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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months and 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I can walk on my own.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in baseline burden and stress of caregivers over 6 months
Cumulative patient adherence to scheduled tasks over 6 months
Secondary outcome measures
Mental Depression
Change from baseline cognitive function at 6 months
Change in baseline Physical activity at 6 months
+4 more

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BioSensicsIndustry Sponsor
14 Previous Clinical Trials
1,042 Total Patients Enrolled
3 Trials studying Dementia
310 Patients Enrolled for Dementia
Bijan Najafi, PhDLead Sponsor
4 Previous Clinical Trials
234 Total Patients Enrolled
1 Trials studying Dementia
100 Patients Enrolled for Dementia
BioSensics LLCUNKNOWN
4 Previous Clinical Trials
370 Total Patients Enrolled
3 Trials studying Dementia
310 Patients Enrolled for Dementia

Media Library

Care4AD system (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04308512 — Phase 1 & 2
Dementia Research Study Groups: Intervention Group (IG): Care coordination with Care4AD system, Control Group (CG): Standard of care
Dementia Clinical Trial 2023: Care4AD system Highlights & Side Effects. Trial Name: NCT04308512 — Phase 1 & 2
Care4AD system (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04308512 — Phase 1 & 2
Dementia Patient Testimony for trial: Trial Name: NCT04308512 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being sought for this clinical trial?

"That is correct. The trial, which was posted on November 1st 2021 and updated June 23rd 2022, is presently looking for 100 patients from 1 location, according to the data available on clinicaltrials.gov"

Answered by AI

How many people are being given this medication as part of the research?

"Yes, according to the listing on clinicaltrials.gov, this study is currently enrolling patients. This particular trial was first advertised on November 1st, 2021 and was most recently updated on June 23rd, 2022. They are looking for a total of 100 individuals across one site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have trouble remembering words and working out puzzles, and connecting the proper words with the rest of the sentence.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Care Coordination System for People With Dementia
Bijan Najafi, PhD 2021. "Care Coordination System for People With Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04308512.
All > Alzheimer Disease > Dementia
~29 spots leftby May 2025
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