Digital STEADI Efficacy
Randomized Control Trial to Test the Efficacy of the Digital STEADI Program.
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The Centers for Disease Control and Prevention's (CDC) Stopping Elderly Accidents, Deaths & Injuries (STEADI) Initiative integrates fall risk screening, assessment, and intervention according to established clinical guidelines from the American and British Geriatrics Societies. Although STEADI is a proven multifactorial intervention, traditional dissemination models relying on in-person visits, paper-based materials, and intensive human monitoring and care coordination present significant barriers to widespread implementation for impact at the population level.
The sponsor in collaboration with clinical and academic partners, will test a digital STEADI intervention program incorporating an evidence-based exercise program (Otago, OEP) to provide strength and balance training and continuous coaching. The digital program is implemented via two conversational agents, a tablet-based avatar or mobile chat via SMS, supported by gen-AI and trained human staff who supervise the agents as needed. Both agents provide 24x7 companionship with protocolized health coaching and escalation to care providers as needed. The technology has been rigorously validated in cognitively normal (CN) as well as frail older adults with multiple chronic conditions including serious mental illness (SMI), MCI and ADRD. It is optimized for ongoing fall risk monitoring, personalized exercise prescription, and coordinated care. The full digital STEADI program was successfully tested for feasibility and safety in two pilot studies with older adults with and without MCI, one in a simulated home environment and another in private homes of community-dwelling older adults. Upon the successful completion of the randomized control trial (RCT), the Digital STEADI program will be prepared for national implementation and commercialization.
A randomized control trial (RCT, N= 300) will be conducted to evaluate the efficacy of the digital STEADI program including OEP compared to standard STEADI (STEADI-Standard) and attentional control (STEADI-Control) conditions. A subset of participants with MCI will be assigned to the STEADI-Avatar group to evaluate the digital program in this high-risk population. All participants will be community-dwelling older adults aged ≥50 years at risk for falls.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chantal Kerssens, MSc, PhD
- Número de teléfono: 404-282-0378
- Correo electrónico: chantal@friendi.fi
Copia de seguridad de contactos de estudio
- Nombre: Cheri Maggard, M.A.
- Correo electrónico: cheri@friendi.fi
Ubicaciones de estudio
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30329
- Reclutamiento
- Emory University School of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: STEADI-Avatar
Cognitively normal participants receiving the intervention via technology. |
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar. |
|
Experimental: STEADI-Chat
Cognitively normal participants receiving the intervention via technology. |
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via SMS chat. |
|
Comparador activo: STEADI-Standard
Cognitively normal participants receiving the intervention via traditional, non-technological means. |
STEADI fall risk screening, monitoring, and exercise program delivered and coordinated via paper and pencil and humans. |
|
Comparador falso: STEADI-Control
Cognitively normal participants receiving an intervention via traditional, non-technological means. |
Receiving CDC Healthy Living content unrelated to fall prevention plus usual geriatric care. |
|
Experimental: STEADI MCI
Participants with mild cognitive impairment receiving the intervention via technology. |
STEADI fall risk screening, monitoring and exercise program delivered and coordinated via tablet-based avatar. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline fear of falling as measured by the Fall Efficacy Scale International (FES-I)
Periodo de tiempo: 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. |
From enrollment to the end of the follow-up at 6 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cumulative, recurrent number of falls during the 6-month intervention period.
Periodo de tiempo: From randomization until the end of follow-up (6 months), withdrawal, loss to follow-up, or death
|
Participants will report fall status weekly and achieve a response if they report falling in the week preceding the report. |
From randomization until the end of follow-up (6 months), withdrawal, loss to follow-up, or death
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Chantal Kerssens, MSc, PhD, Friendi.fi Corporation
- Investigador principal: Madeleine E Hackney, PhD, Emory University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R44AG085913_RCT
- R44AG085913 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Data are considered proprietary in the foreseeable future and may be shared at a later time when product commercialization is completed.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .