NCT07852650 · Friendi.fi Corporation
Digital STEADI Efficacy
What this study is about
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).
View original scientific 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
BEHAVIORAL
Digital STEADI-1
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar.
BEHAVIORAL
STEADI Standard of Care
STEADI fall risk screening, monitoring, and exercise program delivered and coordinated via paper and pencil and humans.
BEHAVIORAL
Digital STEADI-2
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat.
BEHAVIORAL
Attentional control
Receiving CDC Healthy Living content unrelated to fall prevention plus usual geriatric care.
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Atlanta, Georgia
Collaborators
Emory University, National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2026 · Source of record for eligibility and locations