Digital STEADI Efficacy
Randomized Control Trial to Test the Efficacy of the Digital STEADI Program.
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2026
CompletedFirst Submitted
Initial submission to the registry
September 25, 2026
CompletedFirst Posted
Study publicly available on registry
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
October 1, 2026
September 1, 2026
1.7 years
September 25, 2026
September 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline fear of falling as measured by the Fall Efficacy Scale International (FES-I)
Scores will vary between 16 and 64 for the full scale. Scores between 16-19 indicate fear of falling is LOW. Scores between 20-27 indicate fear of falling is MODERATE. Scores between 28-64 indicate fear of falling is HIGH.
From enrollment to the end of the follow-up at 6 months.
Secondary Outcomes (1)
Cumulative, recurrent number of falls during the 6-month intervention period.
From randomization until the end of follow-up (6 months), withdrawal, loss to follow-up, or death
Study Arms (5)
STEADI-Avatar
EXPERIMENTALCognitively normal participants receiving the intervention via technology.
STEADI-Chat
EXPERIMENTALCognitively normal participants receiving the intervention via technology.
STEADI-Standard
ACTIVE COMPARATORCognitively normal participants receiving the intervention via traditional, non-technological means.
STEADI-Control
SHAM COMPARATORCognitively normal participants receiving an intervention via traditional, non-technological means.
STEADI MCI
EXPERIMENTALParticipants with mild cognitive impairment receiving the intervention via technology.
Interventions
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar.
STEADI fall risk screening, monitoring, and exercise program delivered and coordinated via paper and pencil and humans.
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat.
Receiving CDC Healthy Living content unrelated to fall prevention plus usual geriatric care.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Friendi.fi Corporationlead
- Emory Universitycollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Emory University School of Medicine
Atlanta, Georgia, 30329, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chantal Kerssens, MSc, PhD
Friendi.fi Corporation
- PRINCIPAL INVESTIGATOR
Madeleine E Hackney, PhD
Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2026
First Posted
October 1, 2026
Study Start
September 4, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
Data are considered proprietary in the foreseeable future and may be shared at a later time when product commercialization is completed.