Care Ecosystem for Dementia

No longer recruiting at 5 trial locations

Overseen By Christopher Chow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-progressive dementia, Prior program enrollment, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well the Care Ecosystem program supports people with dementia and their caregivers in real-life settings. The Care Ecosystem provides team-based support via phone and web, aiming to improve life quality, reduce emergency visits, and lower caregiver stress. Participants must have a dementia diagnosis, live at home, and have a main caregiver willing to participate. The trial will assess the program's effectiveness across six different health systems, offering insights into its impact on healthcare and caregiving. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance dementia care for many.

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 healthcare provider.

What prior data suggests that the Care Ecosystem is safe for dementia care?

Research has shown that the Care Ecosystem model is safe for people with dementia and their caregivers. This program provides support from trained Care Team Navigators through phone and online assistance. One study found that participants were highly engaged, with 93% completing surveys at six months and 87% at twelve months, indicating they managed the program well.

The Care Ecosystem has also improved quality of life and reduced emergency visits, with no major safety issues reported. Several health systems already use this model, confirming its safety and effectiveness. Participants in the Care Ecosystem generally receive better care with fewer risks, making it a promising choice for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Care Ecosystem for dementia is unique because it focuses on providing support for both patients and their caregivers, rather than just targeting the patient alone. This approach involves personalized, comprehensive care management and aims to improve the quality of life for those affected by dementia. Unlike traditional treatments that may focus solely on medication management, the Care Ecosystem emphasizes a holistic approach, integrating support systems to address the social, emotional, and medical needs of patients and caregivers. Researchers are excited about this trial because it could lead to a more effective and compassionate way of managing dementia, potentially reducing caregiver burden and enhancing patient well-being.

What evidence suggests that the Care Ecosystem is effective for dementia?

Research has shown that the Care Ecosystem, which participants in this trial will receive, yields promising results for people with dementia. Studies have found that it improves their quality of life and reduces emergency room visits. It also decreases the use of unsuitable medications. Caregivers benefit as well, reporting less depression. This approach employs trained care team navigators to offer support over the phone and online, ensuring easy access and efficiency. Overall, the Care Ecosystem effectively provides better outcomes for those dealing with dementia. ^{1 2 3 6 7}

Who Is on the Research Team?

Katherine L Possin, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with various types of progressive dementia, including Alzheimer's, who live at home and have a primary caregiver willing to participate. They must not be in long-term care facilities, should agree to join the Care Ecosystem program and complete surveys. Those previously enrolled in the program or without accessible health records are excluded.

Inclusion Criteria

My medical records show a dementia diagnosis.

Lives in the community (i.e., not in an assisted living, board & care, skilled nursing or memory care facility) at the time of enrollment

Willingness to enroll in the Care Ecosystem program and complete surveys

Exclusion Criteria

PWD-participants for whom a substantial amount of the patient's healthcare utilization records cannot be accessed for research purposes by the study team

My dementia is stable and caused by a head injury or stroke.

Is currently, or was ever enrolled, in the Care Ecosystem program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Care Ecosystem intervention, which is a remotely delivered team-based dementia care model

12 months

Care delivered via phone and web

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Care Ecosystem

Trial Overview

The study tests the 'Care Ecosystem,' a remote care model delivered by phone and web designed to support patients with dementia and their caregivers. It aims to improve patient quality of life, reduce emergency visits, lower caregiver depression, and cut inappropriate medication use.

How Is the Trial Designed?

Group I: Care Ecosystem Experimental Treatment 1 Intervention

Patient and caregiver dyads receive the Care Ecosystem intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Ochsner Health System

Collaborator

Trials

97

Recruited

91,900+

HealthPartners Institute

Collaborator

Trials

196

Recruited

3,721,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborator

Trials

105

Recruited

46,600+

Providence Health & Services

Collaborator

Trials

131

Recruited

827,000+

Published Research Related to This Trial

Patients with dementia (n = 240) experienced significantly more adverse events during hospitalization, including falls, delirium, and incontinence, compared to those without dementia.

While patients with dementia received more allied health therapies like speech and physiotherapy, they did not show significant functional improvement, highlighting the need for tailored care models to address their unique health care needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events, Functional Decline, and Access to Allied Health Therapies for Patients With Dementia During Acute Hospitalization. Fox, A., MacAndrew, M., Wyles, K., et al.[2021]

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]

In a study of 710 older patients (aged over 70) admitted to a hospital, 8.6% experienced reported adverse events (RAEs), with patient-related incidents linked to factors like male gender, delirium, and cognitive impairment.

Despite the high incidence of RAEs, which occurred at a rate of 2.1 per person year, these events were not associated with increased mortality during the hospital stay, as 11.1% of patients died regardless of RAE occurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events in older people admitted to the acute general hospital: risk factors and the impact of dementia. Watkin, L., Blanchard, MR., Tookman, A., et al.[2021]

Hospital-acquired complications like urinary tract infections, pressure areas, pneumonia, and delirium account for 6.4% of total hospital costs for patients over 50, with dementia patients experiencing these complications at a significantly higher rate (RR 2.5).

These complications lead to an eightfold increase in hospital length of stay and double the average episode cost, highlighting the need for improved care models to prevent such issues, especially in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. Bail, K., Goss, J., Draper, B., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05669365

The Care Ecosystem Consortium Effectiveness Study

The evidence base to date suggests that the Care Ecosystem improves outcomes important to people with dementia, caregivers, and payers when delivered in a ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6777227/

Effect of Collaborative Dementia Care via Telephone and ...

Among active participants, 6-month survey completion rates were 93% for Care Ecosystem and 92% for usual care, and 12-month completion rates were 87% for Care ...

3.

memory.ucsf.edu

memory.ucsf.edu/healthcare-professionals/care-ecosystem

Care Ecosystem - Memory and Aging Center - UCSF

The Care Ecosystem is a model of dementia care designed to provide personalized, cost-efficient care for persons with dementia (PWD) and their caregivers.

4.

jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/fullarticle/2809588

Care Ecosystem Collaborative Model and Health ...

These findings are consistent with results of the Care Ecosystem trial that demonstrated significant treatment effects on patient outcomes ...

5.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.063938

The Care Ecosystem: The Effectiveness and Implementation ...

Compared with usual care, the Care Ecosystem improved PWD quality of life, reduced emergency department visits, reduced the use of potentially ...

6.

chcs.org

chcs.org/care-ecosystem-supporting-dementia-patients-and-their-caregivers-at-home-through-phone-based-guidance-from-care-navigators/

Care Ecosystem: Supporting Dementia Patients and their ...

The randomized controlled trial of the Care Ecosystem program showed improved quality of life for people with dementia, reduced ED visits, and ...

7.

bmcgeriatr.biomedcentral.com

bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-023-04146-z

Implementation and review of the care ecosystem in an ...

Intake forms were developed to collect demographic, baseline, and annual data at one year related to dementia severity and caregiver status.