Care Coordination System for Dementia

Overseen By Maria Noun, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bijan Najafi, PhD

Disqualifiers: Severe dementia, Major impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based device called Care4AD to assist caregivers in managing dementia care. The goal is to determine if the device can simplify life by organizing daily tasks and reminders for individuals with Alzheimer's. Participants will either use the full features of the Care4AD system or the device without additional programming to compare outcomes. The trial seeks older patients with mild or moderate Alzheimer's who live at home with a caregiver and can move independently. As a Phase 1, Phase 2 trial, the research focuses on understanding the device's functionality in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Care4AD system is safe for dementia care?

Research has shown that people find the Care4AD system helpful and easy to use. Users feel comfortable with it, and it appears to cause no harm. Although studies do not provide specific safety details, the device is used at home to coordinate care. This suggests it is likely low-risk, as it does not involve medication or medical procedures. For those considering joining a trial for the Care4AD system, current information indicates that people generally tolerate it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Care4AD system because it offers a new way to manage dementia through enhanced care coordination. Unlike the standard of care, which often relies on unstructured routines and intermittent reminders, Care4AD provides a personalized, pre-programmed system of reminders for essential daily activities. This system could lead to improved daily functioning and reduced caregiver stress by allowing both patients and caregivers to schedule and manage tasks more efficiently. By integrating technology into daily care routines, Care4AD has the potential to transform how we support those living with dementia.

What evidence suggests that the Care4AD system is effective for dementia care?

Research has shown that the Care4AD system greatly assists caregivers in managing dementia care. In this trial, participants in the intervention group will use the Care4AD system with all reminders activated and essential daily living tasks pre-programmed. Caregivers in this group can also schedule additional tasks, which studies have found easy to use and very helpful for organizing care. This system enables caregivers to manage important activities, potentially reducing stress and improving the quality of care for dementia patients. Early results suggest that this tool could significantly impact the daily lives of both patients and their caregivers by simplifying care coordination. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for people over 65 with mild or moderate Alzheimer's Disease who live at home with a caregiver. Participants must be able to walk and communicate in English or Spanish. It's not suitable for those with severe dementia, major medical/psychiatric issues, significant hearing/vision loss, living in nursing homes, receiving hospice care, or without an available caregiver.

Inclusion Criteria

I am over 65 and have mild to moderate Alzheimer's Disease.

Must be in a residential home with a caregiver/informant.

I can walk on my own.

Exclusion Criteria

My caregiver cannot or will not attend the interview.

Any significant medical or psychiatric condition that, in the judgment of the investigators, would potentially interfere with the ability to participate in the study

I have significant hearing or vision loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Care4AD device with activated reminders for the intervention group and deactivated reminders for the control group

6 months

Bi-weekly phone interviews

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Care4AD system

Trial Overview The study is testing the Care4AD system—a device designed to help caregivers coordinate and manage home-based dementia care more effectively. The goal is to see if this tool can improve the quality of life for both patients and their caregivers.

How Is the Trial Designed?

Group I: Intervention Group: Care coordination with active Nili System Active Control 1 Intervention

Participants in the intervention group will receive the Active Nili system. Essential activities of daily living (ADL) were pre-programmed by a care coordination expert for the Active Nili Care Phase. In addition, patients and their caregivers were able to schedule supplementary tasks through the Nili App. All feedback features were fully activated in the Active Nili device.

Group II: Control Group: Receiving passive Nili device Active Control 1 Intervention

Participants in the control group will receive the passive Nili device with preprogrammed care coordination and limited daily programming. However, all reminders and activity of daily living (ADL) task scheduling will remain deactivated during this phase.

Who Is Running the Clinical Trial?

Bijan Najafi, PhD

Lead Sponsor

Trials

5

Recruited

280+

BioSensics

Industry Sponsor

Trials

17

Recruited

1,200+

BioSensics LLC

Collaborator

Trials

5

Recruited

420+

Published Research Related to This Trial

The novel dementia care coordination program did not significantly reduce the use of acute care or inpatient services, but it did lead to an increase in outpatient dementia and mental health visits over 18 months, indicating improved access to specialized care.

Participants in the intervention group significantly increased their use of home and community-based support services, suggesting that the program may help individuals with dementia remain in their homes longer and receive necessary support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Services Utilization in Older Adults with Dementia Receiving Care Coordination: The MIND at Home Trial. Amjad, H., Wong, SK., Roth, DL., et al.[2019]

A multipronged recruitment strategy successfully enrolled 303 diverse participants with memory disorders for an 18-month dementia care coordination trial, highlighting the effectiveness of community partnerships and outreach.

The majority of referrals came from community organizations, particularly benefiting African American/black individuals, indicating that targeted community engagement can enhance participation in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multipronged, Adaptive Approach for the Recruitment of Diverse Community-Residing Elders with Memory Impairment: The MIND at Home Experience. Samus, QM., Amjad, H., Johnston, D., et al.[2021]

The CASEPLUS-SimPat web-based case management system was developed to improve coordination and communication among healthcare professionals caring for dementia patients, addressing the complex needs of these individuals with multimorbidity.

In a pilot test, CASEPLUS-SimPat demonstrated good usability, indicating it could enhance the care process for dementia patients by allowing better access to patient data and facilitating information exchange among caregivers and relatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CASEPLUS-SimPat: An Intersectoral Web-Based Case Management System for Multimorbid Dementia Patients. Steiner, B., Zippel-Schultz, B., Popa, A., et al.[2020]

The Care Ecosystem (CE) program significantly reduced the use of potentially inappropriate medications (PIMs) among 490 community-dwelling individuals living with dementia over a 12-month period, with a notable decrease of 0.35 PIMs per participant compared to usual care.

The CE intervention not only lowered the overall number of PIMs, including anticholinergics, benzodiazepines, and opioids, but also led to more frequent adjustments in anti-dementia medication regimens, indicating an optimization of medication use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. Liu, AK., Possin, KL., Cook, KM., et al.[2023]

Patients with Alzheimer's disease who were treated at hospitals affiliated with accountable care organizations (ACOs) had lower rates of potentially preventable hospitalizations, indicating improved care coordination, with an odds ratio of 0.86 (p=0.02).

The study found that ACO affiliation helped reduce hospitalization disparities between African American and White patients with Alzheimer's, explaining 3.01% of the disparity, but did not address disparities between White and Latinx patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disparities in Preventable Hospitalization Among Patients With Alzheimer Diseases. Chen, J., Benjenk, I., Barath, D., et al.[2023]

In a study of 387 patient-caregiver pairs, adherence to recommended dementia care processes was low, with only 37% adherence for assessment, 33% for treatment, 52% for education and support, and a concerning 21% for safety, indicating significant room for improvement in dementia care quality.

Higher caregiver knowledge was consistently linked to better adherence to care processes, suggesting that enhancing caregiver education could be a key intervention to improve the quality of dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for patients with dementia: how good is the quality of care? Results from three health systems. Chodosh, J., Mittman, BS., Connor, KI., et al.[2014]

The Dementia Care Coordination Program effectively utilizes the medical system to identify and refer families to support services, showing high satisfaction rates among stakeholders, including physicians and caregivers.

The program's health plan model demonstrates significant potential for early detection of clients needing support, although improvements in information sharing and data tracking are necessary for optimal functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dementia Care Coordination Program: Engaging Health Systems in Caregiver Supports. Nadash, P., Silverstein, NM., Porell, F.[2019]

The CareVirtue journal feature was effectively used by care networks of Alzheimer's patients for 60 days, facilitating communication through information sharing, strategy development, and feedback among caregivers.

Primary caregivers found the journal useful at multiple levels, enhancing individual support and strengthening care network relationships, highlighting the importance of caregiver-centered technologies in dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It made me feel like I wasn't alone in the darkness": exploring dementia care network communication and coordination through a digital health platform. Linden, A., Jolliff, A., Gonzalez, D., et al.[2023]

The collaborative dementia care program showed a decrease in implementation costs over time, with costs per participant per month dropping from $581 during start-up to $241 during continuing operations in California, indicating improved efficiency as the program matured.

Caseload size significantly influenced service costs, suggesting that increasing the number of participants per care team navigator can help reduce costs while maintaining quality care, which is crucial for informing future reimbursement policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variations in Costs of a Collaborative Care Model for Dementia. Rosa, TD., Possin, KL., Bernstein, A., et al.[2020]

The MIND at Home intervention, which involved care coordination for caregivers of individuals with memory disorders, did not significantly reduce unmet caregiving needs or burden compared to a control group over 18 months, based on a study of 289 caregiver-care recipient pairs.

However, caregivers in the MIND at Home group reported a potentially meaningful reduction in the number of hours spent caring for the care recipient, suggesting some positive impact on caregiver time management despite no significant changes in overall caregiver burden or quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes. Tanner, JA., Black, BS., Johnston, D., et al.[2022]

The 18-month dementia care coordination intervention significantly delayed the transition from home for elders with memory disorders, reducing the risk of leaving home by 37% compared to control participants.

Participants in the intervention reported improved quality of life and had notable reductions in unmet needs related to safety and legal/advance care, although overall unmet needs did not significantly differ from the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multidimensional home-based care coordination intervention for elders with memory disorders: the maximizing independence at home (MIND) pilot randomized trial. Samus, QM., Johnston, D., Black, BS., et al.[2022]

The care coordination and caregiver support intervention did not reduce overall acute medical service use for patients with Alzheimer disease, but it did lead to increased total charges and inpatient admissions related to Alzheimer's diagnosis.

However, the intervention showed potential benefits by reducing emergency department visits and decreasing acute visits for depression among caregivers, suggesting improved caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of care coordination on patients with Alzheimer disease and their caregivers. Chen, B., Cheng, X., Streetman-Loy, B., et al.[2021]

The UCLA Alzheimer's and Dementia Care program effectively partners with community-based organizations to provide comprehensive, patient-centered care for individuals with dementia, aiming to improve their quality of life and reduce caregiver strain.

Initial results from the first 150 participants indicate that the program's care plans commonly include referrals to support groups and caregiver training, highlighting its focus on holistic support for both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The University of California at Los Angeles Alzheimer's and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. Reuben, DB., Evertson, LC., Wenger, NS., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36096091/

Care4AD: A Technology-Driven Platform for Care ... - PubMed Overall, the results support a high perception of usefulness, ease of use, and attitude towards using Care4AD. The key barriers to adopting such technology ...

2. digitalcommons.library.tmc.edu digitalcommons.library.tmc.edu/cgi/viewcontent.cgi?article=1060&context=aging_research

Care4AD: A Technology-Driven Platform for Care ... 2. Care4AD app: The app would be used by caregivers to plan, coordinate and manage dementia care. It would enable caregiv- ers to easily (1) ...

3. reporter.nih.gov reporter.nih.gov/search/k7oX3HCb6U-S9vHRGaynZg/project-details/10412144

Care4AD Care4AD will consist of four technologies that work in tandem to enable effective care coordination. The Care4AD app will be used by caregivers to coordinate ...

4. karger.com karger.com/ger/article/69/2/227/841767/Care4AD-A-Technology-Driven-Platform-for-Care

Care4AD: A Technology-Driven Platform for Care ... Care4AD app: The app would be used by caregivers to plan, coordinate and manage dementia care. It would enable caregivers to easily (1) assign/ ...

5. researchgate.net researchgate.net/publication/363498396_Care4AD_A_Technology-Driven_Platform_for_Care_Coordination_and_Management_Acceptability_Study_in_Dementia

Care4AD: A Technology-Driven Platform for Care ... This study aims to assess the acceptability and feasibility of a technology-driven platform to facilitate care coordination platform, Care4AD, from the end-user ...

6. reporter.nih.gov reporter.nih.gov/project-details/10412144

Project Details We propose to develop a home-based care coordination and management platform to help caregivers effectively coordinate, manage, and improve dementia care.