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LifeBio Memory: Development of a Reminiscence Therapy Online Platform With Machine Learning to Increase Engagement (LifeBio Memory)

2 de julho de 2026 atualizado por: Kyeung Mi Oh, George Mason University
LifeBioMEMORY (LBM) is a reminiscence therapy (RT) mobile application that captures older adults' life stories in their own voices to promote social engagement and psychosocial well-being. This study will develop and evaluate an enhanced multilingual LBM app for community-dwelling, diverse older adults with mild cognitive impairment (MCI) or at risk of MCI and their informal caregivers, including Hispanic/Latino, Asian American (as one of subgroups, Korean), Black or African American, and non-Hispanic White populations. The app provides culturally tailored life story prompts with audio and visual cues to encourage reminiscence and storytelling. The intervention aims to improve quality of life, reduce depressive symptoms and loneliness, and strengthen caregiver-care recipient relationships, with the potential to provide an accessible, non-pharmacological approach to supporting cognitive and emotional well-being.

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

168

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Kyeung Mi Oh, PhD
  • Número de telefone: 703 993 4550
  • E-mail: koh5@gmu.edu

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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:

  1. Self-identified as Hispanic/Latino, Korean, Black/African American, and Non-Hispanic White
  2. Speak and read Spanish, Korean, or English
  3. 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)
  4. Have a local or in-home informal caregiver who can participate who is age 18 or older
  5. No pre-existing acute psychotic disease or critical illness
  6. Consent to participate

The inclusion and exclusion criteria for informal caregivers are:

  1. Self-identified as Hispanic/Latino, Korean, Black/African American, and Non-Hispanic White
  2. Speak and read Spanish, Korean, or English
  3. Aged 18 years and older
  4. Currently serving as the primary informal caregiver for older adults aged 60 or older
  5. No pre-existing acute psychotic disease or critical illness
  6. Consent to participate

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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 Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Primary Outcome
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Center for Epidemiologic Studies Depression Scale (CES-D)
Prazo: 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)
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

31 de maio de 2028

Conclusão do estudo (Estimado)

31 de maio de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

17 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de julho de 2026

Primeira postagem (Real)

6 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de julho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • koh5
  • 2R44AG069566-03A1 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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