Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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
  • At baseline, the caregiver has cognitive impairment
  • The person with dementia or caregiver is participating in another dementia intervention study

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
2150 dyads of persons with dementia and their respective primary caregiver 1000 in each intervention arm, and 150 in the usual care arm
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Health Systems-Based Dementia Care
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.
  • Other: Health System-based Dementia Care
    Active comparator
Active Comparator
Community-Based Dementia Care
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 or Nurses). 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.
  • Other: Community-based Dementia Care
    Active comparator
Other
Enhanced Usual Care
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 hotline 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.
  • Other: Enhanced Usual Care
    Control

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Roxy Hirst, MS, CCRP
409-266-9641
rmhirst@utmb.edu

More Details

NCT ID
NCT03786471
Status
Recruiting
Sponsor
University of California, Los Angeles

Study Contact

Erin Unger
1-310-312-0531
eunger@mednet.ucla.edu

Detailed 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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.