Digital STEADI Efficacy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorFriendi.fi Corporation
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Digital STEADI-1
BehavioralSTEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar.
STEADI Standard of Care
BehavioralSTEADI fall risk screening, monitoring, and exercise program delivered and coordinated via paper and pencil and humans.
Digital STEADI-2
BehavioralSTEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat.
Attentional control
BehavioralReceiving CDC Healthy Living content unrelated to fall prevention plus usual geriatric care.
Treatment groups
300 Participants
are divided into 5 treatment groupsGroup A: STEADI-AvatarExperimental treatment 1 intervention
Group B: STEADI-ChatExperimental treatment 1 intervention
Group C: STEADI-StandardActive comparator 1 intervention
Group D: STEADI-ControlSham comparator 1 intervention
Group E: STEADI MCIExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
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.
Participants will report fall status weekly and achieve a response if they report falling in the week preceding the report.
Time frame
From randomization until the end of follow-up (6 months), withdrawal, loss to follow-up, or deathSponsors and contacts
Click on the lead sponsor to view all of their trials.
Friendi.fi Corporation
Lead sponsor
Emory University
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov