Corporation

Code:

NCT07852650

Conditions

Fall

Mild Cognitive Impairment (MCI)

Aging

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Digital STEADI-1

STEADI Standard of Care

Digital STEADI-2

Attentional control

Study Details

Brief summary:

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.

Conditions

Fall

Mild Cognitive Impairment (MCI)

Aging

Study ID

NCT07852650

Start date

Sep 4, 2026

Status verified date

Sep, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Digital STEADI-1

STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar.

STEADI Standard of Care

STEADI fall risk screening, monitoring, and exercise program delivered and coordinated via paper and pencil and humans.

Digital STEADI-2

STEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat.

Attentional control

Receiving CDC Healthy Living content unrelated to fall prevention plus usual geriatric care.

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 and Locations

Central contacts

Chantal Kerssens, MSc, PhD

404-282-0378chantal@friendi.fi

Cheri Maggard, M.A.

cheri@friendi.fi

Locations

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Friendi.fi Corporation

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • fall prevention
  • older adults
  • artificial intelligence
  • conversational agents
  • chatbot
  • avatar

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Friendi.fi Corporation on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.