Clinical trial NCT04769466: LifeBio Memory Digital Reminiscence Platform
Official title: Development of a Reminiscence Therapy Online Platform With Machine Learning to Increase Engagement With People Living With Dementia and Their Care Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Cognitive Impairment
Lead sponsor: Benjamin Rose Institute on Aging
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 112
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Center for Epidemiological Studies Depression Scale (CES-D) from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Satisfaction with Care in the Nursing Home Scale from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Quality of Life Alzheimer's Disease (QoL-AD) from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Cohen-Mansfield Agitation Inventory (CMAI) - Short Form from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Attitudes towards Residents Scale from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Individualized Care Instrument (ICI) from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in The UCLA 3-Item Loneliness Scale from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Resident Satisfaction with Care [Modified version of the Ohio Nursing Home Resident Satisfaction Survey] from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Perceived Usefulness of LifeBio Memory from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Satisfaction with LifeBio Memory
timeFrame: After intervention (4 weeks from baseline)
measure: Change in Sense of Competence in Dementia Care Staff (SCIDS) Scale from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Person-Centered Care Assessment Tool [Sub-Scales I and II] from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Direct Care Worker Job Satisfaction Scale from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Adherence to LifeBio Memory Treatment Protocol
timeFrame: After intervention (4 weeks from baseline)
Secondary outcomes:
measure: Change in Mini Mental Status Examination (MMSE) from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Adequate Knowledge of Care Preferences from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Change in Understanding of Resident's Life Story from Baseline
timeFrame: Baseline, pre-intervention; After intervention (4 weeks from baseline)
measure: Length of Life Story Interview
timeFrame: After intervention (4 weeks from baseline)
Other outcomes:
measure: Length of Time Staff Spend on LifeBio Memory Training
timeFrame: Immediately post-training
measure: Level of Staff Difficulty with LifeBio Memory Training
timeFrame: Immediately post-training
measure: Preparedness Of Staff Conducting Life Story Interviews
timeFrame: Immediately post-training
measure: Staff Comfort with LifeBio Memory Protocols
timeFrame: Immediately post-training
measure: Accuracy of LifeBio Memory Technology
timeFrame: Immediately post-training
measure: Staff Perception of LifeBio Memory Training Meeting Program Goals
timeFrame: Immediately post-training
measure: Staff Satisfaction with LifeBio Memory Training
timeFrame: Immediately post-training
Locations:
city: Cleveland
country: United States
facility: Benjamin Rose Institute on Aging
state: Ohio
Study officials:
affiliation: Benjamin Rose Institute on Aging
name: Silvia Orsulic-Jeras, MA
role: PRINCIPAL_INVESTIGATOR
References: