DementiaNCT04769466
LifeBio Memory Digital Reminiscence Platform
A study testing LifeBio Memory in people with Dementia and Cognitive Impairment, run by Benjamin Rose Institute on Aging at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 112 years
- Conditions the study is for
- Dementia, Cognitive Impairment
- What is being tested?
- LifeBio Memory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 112 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Benjamin Rose Institute on Aging
Cleveland, Ohio, 44120
About this study
Official title: Development of a Reminiscence Therapy Online Platform With Machine Learning to Increase Engagement With People Living With Dementia and Their Care Partners
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.
Read the 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
- Conditions
- Dementia, Cognitive Impairment
- Being tested
- LifeBio Memory
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeBio MemoryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: LifeBio Memory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After intervention (4 weeks from baseline)
Secondary outcomes (3)
Change in Mini Mental Status Examination (MMSE) From Baseline
Screening for resident cognitive status, scores can range from 0-30, lower scores indicate more cognitive impairment (higher scores indicate less cognitive impairment).
Measured: Baseline; After intervention (4 weeks from baseline)
Change in Staff Adequate Knowledge of Residents' Care Preferences From Baseline
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?")
Measured: Baseline; After intervention (4 weeks from baseline)
Change in Staff Adequate Knowledge of Residents' Life Stories From Baseline
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?")
Measured: Baseline; After intervention (4 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start22 Mar 2022
- Primary completion20 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benjamin Rose Institute on Aging
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Silvia Orsulic-Jeras, MA, Principal investigator, Benjamin Rose Institute on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769466
- Sponsor's protocol ID
- 1908-216
- Other IDs
- 1R44AG069566-01
- Status last verified
- Aug 2025
- First submitted
- 28 Sep 2020
- Last updated
- 24 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Reminiscence Therapy Online Platform With Machine Learning to Increase Engagement With People Living With Dementia and Their Care Partners
- ClinicalTrials.gov ID
- NCT04769466
- Acronym / sponsor ID
- 1908-216
- Conditions
- Dementia, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Benjamin Rose Institute on AgingUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staff | Experimental | Other: LifeBio MemoryStaff 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 | Experimental | Other: LifeBio MemoryResidents 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. |
Who may qualify
- Ages
- 18 to 112 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifeBio MemoryLifeBio 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. | Other | Residents, Staff |
Primary outcome
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.
3 secondary outcomes
Change in Mini Mental Status Examination (MMSE) From Baseline
Time frame: Baseline; After intervention (4 weeks from baseline)
Change in Staff Adequate Knowledge of Residents' Care Preferences From Baseline
Time frame: Baseline; After intervention (4 weeks from baseline)
Change in Staff Adequate Knowledge of Residents' Life Stories From Baseline
Time frame: Baseline; After intervention (4 weeks from baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Orsulic-Jeras, MA principal investigator
Benjamin Rose Institute on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeBio Memory in people with Dementia and Cognitive Impairment, run by Benjamin Rose Institute on Aging at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Center for Epidemiological Studies Depression Scale (CES-D) From Baseline (time frame: Baseline, After intervention (4 weeks from baseline)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.