D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care



Status:Not yet recruiting
Conditions:Alzheimer Disease, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:12/27/2018
Start Date:April 1, 2019
End Date:June 30, 2023
Contact:Glen Moulton, MPH MA(Ed)
Email:gmoulton@mednet.ucla.edu
Phone:1-310-312-0531

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Comparative Effectiveness of Health System-based Versus Community-Based Dementia Care / A Pragmatic Clinical Trial of the Effectiveness and Cost-Effectiveness of Dementia Care

D-CARE: The Dementia Care Study

This pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers,
at four diverse clinical trial sites in the United States, will compare the effectiveness and
cost-effectiveness of 18 months of health systems-based dementia care provided by a Dementia
Care Specialist (nurse practitioner or physician assistant) who works within the heath system
versus community-based dementia care provided by a Care Consultant (social worker or nurse)
who works at a Community-Based Organization (CBO).

The trial will also compare the effectiveness and cost-effectiveness of both models versus
enhanced usual care.

D-CARE: The Dementia Care Study

Objective: To determine the comparative effectiveness and cost-effectiveness of two
evidence-based models of comprehensive dementia care, as well as the effectiveness and
cost-effectiveness of both models versus enhanced usual care.

Design: A pragmatic randomized 3-arm superiority trial. The unit of randomization is the
patient/caregiver dyad.

Duration: 6 years. This includes 18 months for recruitment of study participants, 18 months
of interventions/usual care, and simultaneously 18 months of follow-up for research purposes.

Inclusion Criteria:

- The person with dementia has a diagnosis of dementia established by a physician or
other primary care provider

- The person with dementia has a primary care provider who is willing to partner with
the study

- The person with dementia has an unpaid caregiver (family member or friend) who is
willing to participate in the study

- The person resides at home, including assisted living facilities (cannot reside in a
nursing home at the time of recruitment)

- The person with dementia has a caregiver who speaks English or Spanish, and has a
phone

Exclusion Criteria:

- The person with dementia resides in a nursing home at the time of recruitment

- The person with dementia is enrolled in hospice

- The person with dementia plans to move out of the area within the coming year

- The caregiver of the person with dementia is unwilling or anticipates being incapable
of providing self-reported outcome measures for 18 months

- Baseline measures refused or not completed

- The only caregiver willing to participate is paid, and is not a relative or friend of
the person with dementia

- The person with dementia or caregiver is participating in another dementia study
We found this trial at
4
sites
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: Elena Volpi, MD
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Galveston, TX
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Temple, Texas 76504
Principal Investigator: Alan Stevens, PhD
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Temple, TX
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Wilkes-Barre, Pennsylvania 18765
Principal Investigator: Maya Lichtenstein, MD
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Wilkes-Barre, PA
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Winston-Salem, North Carolina 27157
Principal Investigator: Jeffrey Williamson
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Winston-Salem, NC
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