D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care
NCT ID: NCT03786471
Last Updated: 2025-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2176 participants
INTERVENTIONAL
2019-06-28
2023-08-21
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 1000 in each intervention arm, and 150 in the usual care arm
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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, 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.
Community-based Dementia Care
Active comparator
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 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.
Usual Care
Control
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.
Health System-based Dementia Care
Active comparator
Interventions
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Health System-based Dementia Care
Active comparator
Community-based Dementia Care
Active comparator
Usual Care
Control
Eligibility Criteria
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Inclusion Criteria
* 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 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.
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
National Institute on Aging (NIA)
NIH
Yale University
OTHER
Benjamin Rose Institute on Aging
OTHER
Baylor Scott and White Health
OTHER
Wake Forest University Health Sciences
OTHER
University of Texas
OTHER
Geisinger Clinic
OTHER
University of Oklahoma
OTHER
RAND
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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David B. Reuben, MD
Director, Multicampus Program in Geriatric Medicine & Gerontology; Chief, Division of Geriatrics
Principal Investigators
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David Reuben, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Thomas Gill, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
David Bass, PhD
Role: PRINCIPAL_INVESTIGATOR
Benjamin Rose Institute on Aging
Lee Jennings, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklohoma
Maya Lichtenstein, MD
Role: PRINCIPAL_INVESTIGATOR
Geisinger Clinic
Peter Peduzzi, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Alan Stevens, PhD
Role: PRINCIPAL_INVESTIGATOR
Baylor Scott and White Health
Elena Volpi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Jeffrey Williamson, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Christopher Callahan, MD
Role: STUDY_CHAIR
Indiana University
Katie Maslow, MSW
Role: STUDY_CHAIR
Gerontological Society of America
Jenny Summapund, MA
Role: STUDY_DIRECTOR
University of California, Los Angeles
Locations
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Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Geisinger Health
Wilkes-Barre, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
Baylor Scott & White
Temple, Texas, United States
Countries
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References
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Reuben DB, Stevens AB, Gill TM, Williamson J, Volpi E, Lichtenstein ML, Jennings LA, Galloway R, Summapund J, Araujo K, Bass D, Weitzman L, Tan ZS, Evertson LC, Yang M, Green AS, Samper-Ternent R, Borek P, Xu Y, Peduzzi P, Greene EJ; D-CARE Study. Patient and Caregiver Outcomes of Health System, Community-Based, and Usual Dementia Care: A Prespecified Analysis of the Dementia Care Study (D-CARE) Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 2:e254247. doi: 10.1001/jamainternmed.2025.4247. Online ahead of print.
Reuben DB, Gill TM, Stevens A, Williamson J, Volpi E, Lichtenstein M, Jennings LA, Galloway R, Summapund J, Araujo K, Bass D, Weitzman L, Tan ZS, Evertson L, Yang M, Currie K, Green AS, Godoy S, Abraham S, Reese J, Samper-Ternent R, Hirst RM, Borek P, Charpentier P, Meng C, Dziura J, Xu Y, Skokos EA, He Z, Aiudi S, Peduzzi P, Greene EJ; D-CARE Study. Health System, Community-Based, or Usual Dementia Care for Persons With Dementia and Caregivers: The D-CARE Randomized Clinical Trial. JAMA. 2025 Mar 18;333(11):950-961. doi: 10.1001/jama.2024.25056.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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PCS-2017C1-6534
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB 18-001796
Identifier Type: -
Identifier Source: org_study_id
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