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

2 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

168

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Kyeung Mi Oh, PhD
  • Numero di telefono: 703 993 4550
  • Email: koh5@gmu.edu

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Primary Outcome
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Center for Epidemiologic Studies Depression Scale (CES-D)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 maggio 2028

Completamento dello studio (Stimato)

31 maggio 2028

Date di iscrizione allo studio

Primo inviato

17 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • koh5
  • 2R44AG069566-03A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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