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