LifeBio Memory Digital Reminiscence Platform

NCT04769466 | Completed Results DMC

• 2 other identifiers: 1908-2161R44AG069566-01
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Cognitive Impairment

Outcome Measures

Primary Outcomes (17)

• Change in Center for Epidemiological Studies Depression Scale (CES-D) From Baseline

  10-item Measure of depressive symptomatology; Scale: 0 (rarely or none of the time) to 3 (most or almost all of the time); Possible scores range from 0 (minimum) to 30 (maximum). Higher scores indicate higher frequency of reported depressive symptomology.

  Baseline, 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; 8-items measured on a scale of 1 = generally yes and 0 = generally no; Possible scores range from 0 (minimum) to 8 (maximum). Higher scores indicate higher satisfaction with care at the resident's facility.

  Baseline; After intervention (4 weeks from baseline)

• Change in Quality of Life Alzheimer's Disease (QoL-AD) From Baseline

  13-item Quality of life scale for an individual living with Alzheimer's Disease: rated on a scale of 1 (poor) to 4 (excellent); Possible scores range from 13 (minimum) to 52 (maximum). Higher scores indicate higher quality of life.

  Baseline; After intervention (4 weeks from baseline)

• Change in Cohen-Mansfield Agitation Inventory (CMAI) - Short Form From Baseline

  14-item Measurement of agitation that was completed by the staff for each resident they were assigned to conduct a life story interview with at baseline and post-intervention (proxy completed by staff on behalf of each resident) rated on a scale: 1 (never) to 5 (several times an hour) scores can range from 14-70, with higher scores indicating higher frequency of agitated behaviors of persons living with dementia as reported by those staff conducting their life story interviews.

  Baseline; After intervention (4 weeks from baseline)

• Change in Staff Attitudes Towards Residents Scale From Baseline

  Measurement of the attitudes of long term care staff towards the residents under their care includes 4-items on a 5-pt scale of 1= never to 5=always, scores ranging from 4 to 20, higher scores indicate more positive attitudes toward residents.

  Baseline; After intervention (4 weeks from baseline)

• Change in Individualized Care Instrument (ICI) Subscale - Knowing the Person - From Baseline

  13-item subscale of the ICI scale "knowing the person"; rated on a scale from 1 (strongly disagree) to 4 (strongly agree); Possible scores range from 13 (minimum) to 52 (maximum). Higher scores indicate staff feel they know the resident more.

  Baseline; After intervention (4 weeks from baseline)

• Change in The UCLA 3-Item Loneliness Scale From Baseline

  3-item Measurement of feelings of loneliness; rated on a scale: 1 (hardly ever) to 3 (often), ranging from 3 to 9, higher scores indicate higher feelings of loneliness.

  Baseline; After intervention (4 weeks from baseline)

• Resident Satisfaction With the LifeBio Memory Program

  A total of 9-items were developed from the pilot and current study to understand resident's acceptance and satisfaction with the LifeBio Memory program. Participants answered either "no" (0) or "yes" (1) to each item, with total scores ranging from 0 to 9 (higher scores indicating high satisfaction with the LifeBio Memory program).

  After intervention (4 weeks from baseline)

• Change in Perceived Importance of Life Story Work Among Staff

  3-item measure related to the importance of life story work with residents; items are rated on a scale from 1 = strongly disagree to 5 = strongly agree, scores ranging from 3 to 15, with higher scores indicating staff feeling life story work is more important.

  Baseline; After intervention (4 weeks from baseline)

• Staff Satisfaction With LifeBio Memory Program

  On the follow-up post-evaluations, staff were asked to rate their overall satisfaction with the LifeBio Memory program. A total of 8-items developed from the pilot and current study were rated on a 1 (strongly disagree) to 5 (strongly agree) scale. Possible scores range from 8 (minimum) to 40 (maximum). Higher scores indicate higher satisfaction with the program.

  After intervention (4 weeks from baseline)

• Change in Sense of Competence in Dementia Care Staff (SCIDS) Scale From Baseline

  17-item measurement of staffs' overall sense of dementia care competence; rated on a scale: 1 (not at all) to 4 (very much) with scores potentially ranging from 17-68, higher scores indicating higher sense of competence in dementia care among staff.

  Baseline; After intervention (4 weeks from baseline)

• Change in Person-Centered Care Assessment Tool [Sub-Scales I and II] From Baseline

  10-item measurement of staff experience with person-centered care in their current care community; rated on a scale: 1 (strongly disagree) to 5 (strongly agree), scores ranging from 10-50, higher scores indicating higher agreement with experience providing person-centered care.

  Baseline; After intervention (4 weeks from baseline)

• Change in Direct Care Worker Job Satisfaction Scale From Baseline

  9-item measurement of staff satisfaction with different aspects of their job; rated on a Scale: 1 (very dissatisfied) to 4 (very satisfied), potential scores ranging from 9-36, higher scores indicating higher satisfaction with their job.

  Baseline; After intervention (4 weeks from baseline)

• Change in Individualized Care Instrument (ICI) Subscale - Resident Autonomy Subscale - From Baseline

  15-item Measurement of staff perceptions about resident's autonomy; rated on a Scale: 1 (never) to 5 (very frequently), potential scores ranging from 15-75, higher scores indicating staff perceiving residents having more frequent autonomy.

  Baseline; After intervention (4 weeks from baseline)

• Change in Individualized Care Instrument (ICI) Subscale - Staff and Resident Communication Subscale - From Baseline

  7-item measurement of staff perceptions of their communication with residents; rated on a Scale: 1 (never) to 4 (always), scores ranging from 7-28. higher scores indicating higher frequency of staff to resident communication about their care.

  Baseline; After intervention (4 weeks from baseline)

• Change in Individualized Care Instrument (ICI) Subscale - Staff to Staff Communication Subscale - From Baseline

  10-item measurement of staff perceptions of staff to staff level communication, rated on a scale from 1 (never) to 4 (always), scores ranging from 10-40, higher scores indicating more frequent staff to staff communication.

  Baseline; After intervention (4 weeks from baseline)

• Staff Perceptions About the Feasibility of the LifeBio Memory Program Protocol

  7-items were developed (rated on a 1 = strongly disagree to 5 = strongly agree response scale) and administered on the follow-up post-evaluation to understand staff's perceptions about the feasibility of the program protocol once interviews were complete and materials (i.e., Action Plans, Life Story books, Snapshots) were delivered (e.g., Within the first 2-weeks of delivery, I was able to present the residents' Action Plans during a team meeting"). Possible scores range from 7 (minimum) to 35 (maximum). Higher scores indicate higher feasibility with the implementation of program materials.

  After intervention (4 weeks from baseline)

Secondary Outcomes (3)

• Change in Mini Mental Status Examination (MMSE) From Baseline

  Baseline; After intervention (4 weeks from baseline)

• Change in Staff Adequate Knowledge of Residents' Care Preferences From Baseline

  Baseline; After intervention (4 weeks from baseline)

• Change in Staff Adequate Knowledge of Residents' Life Stories From Baseline

  Baseline; After intervention (4 weeks from baseline)

Other Outcomes (4)

• Length of Time Staff Spent on LifeBio Memory Training

  Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.

• Preparedness Of Staff Conducting Life Story Interviews

  Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.

• Staff Training Needs Being Met With LifeBio Memory Training

  Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.

Study Arms (2)

Staff

EXPERIMENTAL

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

Residents

EXPERIMENTAL

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

Interventions

LifeBio Memory OTHER

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.

Residents; Staff

Eligibility Criteria

• Age: 18 Years - 112 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benjamin Rose Institute on Aging: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Benjamin Rose Institute on Aging

Cleveland, Ohio, 44120, United States

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Lisbeth Sanders
• Organization: LifeBio

beth@lifebio.com

937-303-4574

Study Officials

• Silvia Orsulic-Jeras, MA

  Benjamin Rose Institute on Aging

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: February 24, 2021
• Study Start: March 22, 2022
• Primary Completion: March 20, 2024
• Study Completion: April 30, 2024
• Last Updated: October 24, 2025
• Results First Posted: October 24, 2025

Record last verified: 2025-08

Locations

US (1)