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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Dementia

Treatments: Other: Usual Care; Other: Health System-based Dementia Care; Other: Community-based Dementia Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03786471

PCS-2017C1-6534 (Other Grant/Funding Number)

IRB 18-001796

R01AG061078-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,176 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,176 participants in 3 patient groups

Health Systems-Based Dementia Care

Active Comparator group

Description:

Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program.

Treatment:

Other: Health System-based Dementia Care

Community-Based Dementia Care

Active Comparator group

Description:

Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program.

Treatment:

Other: Community-based Dementia Care

Usual Care

Other group

Description:

Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services.

Treatment:

Other: Usual Care