LifeBio Memory: Development of a Reminiscence Therapy Online Platform With Machine Learning to Increase Engagement (LifeBio Memory)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Alzheimer's Disease and Related Dementias (ADRD) are becoming more prevalent in the United States. It is expected that the number of people affected will increase to 7.2 million by 2025 and 11.2 million by 2040. This is accompanied by a staggering cost of care, amounting to $345 billion annually in the US alone, with Medicare and Medicaid accounting for $222 billion of that amount. Globally, the cost of dementia is estimated to be over $1.3 trillion in 2021, and it is expected to rise to $2.8 trillion by 2030.
The effectiveness of LifeBioMEMORY (LBM) technology has shown promise in increasing engagement and social support through life story capture and RT opportunities among institutionalized older adults with cognitive impairment and formal caregivers. More than 1,000 individuals have been voice recorded in nursing home or residential living settings as a result of LBM Phase II SBIR grant. LBM's Phase IIB renewal application is to continue research and development and to advance toward further commercialization, with NIA's commitment to funding R&D for interventions for prevention or treatment of MCI and ADRD. With LMM Phase IIB based on RT and now capturing life stories in older adults' own voices, the investigtors propose to build and then validate an enhanced multi-language version of the LBM app with a diverse, non-institutionalized population to investigate linguistic and cultural appropriateness, focusing on Hispanic/Latinx, Asian American (as one of subgroups, Korean), Black or African-American, and non-Hispanic White older adults with MCI or at risk of MCI and their informal caregivers.
The specific aims of this SBIR application are to: 1) Update the LBM for culturally relevant multi-lingual support, 2) Assess its usability, and 3) Evaluate its feasibility, acceptability, and initial efficacy through a randomized waitlist-controlled trial using a mixed methods approach among diverse racial and ethnic dyads, each consisting of an older adult participant (with MCI or at risk of MCI) and an informal caregiver. This involves 84 older adult participants and 84 informal caregivers, including 21 Hispanic/Latinx, 21 Korean, 21 Black or African American, and 21 non-Hispanic White dyads. Outcomes such as health-related quality of life, depression, relationship closeness, and loneliness will be measured at baseline, 4 weeks post-follow-up, and 12 weeks post-follow-up. Additionally, user activities and qualitative interviews will be used to understand user experience, leading to recommended changes to the LBM interface by LifeBio as a result of Aims 2 and 3.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kyeung Mi Oh, PhD
- Número de teléfono: 703 993 4550
- Correo electrónico: koh5@gmu.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
The investigators will enroll a total of 84 older adult participants and 84 informal caregivers across the 84 dyads, comprising 21 Hispanic/Latino dyads, 21 Korean dyads, 21 Black dyads, and 21 Non-Hispanic White dyads.
The inclusion and exclusion criteria for older adult participants are:
- Self-identified as Hispanic/Latino, Korean, Black/African American, and Non-Hispanic White
- Speak and read Spanish, Korean, or English
- Aged 60 years and older, with Montreal Cognitive Assessment (MoCA) test scores ranging 18-30 (with MCI: 18-25, or at risk for MCI: 26-30)
- Have a local or in-home informal caregiver who can participate who is age 18 or older
- No pre-existing acute psychotic disease or critical illness
- Consent to participate
The inclusion and exclusion criteria for informal caregivers are:
- Self-identified as Hispanic/Latino, Korean, Black/African American, and Non-Hispanic White
- Speak and read Spanish, Korean, or English
- Aged 18 years and older
- Currently serving as the primary informal caregiver for older adults aged 60 or older
- No pre-existing acute psychotic disease or critical illness
- Consent to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: LifeBio Memory (LBM) digital reminiscence intervention
Participants will access the LifeBio Memory (LBM) digital reminiscence platform using a mobile phone or tablet.
Informal caregivers will complete a brief training.
During Weeks 1-2, dyads will complete at least two weekly sessions recording the older adult's life stories using structured prompts.
During Weeks 3-5, dyads will complete one weekly reminiscence and social engagement session.
In Week 6, participants will receive personalized LifeBio story materials, including a Life Story Book, Snapshot, and story summary.
|
LifeBioMEMORY (LBM) is a multilingual digital reminiscence therapy platform that guides older adults through life story sharing using culturally relevant prompts, photos, and voice recording in Spanish, Korean, or English.
The app includes "My Story" and "Fun Things to Do" features to support reminiscence and engagement while capturing personal narratives.
Using machine learning, LBM generates personalized Life Story Books and summaries in the preferred language of the older adult and informal caregiver, with electronic and printed copies available.
The intervention is designed to promote social engagement, strengthen caregiver relationships, and support person-centered care.
|
|
Comparador activo: Waitlist Control (Delayed LBM digital reminiscence intervention)
Participants will receive general education on brain health and information about available local social services during the control period.
After the control period, participants will participate in the LifeBio Memory (LBM) App intervention.
|
LifeBioMEMORY (LBM) is a multilingual digital reminiscence therapy platform that guides older adults through life story sharing using culturally relevant prompts, photos, and voice recording in Spanish, Korean, or English.
The app includes "My Story" and "Fun Things to Do" features to support reminiscence and engagement while capturing personal narratives.
Using machine learning, LBM generates personalized Life Story Books and summaries in the preferred language of the older adult and informal caregiver, with electronic and printed copies available.
The intervention is designed to promote social engagement, strengthen caregiver relationships, and support person-centered care.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Primary Outcome
Periodo de tiempo: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
|
Health-Related Quality of Life (SF-12 Physical and Mental Component Summary Scores)
|
Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale (CES-D)
Periodo de tiempo: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
|
The Center for Epidemiologic Studies Depression Scale (CES-D) measures depressive symptoms.
Total scores range from 0 to 60, with higher scores indicating greater depressive symptoms (worse outcome).
|
Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
|
|
Relationship Closeness Scale (RCS)
Periodo de tiempo: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
|
The Relationship Closeness Scale (RCS) measures perceived emotional closeness and relationship quality between the caregiver and care recipient.
Total scores range from 6 to 24, with higher scores indicating greater relationship closeness (better outcome).
|
Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
|
|
UCLA Loneliness Scale
Periodo de tiempo: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
|
The 3-Item UCLA Loneliness Scale (UCLA-LS-3) measures perceived loneliness and social isolation.
Total scores range from 3 to 9, with higher scores indicating greater loneliness (worse outcome).Time Frame: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
|
Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
- koh5
- 2R44AG069566-03A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .