100 Participants Needed

Care Coordination System for Dementia

IT
MN
Overseen ByMaria Noun, BS
Age: 65+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Bijan Najafi, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the Care4AD treatment for dementia?

Research on similar care coordination programs, like MIND at Home, shows they can reduce unmet needs and delay the need for more intensive care in people with memory disorders, which suggests that Care4AD might also help manage dementia effectively.12345

Is the Care Coordination System for Dementia safe for humans?

The research does not provide specific safety data for the Care Coordination System for Dementia, but it does not report any safety concerns related to its use in dementia care.16789

How is the Care4AD system treatment different from other dementia treatments?

The Care4AD system is unique because it focuses on improving communication and coordination among care networks for people with dementia, using a digital platform to support caregivers and healthcare providers. This approach emphasizes integrating various health services and community resources to provide comprehensive, patient-centered care, which is different from traditional treatments that may not address these aspects.410111213

What is the purpose of this trial?

Dementia, a chronic disease of aging, is characterized by progressive cognitive decline that interferes with independent functioning. The medical, psychological, social and functional sequelae of dementia cause great stress to patients, their caregivers, and their family. The investigator proposes to examine effectivness of a home-based care coordination and management device, called Care4AD to help caregivers effectively coordinate, manage, and improve dementia care.

Eligibility Criteria

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.
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Group (IG): Care coordination with Care4AD systemExperimental Treatment1 Intervention
All participants will receive Care4AD device.All reminders will be activated in the intervention group (IG). Essential activity daily living (ADL) tasks will be pre-programmed by our care coordination expert for the IG. Patients and their caregivers in the IG will be also able to schedule additional tasks.
Group II: Control Group (CG): Standard of careActive Control1 Intervention
Participants in control group (CG) will also receive Care4AD device. However, all reminders and programming of activity daily living (ADL) tasks will be de-activated in the CG.

Find a Clinic Near You

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+

Findings from Research

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

References

Effect of care coordination on patients with Alzheimer disease and their caregivers. [2021]
Variations in Costs of a Collaborative Care Model for Dementia. [2020]
A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes. [2022]
Health Services Utilization in Older Adults with Dementia Receiving Care Coordination: The MIND at Home Trial. [2019]
A multidimensional home-based care coordination intervention for elders with memory disorders: the maximizing independence at home (MIND) pilot randomized trial. [2022]
Disparities in Preventable Hospitalization Among Patients With Alzheimer Diseases. [2023]
Caring for patients with dementia: how good is the quality of care? Results from three health systems. [2014]
A Multipronged, Adaptive Approach for the Recruitment of Diverse Community-Residing Elders with Memory Impairment: The MIND at Home Experience. [2021]
Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. [2023]
The Dementia Care Coordination Program: Engaging Health Systems in Caregiver Supports. [2019]
11.United Statespubmed.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. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
CASEPLUS-SimPat: An Intersectoral Web-Based Case Management System for Multimorbid Dementia Patients. [2020]
"It made me feel like I wasn't alone in the darkness": exploring dementia care network communication and coordination through a digital health platform. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security