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

2 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

168

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Kyeung Mi Oh, PhD
  • Numer telefonu: 703 993 4550
  • E-mail: koh5@gmu.edu

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: LifeBio Memory (LBM) digital reminiscence 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.
Aktywny komparator: 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.
Inny: LifeBio Memory (LBM) digital reminiscence 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Primary Outcome
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Center for Epidemiologic Studies Depression Scale (CES-D)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

George Mason University

Współpracownicy

National Institute on Aging (NIA)

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

31 maja 2028

Ukończenie studiów (Szacowany)

31 maja 2028

Daty rejestracji na studia

Pierwszy przesłany

17 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 lipca 2026

Pierwszy wysłany (Rzeczywisty)

6 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lipca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • koh5
  • 2R44AG069566-03A1 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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