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Dementia Care Training for Dementia (CfAA Trial)

N/A
Waitlist Available
Led By Olivia I Okereke, MD, MS
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mild cognitive impairment or dementia diagnosis of no greater than mild-moderate severity
Age 60 years and above
Must not have
Discharge to Medicare short-term rehab only
University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) score below cutoff
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if improved training for home health aides can reduce behavioral symptoms and improve life quality for people with dementia and their care partners.

Who is the study for?
This trial is for individuals aged 60 or above with mild to moderate dementia or cognitive impairment, who are part of the Mass General Brigham healthcare system and have a care partner. They must be referred to home care services after hospital discharge and able to read English. Those with severe dementia, without a care partner, in palliative care, or unable to consent due to cognitive issues cannot participate.
What is being tested?
The study tests if special training for home health aides on how to handle dementia can improve behavior symptoms in older adults with dementia/cognitive impairment and enhance life quality for them and their caregivers. Participants will be randomly assigned into groups receiving either enhanced training or standard practices.
What are the potential side effects?
Since this intervention involves educational training rather than medication, traditional side effects are not expected. However, there may be indirect effects on patients' well-being based on changes in caregiver behavior following the training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cognitive issues are mild to moderate.
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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am being discharged to a Medicare-approved short-term rehab.
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My UBACC score indicates I might struggle to understand complex medical information.
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My dementia is moderate or severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, 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
Neuropsychiatric Inventory-Questionnaire
Patient-Reported Outcomes Measurement Information System Global Health, 10-item

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: Home Health Aides with Enhanced Curriculum TrainingExperimental Treatment1 Intervention
The enhanced curriculum of 108 hours of home health aide (HHA) training will constitute the Experimental arm. This arm consists of the 100 hours of the standard curriculum plus an 8-hour enhanced curriculum that includes additional didactic content and a skills practicum on dementia and recognizing and responding to dementia-related behaviors. As with the standard curriculum, the enhanced curriculum will be delivered by the training entity, CCHERS (Center for Community Health Education, Research and Service, Inc.). The enhanced component is delivered over an additional 2 instructional days (10% increase in instructional days from the standard curriculum).
Group II: Home Health Aides with Standard Curriculum TrainingActive Control1 Intervention
The standard curriculum of 100 hours of home health aide (HHA) training will constitute the No Intervention arm. This 100-hour training is the standard curriculum that has been used by the training entity, CCHERS (Center for Community Health Education, Research and Service, Inc.), for many years to qualify HHAs to receive certificates from the Massachusetts Home Care Aide Council. The standard curriculum includes 75 hours of basic instruction ("ABC's for Direct Care Workers") and 25 hours of additional content on mental health and dementia topics. The standard curriculum is delivered over approximately on month, or 20 instructional days.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,309,211 Total Patients Enrolled
Olivia I Okereke, MD, MSPrincipal InvestigatorMassachusetts General Hospital
Olivia I OkerekePrincipal InvestigatorMassachusetts General Hospital
~80 spots leftby Sep 2026