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LifeBio Memory Digital Reminiscence Platform

Primary Purpose

Dementia, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LifeBio Memory
Sponsored by
Benjamin Rose Institute on Aging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

18 Years - 112 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Benjamin Rose Institute on AgingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Staff

Residents

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
Change in Satisfaction with Care in the Nursing Home Scale from Baseline
Measurement of resident satisfaction with care in a long-term care facility
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)
Change in Cohen-Mansfield Agitation Inventory (CMAI) - Short Form from Baseline
Measurement of agitation; Scale: 1 (never) to 7 (several times an hour)
Change in Attitudes towards Residents Scale from Baseline
Measurement of the attitudes of staff long term care staff towards the residents under their care
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)
Change in The UCLA 3-Item Loneliness Scale from Baseline
Measurement of feelings of loneliness; Scale: 0 (hardly ever) to 2 (often)
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)
Change in Perceived Usefulness of LifeBio Memory from Baseline
Items related to staff perceived usefulness of the LifeBio Memory program
Satisfaction with LifeBio Memory
Items related to overall satisfaction with the LifeBio Memory program
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)
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)
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)
Adherence to LifeBio Memory Treatment Protocol
Items related to staff adherence to LifeBio Memory program protocols

Secondary Outcome Measures

Change in Mini Mental Status Examination (MMSE) from Baseline
Screening for resident cognitive status
Change in Adequate Knowledge of Care Preferences from Baseline
Items related to staff knowledge of resident care preferences
Change in Understanding of Resident's Life Story from Baseline
Items related to staff understanding of resident life stories
Length of Life Story Interview
Items related to the amount of time spent doing the life story interview

Full Information

First Posted
September 28, 2020
Last Updated
July 27, 2023
Sponsor
Benjamin Rose Institute on Aging
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1. Study Identification

Unique Protocol Identification Number
NCT04769466
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Benjamin Rose Institute on Aging

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Cognitive Impairment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
302 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Staff
Arm Type
Experimental
Arm Description
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.
Arm Title
Residents
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
LifeBio Memory
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Center for Epidemiological Studies Depression Scale (CES-D) from Baseline
Description
Measure of depressive symptomatology; Scale: 0 (rarely or none of the time) to 3 (most or almost all of the time)
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Satisfaction with Care in the Nursing Home Scale from Baseline
Description
Measurement of resident satisfaction with care in a long-term care facility
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Quality of Life Alzheimer's Disease (QoL-AD) from Baseline
Description
Quality of life for an individual living with Alzheimer's Disease: Scale: 1 (poor) to 4 (excellent)
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Cohen-Mansfield Agitation Inventory (CMAI) - Short Form from Baseline
Description
Measurement of agitation; Scale: 1 (never) to 7 (several times an hour)
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Attitudes towards Residents Scale from Baseline
Description
Measurement of the attitudes of staff long term care staff towards the residents under their care
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Individualized Care Instrument (ICI) from Baseline
Description
Measurement of care recipient perceptions of individualized nursing care; Scale: 1 (strongly disagree) to 4 (strongly agree)
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in The UCLA 3-Item Loneliness Scale from Baseline
Description
Measurement of feelings of loneliness; Scale: 0 (hardly ever) to 2 (often)
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Resident Satisfaction with Care [Modified version of the Ohio Nursing Home Resident Satisfaction Survey] from Baseline
Description
Measurement of care satisfaction; Scale: 1 (generally yes) to 2 (generally no)
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Perceived Usefulness of LifeBio Memory from Baseline
Description
Items related to staff perceived usefulness of the LifeBio Memory program
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Satisfaction with LifeBio Memory
Description
Items related to overall satisfaction with the LifeBio Memory program
Time Frame
After intervention (4 weeks from baseline)
Title
Change in Sense of Competence in Dementia Care Staff (SCIDS) Scale from Baseline
Description
Measurement of sense of dementia care competence; Scale: 0 (very much) to 3 (not at all)
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Person-Centered Care Assessment Tool [Sub-Scales I and II] from Baseline
Description
Measurement of staff experience with person-centered care in their current care community; Scale: 0 (strongly agree) to 4 (strongly disagree)
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Direct Care Worker Job Satisfaction Scale from Baseline
Description
Measurement of staff satisfaction with different aspects of their job; Scale: 0 (very dissatisfied) to 3 (very satisfied)
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Adherence to LifeBio Memory Treatment Protocol
Description
Items related to staff adherence to LifeBio Memory program protocols
Time Frame
After intervention (4 weeks from baseline)
Secondary Outcome Measure Information:
Title
Change in Mini Mental Status Examination (MMSE) from Baseline
Description
Screening for resident cognitive status
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Adequate Knowledge of Care Preferences from Baseline
Description
Items related to staff knowledge of resident care preferences
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Change in Understanding of Resident's Life Story from Baseline
Description
Items related to staff understanding of resident life stories
Time Frame
Baseline, pre-intervention; After intervention (4 weeks from baseline)
Title
Length of Life Story Interview
Description
Items related to the amount of time spent doing the life story interview
Time Frame
After intervention (4 weeks from baseline)
Other Pre-specified Outcome Measures:
Title
Length of Time Staff Spend on LifeBio Memory Training
Description
Items related to staff time spent on LifeBio Memory training
Time Frame
Immediately post-training
Title
Level of Staff Difficulty with LifeBio Memory Training
Description
Staff self-reported difficulty with training sections, content, and materials
Time Frame
Immediately post-training
Title
Preparedness Of Staff Conducting Life Story Interviews
Description
Staff self-rated preparedness to conduct life story interviews with residents following training
Time Frame
Immediately post-training
Title
Staff Comfort with LifeBio Memory Protocols
Description
Staff self-rated comfort with LifeBio Memory protocols
Time Frame
Immediately post-training
Title
Accuracy of LifeBio Memory Technology
Description
The extent to which the technology conveys residents life story accurately
Time Frame
Immediately post-training
Title
Staff Perception of LifeBio Memory Training Meeting Program Goals
Description
Staff's perceptions of training meeting the goals of the program
Time Frame
Immediately post-training
Title
Staff Satisfaction with LifeBio Memory Training
Description
Staff overall satisfaction with the LifeBio Memory Training Program
Time Frame
Immediately post-training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
112 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Orsulic-Jeras, MA
Phone
(216) 373-1625
Email
sjeras@benrose.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lisbeth Sanders
Email
bsanders@lifebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Orsulic-Jeras, MA
Organizational Affiliation
Benjamin Rose Institute on Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benjamin Rose Institute on Aging
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Orsulic-Jeras, MA
Phone
216-373-1625
Email
sjeras@benrose.org
First Name & Middle Initial & Last Name & Degree
Silvia Orsulic-Jeras, MA
First Name & Middle Initial & Last Name & Degree
Lisbeth Sanders, BA
First Name & Middle Initial & Last Name & Degree
Farida Ejaz, PhD
First Name & Middle Initial & Last Name & Degree
Sara Powers, PhD

12. IPD Sharing Statement

Learn more about this trial

LifeBio Memory Digital Reminiscence Platform

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