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Clinical Trials/NCT04769466
NCT04769466
Completed
N/A

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

Benjamin Rose Institute on Aging1 site in 1 country234 target enrollmentMarch 22, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dementia
Sponsor
Benjamin Rose Institute on Aging
Enrollment
234
Locations
1
Primary Endpoint
Change in Center for Epidemiological Studies Depression Scale (CES-D) From Baseline
Status
Completed
Last Updated
6 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 22, 2022
End Date
April 30, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: Baseline, After intervention (4 weeks 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.

Change in Satisfaction With Care in the Nursing Home Scale From Baseline

Time Frame: Baseline; After intervention (4 weeks 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.

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.

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

Time Frame: Baseline; After intervention (4 weeks 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.

Change in Staff Attitudes Towards Residents Scale From Baseline

Time Frame: Baseline; After intervention (4 weeks 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.

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

Time Frame: Baseline; After intervention (4 weeks 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.

Change in The UCLA 3-Item Loneliness Scale From Baseline

Time Frame: Baseline; After intervention (4 weeks 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.

Resident Satisfaction With the LifeBio Memory Program

Time Frame: After intervention (4 weeks from baseline)

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).

Change in Perceived Importance of Life Story Work Among Staff

Time Frame: Baseline; After intervention (4 weeks from baseline)

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.

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.

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

Time Frame: Baseline; After intervention (4 weeks 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.

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

Time Frame: Baseline; After intervention (4 weeks 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.

Change in Direct Care Worker Job Satisfaction Scale From Baseline

Time Frame: Baseline; After intervention (4 weeks 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.

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

Time Frame: Baseline; After intervention (4 weeks 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.

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

Time Frame: Baseline; After intervention (4 weeks 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.

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

Time Frame: Baseline; After intervention (4 weeks 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.

Staff Perceptions About the Feasibility of the LifeBio Memory Program Protocol

Time Frame: After intervention (4 weeks from baseline)

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.

Secondary Outcomes

  • Change in Staff Adequate Knowledge of Residents' Care Preferences From Baseline(Baseline; After intervention (4 weeks from baseline))
  • Change in Mini Mental Status Examination (MMSE) 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))

Study Sites (1)

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