LifeBio Memory Digital Reminiscence Platform

Study Overview
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Brief Summary
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Non-pharmacological interventions and person-centered care strategies are important elements of care for people with Alzheimer's disease and related dementias. Life story work, which uses written and oral life histories to elicit conversation and memories, is an effective intervention for individuals with dementia; however, because of the time-consuming nature of generating useful life story materials, has not been widely implemented in nursing homes and other care environments. LifeBio Inc. will develop an easy-to-use reminiscence therapy platform - LifeBio MemoryTM - with a novel machine-learning-based application that converts speech to text and generates life stories to serve as an interactive tool to cultivate communication between people living with dementia and their family and caregivers.

Detailed Description
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This project offers the unique and timely opportunity to evaluate the feasibility, acceptability, and efficacy of LifeBio Memory's effectiveness as a solution for improving quality of life and quality of care for older adults in long-term care settings, as well as relationships with staff caregivers. This project will implement the the newly developed LifeBio Memory platform and train caregivers in X sites across the state of Ohio, with X residents and X staff participating in a feasibility trial. The program will be evaluated using three waves of data collection from staff during training and throughout implementation, as well as pre-post resident data to evaluate the effectiveness of the new intervention. The LifeBio Memory platform addresses the need for an intuitive, artificial intelligence-driven solution to the traditionally labor-intensive process of collecting, sharing, and celebrating the life stories of older adults, as well as the development of tools for staff caregivers to enhance person-centered care practices and care-planning. It has great potential for improving psychosocial outcomes for participants, enhancing relationships between care staff and residents, and a cost-effective way to identify ways in which life stories can be used to provide a foundation for preference-based, personalized care. Residents will be interviewed at baseline, then again at follow-up (4 weeks later), staff members being trained to utilize the LifeBio Memory application and provide feedback on the materials, as well as completed a survey at baseline, again at follow-up

Official Title
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Development of a Reminiscence Therapy Online Platform With Machine Learning to Increase Engagement With People Living With Dementia and Their Care Partners

Conditions
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Dementia, Cognitive Impairment

Intervention / Treatment
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* Other: LifeBio Memory


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Staff): Work within a residential care facility participating in the study Speak and read English Able to provide own transportation to and from interviews with residents Inclusion Criteria (Residents Must reside within a participating residential care facility Must be at least 55 years of Age Must speak and read English Have a Dementia diagnosis Have a Score of at least 15 on the Mini Mental State Examination Exclusion Criteria (Residents) Residents will be excluded from the study if they show signs of rapid cognitive decline or physical deterioration over the last 6 months, as evidence by information gained during screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 112 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Staff<br>Staff will be trained in the platform, and complete life story interviews with residents at their facilities. Upon completion of training, staff will complete surveys regarding it's effectiveness and utility, and following the completion of the interview, the resident's life story books, summary materials, and staff tools will be delivered four weeks later. Life story materials are meant to assist staff in providing more personalized care and a mechanism for residents to feel more deeply understood. | Other: LifeBio Memory<br>* LifeBio Memory is a digital reminiscence therapy platform designed to collect the life stories of older adults to generate personalized life storybooks that capture their unique narratives and social histories. Life story booklets, summaries, and materials are also developed as mechanisms for sharing this story and for staff to provide enhanced person-centered care.<br>|
| Experimental: Residents<br>Residents will be screened for their cognitive status and compete interviews with a researcher prior to participation in the life story interview. Residents will then be interviewed again at T3 about four weeks after the life story books, summaries, and staff materials have been delivered. | Other: LifeBio Memory<br>* LifeBio Memory is a digital reminiscence therapy platform designed to collect the life stories of older adults to generate personalized life storybooks that capture their unique narratives and social histories. Life story booklets, summaries, and materials are also developed as mechanisms for sharing this story and for staff to provide enhanced person-centered care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Center for Epidemiological Studies Depression Scale (CES-D) from Baseline | Measure of depressive symptomatology; Scale: 0 (rarely or none of the time) to 3 (most or almost all of the time) | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Satisfaction with Care in the Nursing Home Scale from Baseline | Measurement of resident satisfaction with care in a long-term care facility | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Quality of Life Alzheimer's Disease (QoL-AD) from Baseline | Quality of life for an individual living with Alzheimer's Disease: Scale: 1 (poor) to 4 (excellent) | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Cohen-Mansfield Agitation Inventory (CMAI) - Short Form from Baseline | Measurement of agitation; Scale: 1 (never) to 7 (several times an hour) | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Attitudes towards Residents Scale from Baseline | Measurement of the attitudes of staff long term care staff towards the residents under their care | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Individualized Care Instrument (ICI) from Baseline | Measurement of care recipient perceptions of individualized nursing care; Scale: 1 (strongly disagree) to 4 (strongly agree) | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in The UCLA 3-Item Loneliness Scale from Baseline | Measurement of feelings of loneliness; Scale: 0 (hardly ever) to 2 (often) | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Resident Satisfaction with Care [Modified version of the Ohio Nursing Home Resident Satisfaction Survey] from Baseline | Measurement of care satisfaction; Scale: 1 (generally yes) to 2 (generally no) | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Perceived Usefulness of LifeBio Memory from Baseline | Items related to staff perceived usefulness of the LifeBio Memory program | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Satisfaction with LifeBio Memory | Items related to overall satisfaction with the LifeBio Memory program | After intervention (4 weeks from baseline) | 
| Change in Sense of Competence in Dementia Care Staff (SCIDS) Scale from Baseline | Measurement of sense of dementia care competence; Scale: 0 (very much) to 3 (not at all) | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Person-Centered Care Assessment Tool [Sub-Scales I and II] from Baseline | Measurement of staff experience with person-centered care in their current care community; Scale: 0 (strongly agree) to 4 (strongly disagree) | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Direct Care Worker Job Satisfaction Scale from Baseline | Measurement of staff satisfaction with different aspects of their job; Scale: 0 (very dissatisfied) to 3 (very satisfied) | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Adherence to LifeBio Memory Treatment Protocol | Items related to staff adherence to LifeBio Memory program protocols | After intervention (4 weeks from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mini Mental Status Examination (MMSE) from Baseline | Screening for resident cognitive status | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Adequate Knowledge of Care Preferences from Baseline | Items related to staff knowledge of resident care preferences | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Change in Understanding of Resident's Life Story from Baseline | Items related to staff understanding of resident life stories | Baseline, pre-intervention; After intervention (4 weeks from baseline) | 
| Length of Life Story Interview | Items related to the amount of time spent doing the life story interview | After intervention (4 weeks from baseline) |