LifeBio Memory Digital Reminiscence Platform

Sponsor
Benjamin Rose Institute on Aging (Other)
Overall Status
Recruiting
CT.gov ID
NCT04769466
Collaborator
(none)
302
Enrollment
1
Location
2
Arms
13.3
Anticipated Duration (Months)
22.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: LifeBio Memory
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
302 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Development of a Reminiscence Therapy Online Platform With Machine Learning to Increase Engagement With People Living With Dementia and Their Care Partners
Actual Study Start Date :
Mar 22, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Staff

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
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.

Experimental: Residents

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
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.

Outcome Measures

Primary Outcome Measures

  1. Change in Center for Epidemiological Studies Depression Scale (CES-D) from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Measure of depressive symptomatology; Scale: 0 (rarely or none of the time) to 3 (most or almost all of the time)

  2. Change in Satisfaction with Care in the Nursing Home Scale from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Measurement of resident satisfaction with care in a long-term care facility

  3. Change in Quality of Life Alzheimer's Disease (QoL-AD) from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Quality of life for an individual living with Alzheimer's Disease: Scale: 1 (poor) to 4 (excellent)

  4. Change in Cohen-Mansfield Agitation Inventory (CMAI) - Short Form from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Measurement of agitation; Scale: 1 (never) to 7 (several times an hour)

  5. Change in Attitudes towards Residents Scale from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Measurement of the attitudes of staff long term care staff towards the residents under their care

  6. Change in Individualized Care Instrument (ICI) from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Measurement of care recipient perceptions of individualized nursing care; Scale: 1 (strongly disagree) to 4 (strongly agree)

  7. Change in The UCLA 3-Item Loneliness Scale from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Measurement of feelings of loneliness; Scale: 0 (hardly ever) to 2 (often)

  8. Change in Resident Satisfaction with Care [Modified version of the Ohio Nursing Home Resident Satisfaction Survey] from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Measurement of care satisfaction; Scale: 1 (generally yes) to 2 (generally no)

  9. Change in Perceived Usefulness of LifeBio Memory from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Items related to staff perceived usefulness of the LifeBio Memory program

  10. Satisfaction with LifeBio Memory [After intervention (4 weeks from baseline)]

    Items related to overall satisfaction with the LifeBio Memory program

  11. Change in Sense of Competence in Dementia Care Staff (SCIDS) Scale from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Measurement of sense of dementia care competence; Scale: 0 (very much) to 3 (not at all)

  12. Change in Person-Centered Care Assessment Tool [Sub-Scales I and II] from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Measurement of staff experience with person-centered care in their current care community; Scale: 0 (strongly agree) to 4 (strongly disagree)

  13. Change in Direct Care Worker Job Satisfaction Scale from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Measurement of staff satisfaction with different aspects of their job; Scale: 0 (very dissatisfied) to 3 (very satisfied)

  14. Adherence to LifeBio Memory Treatment Protocol [After intervention (4 weeks from baseline)]

    Items related to staff adherence to LifeBio Memory program protocols

Secondary Outcome Measures

  1. Change in Mini Mental Status Examination (MMSE) from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Screening for resident cognitive status

  2. Change in Adequate Knowledge of Care Preferences from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Items related to staff knowledge of resident care preferences

  3. Change in Understanding of Resident's Life Story from Baseline [Baseline, pre-intervention; After intervention (4 weeks from baseline)]

    Items related to staff understanding of resident life stories

  4. Length of Life Story Interview [After intervention (4 weeks from baseline)]

    Items related to the amount of time spent doing the life story interview

Other Outcome Measures

  1. Length of Time Staff Spend on LifeBio Memory Training [Immediately post-training]

    Items related to staff time spent on LifeBio Memory training

  2. Level of Staff Difficulty with LifeBio Memory Training [Immediately post-training]

    Staff self-reported difficulty with training sections, content, and materials

  3. Preparedness Of Staff Conducting Life Story Interviews [Immediately post-training]

    Staff self-rated preparedness to conduct life story interviews with residents following training

  4. Staff Comfort with LifeBio Memory Protocols [Immediately post-training]

    Staff self-rated comfort with LifeBio Memory protocols

  5. Accuracy of LifeBio Memory Technology [Immediately post-training]

    The extent to which the technology conveys residents life story accurately

  6. Staff Perception of LifeBio Memory Training Meeting Program Goals [Immediately post-training]

    Staff's perceptions of training meeting the goals of the program

  7. Staff Satisfaction with LifeBio Memory Training [Immediately post-training]

    Staff overall satisfaction with the LifeBio Memory Training Program

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 112 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Benjamin Rose Institute on AgingClevelandOhioUnited States44120

Sponsors and Collaborators

  • Benjamin Rose Institute on Aging

Investigators

  • Principal Investigator: Silvia Orsulic-Jeras, MA, Benjamin Rose Institute on Aging

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Benjamin Rose Institute on Aging
ClinicalTrials.gov Identifier:
NCT04769466
Other Study ID Numbers:
  • 1908-216
First Posted:
Feb 24, 2021
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022