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

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, compares 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, nurse, or therapist) who works at a Community-Based Organization (CBO).

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

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

Duration: 6.5 years. This includes 34 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 a caregiver who speaks English or Spanish, and has a phone
• Persons living with dementia in assisted living facilities will be eligible if they do not meet any exclusion criteria (however, no more than 25% of participants can be living in assisted living facilities at the time of enrollment. This will be monitored when the first 25% of the sample has been enrolled.)

Exclusion Criteria:

• The person with dementia resides in a nursing home at the time of recruitment
• The person with dementia is enrolled in hospice at the time of screen
• 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 caregiver is paid, and is not a relative or close friend of the person with dementia
• At telephone or in-person screener, the caregiver has cognitive impairment
• The person with dementia or caregiver is participating in another dementia intervention study
• Patients and caregivers who are members of a sites' Local Patient & Stakeholder Committee
• There is already a member of the same household participating in the study.