LifeBio Memory: Development of a Reminiscence Therapy Online Platform With Machine Learning to Increase Engagement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 主要终点
- Primary Outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Primary Outcome
时间窗: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
Health-Related Quality of Life (SF-12 Physical and Mental Component Summary Scores)
次要结局
- Center for Epidemiologic Studies Depression Scale (CES-D)(Assessments will be conducted at baseline, 6 weeks, and 10 weeks.)
- Relationship Closeness Scale (RCS)(Assessments will be conducted at baseline, 6 weeks, and 10 weeks.)
- UCLA Loneliness Scale(Assessments will be conducted at baseline, 6 weeks, and 10 weeks.)
研究者
Kyeung Mi Oh
Principal Investigator
George Mason University