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Care Coordination System for Dementia

Phase 1 & 2

Recruiting

Research Sponsored by Bijan Najafi, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be ambulatory

Be older than 65 years old

Must not have

Unavailability or unwillingness of the caregiver of the patient to attend the interview.

Major hearing/visual impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a home-based care coordination and management device, called Care4AD, is effective in helping caregivers effectively coordinate, manage, and improve dementia care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since Care4AD is a care coordination system rather than a medication, it doesn't have typical drug side effects. However, there may be challenges related to learning new technology or potential privacy concerns regarding patient information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My caregiver cannot or will not attend the interview.

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I have significant hearing or vision loss.

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I cannot communicate in English or Spanish.

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I cannot move or do daily tasks by myself due to severe health issues.

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I live in a nursing home or am receiving hospice care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in baseline burden and stress of caregivers over 6 months

Cumulative patient adherence to scheduled tasks over 6 months

Secondary study objectives

Mental Depression

Change from baseline cognitive function at 6 months

Change in baseline Physical activity at 6 months

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met