LifeBio Memory Digital Reminiscence Platform

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04769466
• Other study ID #: 1908-216
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: Benjamin Rose Institute on Aging
• Contact: Silvia Orsulic-Jeras, MA
• Phone: (216) 373-1625
• Email: sjeras[@]benrose.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 112 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Dementia

Intervention

Other:
• LifeBio Memory
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.

Locations

Country	Name	City	State
United States	Benjamin Rose Institute on Aging	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Benjamin Rose Institute on Aging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Time Staff Spend on LifeBio Memory Training	Items related to staff time spent on LifeBio Memory training	Immediately post-training
Other	Level of Staff Difficulty with LifeBio Memory Training	Staff self-reported difficulty with training sections, content, and materials	Immediately post-training
Other	Preparedness Of Staff Conducting Life Story Interviews	Staff self-rated preparedness to conduct life story interviews with residents following training	Immediately post-training
Other	Staff Comfort with LifeBio Memory Protocols	Staff self-rated comfort with LifeBio Memory protocols	Immediately post-training
Other	Accuracy of LifeBio Memory Technology	The extent to which the technology conveys residents life story accurately	Immediately post-training
Other	Staff Perception of LifeBio Memory Training Meeting Program Goals	Staff's perceptions of training meeting the goals of the program	Immediately post-training
Other	Staff Satisfaction with LifeBio Memory Training	Staff overall satisfaction with the LifeBio Memory Training Program	Immediately post-training
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Satisfaction with LifeBio Memory	Items related to overall satisfaction with the LifeBio Memory program	After intervention (4 weeks from baseline)
Primary	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)
Primary	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)
Primary	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)
Primary	Adherence to LifeBio Memory Treatment Protocol	Items related to staff adherence to LifeBio Memory program protocols	After intervention (4 weeks from baseline)
Secondary	Change in Mini Mental Status Examination (MMSE) from Baseline	Screening for resident cognitive status	Baseline, pre-intervention; After intervention (4 weeks from baseline)
Secondary	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)
Secondary	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)
Secondary	Length of Life Story Interview	Items related to the amount of time spent doing the life story interview	After intervention (4 weeks from baseline)