- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04769466
LifeBio Memory Digital Reminiscence Platform
Development of a Reminiscence Therapy Online Platform With Machine Learning to Increase Engagement With People Living With Dementia and Their Care Partners
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44120
- Benjamin Rose Institute on Aging
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Center for Epidemiological Studies Depression Scale (CES-D) From Baseline
Time Frame: Baseline, After intervention (4 weeks from baseline)
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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.
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Baseline, After intervention (4 weeks from baseline)
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Change in Satisfaction With Care in the Nursing Home Scale From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Change in Quality of Life Alzheimer's Disease (QoL-AD) From Baseline
Time Frame: Baseline; After intervention (4 weeks 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.
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Baseline; After intervention (4 weeks from baseline)
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Change in Cohen-Mansfield Agitation Inventory (CMAI) - Short Form From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Change in Staff Attitudes Towards Residents Scale From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Change in Individualized Care Instrument (ICI) Subscale - Knowing the Person - From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Change in The UCLA 3-Item Loneliness Scale From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Resident Satisfaction With the LifeBio Memory Program
Time Frame: After intervention (4 weeks from baseline)
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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).
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After intervention (4 weeks from baseline)
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Change in Perceived Importance of Life Story Work Among Staff
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Staff Satisfaction With LifeBio Memory Program
Time Frame: After intervention (4 weeks from baseline)
|
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.
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After intervention (4 weeks from baseline)
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Change in Sense of Competence in Dementia Care Staff (SCIDS) Scale From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Change in Person-Centered Care Assessment Tool [Sub-Scales I and II] From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Change in Direct Care Worker Job Satisfaction Scale From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Change in Individualized Care Instrument (ICI) Subscale - Resident Autonomy Subscale - From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Change in Individualized Care Instrument (ICI) Subscale - Staff and Resident Communication Subscale - From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Change in Individualized Care Instrument (ICI) Subscale - Staff to Staff Communication Subscale - From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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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.
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Baseline; After intervention (4 weeks from baseline)
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Staff Perceptions About the Feasibility of the LifeBio Memory Program Protocol
Time Frame: After intervention (4 weeks from baseline)
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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.
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After intervention (4 weeks from baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mini Mental Status Examination (MMSE) From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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Screening for resident cognitive status, scores can range from 0-30, lower scores indicate more cognitive impairment (higher scores indicate less cognitive impairment).
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Baseline; After intervention (4 weeks from baseline)
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Change in Staff Adequate Knowledge of Residents' Care Preferences From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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1-item asked of staff for each resident they interviewed on a scale of 1 = not at all well, to 5 = extremely well ("How well do you know the resident's care preferences?")
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Baseline; After intervention (4 weeks from baseline)
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Change in Staff Adequate Knowledge of Residents' Life Stories From Baseline
Time Frame: Baseline; After intervention (4 weeks from baseline)
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1-item asked of staff for each resident they interviewed on a scale of 1 = not at all well, to 5 = extremely well ("How well do you know the resident's life story?")
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Baseline; After intervention (4 weeks from baseline)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Length of Time Staff Spent on LifeBio Memory Training
Time Frame: Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.
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Item related to staff time spent on LifeBio Memory training
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Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.
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Preparedness Of Staff Conducting Life Story Interviews
Time Frame: Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.
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Staff self-rated preparedness to conduct life story interviews with residents and set up their accounts following training; two 1-item survey questions rated on a scale from 1 = strongly disagree to 6 = strongly agree.
Higher score on each item means stronger agreement towards feelings of being prepared to conduct a life story interview with a person living with dementia using the LifeBio Memory app and setting up their account using the LifeBio Memory app.
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Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.
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Staff Training Needs Being Met With LifeBio Memory Training
Time Frame: Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.
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Staff overall feelings of needs being met with the LifeBio Memory Training Program.
Staff were asked, "Overall, how well does the LifeBio Memory App training meet your needs?"
On a scale from 1 = not well at all to 5 = extremely well.
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Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.
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Staff Objective Knowledge of LifeBio Memory Training Content
Time Frame: Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.
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Staff completed an 11-item quiz post-training (tested on content detailed in the training videos).
It was a multiple choice type quiz, and average score represents total number of correct items on the quiz.
Scores could range from 0 to 11, with the staff ranging from 5-items correct to 11-items answered correctly.
Higher scores indicate higher number of quiz items answered correctly.
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Training was assigned to be completed within one week of baseline. Staff objective knowledge was measured immediately after completing the training videos.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Silvia Orsulic-Jeras, MA, Benjamin Rose Institute on Aging
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1908-216
- 1R44AG069566-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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