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

NCT03786471 | Completed Results DMC

• 3 other identifiers: IRB 18-001796R01AG061078-01PCS-2017C1-6534
• Study Type: interventional
• Target: 2,176
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Dementia

Keywords

dementia; pragmatic clinical trial; effectiveness; cost-effectiveness; Alzheimer's disease

Outcome Measures

Primary Outcomes (14)

• Severity of Dementia-related Behavioral Symptoms

  The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at baseline.

  Baseline

• Severity of Dementia-related Behavioral Symptoms

  The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 3 month.

  3-month

• Severity of Dementia-related Behavioral Symptoms

  The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 6 months.

  6-month

• Severity of Dementia-related Behavioral Symptoms

  The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 12 months.

  12-month

• Severity of Dementia-related Behavioral Symptoms

  The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 18 months.

  18-month

• Severity of Dementia-related Behavioral Symptoms (Common Baseline)

  The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the least squares mean of the baseline "treatment 0", which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.

  Baseline

• Severity of Dementia-related Behavioral Symptoms

  The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents those average least squares means across all follow-up times for each arm.

  Average of 3M, 6M, 12M, and 18M least square means.

• Caregiver Distress/Strain

  The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at baseline.

  Baseline

• Caregiver Distress/Strain

  The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 3 months.

  3-month

• Caregiver Distress/Strain

  The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 6 months.

  6-month

• Caregiver Distress/Strain

  The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 12 months.

  12-month

• Caregiver Distress/Strain

  The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 18 months.

  18-month

• Caregiver Distress/Strain (Common Baseline)

  The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the least squares mean of the baseline "treatment 0", which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.

  Baseline

• Caregiver Distress/Strain

  The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents those average least squares means across all follow-up times for each arm.

  Average of 3M, 6M, 12M, and 18M least square means

Secondary Outcomes (19)

• Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms

  Baseline

• Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms

  3-month

• Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms

  6-month

• Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms

  12-month

• Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms

  18-month

Other Outcomes (22)

• Cognition of Persons Living With Dementia

  Baseline

• Cognition of Persons Living With Dementia (Missing Data)

  Baseline

• Functional Status Measured by FAQ

  Baseline

Study Arms (3)

Health Systems-Based Dementia Care

ACTIVE COMPARATOR

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

Community-Based Dementia Care

ACTIVE COMPARATOR

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.

Other: Community-based Dementia Care

Usual Care

OTHER

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.

Other: Usual Care

Interventions

Health System-based Dementia Care OTHER

Active comparator

Health Systems-Based Dementia Care

Community-based Dementia Care OTHER

Active comparator

Community-Based Dementia Care

Usual Care OTHER

Control

Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Patient-Centered Outcomes Research Institute: collaborator
• National Institute on Aging (NIA): collaborator
• Yale University: collaborator
• Benjamin Rose Institute on Aging: collaborator
• Baylor Scott and White Health: collaborator
• Wake Forest University Health Sciences: collaborator
• University of Texas: collaborator
• Geisinger Clinic: collaborator
• University of Oklahoma: collaborator
• RAND: collaborator

Study Sites (4)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27109, United States

Location

Geisinger Health

Wilkes-Barre, Pennsylvania, 18765, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Baylor Scott & White

Temple, Texas, 76508, United States

Location

Related Publications (3)

• Oyeyemi DM, Greene EJ, Xu Y, Lee DR, Samper-Ternent R, Lichtenstein ML, Stevens A, Williamson JD, Karlamangla AS, Saliba D, Reuben DB. Self-efficacy change among diverse family caregivers in dementia care. J Gerontol B Psychol Sci Soc Sci. 2026 Jan 12;81(2):gbaf233. doi: 10.1093/geronb/gbaf233.

  PMID: 41243731 DERIVED

• 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 Oct 1;185(10):1227-1236. doi: 10.1001/jamainternmed.2025.4247.

  PMID: 40892399 DERIVED

• 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.

  PMID: 39878968 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Jenny Summapund
• Organization: University of California Los Angeles

jsummapund@mednet.ucla.edu

3233660667

Study Officials

• David Reuben, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Thomas Gill, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• David Bass, PhD

  Benjamin Rose Institute on Aging

  PRINCIPAL INVESTIGATOR

• Lee Jennings, MD

  University of Oklohoma

  PRINCIPAL INVESTIGATOR

• Maya Lichtenstein, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

• Peter Peduzzi, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Alan Stevens, PhD

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

• Elena Volpi, MD, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

• Jeffrey Williamson, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Christopher Callahan, MD

  Indiana University

  STUDY CHAIR

• Katie Maslow, MSW

  Gerontological Society of America

  STUDY CHAIR

• Jenny Summapund, MA

  University of California, Los Angeles

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Multicampus Program in Geriatric Medicine & Gerontology; Chief, Division of Geriatrics

Model Details: * 2150 dyads of persons with dementia and their respective primary caregiver * 1000 in each intervention arm, and 150 in the usual care arm

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 26, 2018
• Study Start: June 28, 2019
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)