Clinical trial NCT03786471: D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care
Official title: Comparative Effectiveness of Health System-based Versus Community-Based Dementia Care / A Pragmatic Clinical Trial of the Effectiveness and Cost-Effectiveness of Dementia Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
pragmatic clinical trial
effectiveness
cost-effectiveness
Alzheimer's disease
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: National Institute on Aging (NIA)
name: Yale University
name: Benjamin Rose Institute on Aging
name: Baylor Scott and White Health
name: Wake Forest University Health Sciences
name: University of Texas
name: Geisinger Clinic
name: University of Oklahoma
name: RAND
First posted: 2018-12-26
Enrollment: 2176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity of Dementia-related Behavioral Symptoms
timeFrame: Baseline
measure: Severity of Dementia-related Behavioral Symptoms
timeFrame: 3-month
measure: Severity of Dementia-related Behavioral Symptoms
timeFrame: 6-month
measure: Severity of Dementia-related Behavioral Symptoms
timeFrame: 12-month
measure: Severity of Dementia-related Behavioral Symptoms
timeFrame: 18-month
measure: Severity of Dementia-related Behavioral Symptoms (Common Baseline)
timeFrame: Baseline
measure: Severity of Dementia-related Behavioral Symptoms
timeFrame: Average of 3M, 6M, 12M, and 18M least square means.
measure: Caregiver Distress/Strain
timeFrame: Baseline
measure: Caregiver Distress/Strain
timeFrame: 3-month
measure: Caregiver Distress/Strain
timeFrame: 6-month
measure: Caregiver Distress/Strain
timeFrame: 12-month
measure: Caregiver Distress/Strain
timeFrame: 18-month
measure: Caregiver Distress/Strain (Common Baseline)
timeFrame: Baseline
measure: Caregiver Distress/Strain
timeFrame: Average of 3M, 6M, 12M, and 18M least square means
Secondary outcomes:
measure: Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
timeFrame: Baseline
measure: Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
timeFrame: 3-month
measure: Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
timeFrame: 6-month
measure: Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
timeFrame: 12-month
measure: Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
timeFrame: 18-month
measure: Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms (Common Baseline)
timeFrame: Baseline
measure: Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
timeFrame: Average of 3M, 6M, 12M, and 18M least square means
measure: Severity of Depression in Caregivers
timeFrame: Baseline
measure: Severity of Depression in Caregivers
timeFrame: 3-month
measure: Severity of Depression in Caregivers
timeFrame: 6-month
measure: Severity of Depression in Caregivers
timeFrame: 12-month
measure: Severity of Depression in Caregivers
timeFrame: 18-month
measure: Severity of Depression in Caregivers (Common Baseline)
timeFrame: Baseline
measure: Severity of Depression in Caregivers
timeFrame: Average of 3M, 6M, 12M, and 18M least square means
measure: Caregiver Self-Efficacy: 4-item Self-efficacy Scale
timeFrame: Baseline
measure: Caregiver Self-Efficacy: 4-item Self-efficacy Scale
timeFrame: 6-month
measure: Caregiver Self-Efficacy: 4-item Self-efficacy Scale
timeFrame: 18-month
measure: Caregiver Self-Efficacy: 4-item Self-efficacy Scale (Common Baseline)
timeFrame: Baseline
measure: Caregiver Self-Efficacy: 4-item Self-efficacy Scale
timeFrame: Average of 6M and 18M least square means
Other outcomes:
measure: Cognition of Persons Living With Dementia
timeFrame: Baseline
measure: Cognition of Persons Living With Dementia (Missing Data)
timeFrame: Baseline
measure: Functional Status Measured by FAQ
timeFrame: Baseline
measure: Functional Status Measured by ADLs
timeFrame: Baseline
measure: Goal Attainment
timeFrame: 18 months
measure: Number of Persons With Dementia That Die Over the Course of the Study
timeFrame: 18 months
measure: Time Spent at Home
timeFrame: 18 months
measure: Caregiver Rating of Dementia Care Quality
timeFrame: 12 months
measure: Caregiver Assessment of Dementia Care
timeFrame: 18 months
measure: Dementia Burden (Caregiver)
timeFrame: 18 months
measure: Clinical Benefit
timeFrame: 18 months
measure: Quality of Life of People With Dementia: QOL-AD
timeFrame: 18 months
measure: Positive Aspects of Family Caregiving
timeFrame: 6 months
measure: Inpatient Days Spent at an Acute Care Hospital
timeFrame: 18 months
measure: Inpatient Days Spent at an Inpatient Rehabilitation Facility
timeFrame: 18 months
measure: Inpatient Days Spent at a Skilled Nursing Facility
timeFrame: 18 months
measure: Inpatient Days Spent at a Long-term Care Facility
timeFrame: 18 months
measure: Placement in Long-term Care Facility
timeFrame: 18 months
measure: Days Spent Receiving Hospice Benefit
timeFrame: 18 months
measure: Physician Assessment of Dementia Care at 18 Months
timeFrame: 18 months
measure: Cost-Effectiveness Relative to Severity of Dementia-related Behavioral Symptoms
timeFrame: 18 months
measure: Cost-Effectiveness Relative to Caregiver Distress
timeFrame: 18 months
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Wilkes-Barre
country: United States
facility: Geisinger Health
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White
state: Texas
Study officials:
affiliation: University of California, Los Angeles
name: David Reuben, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Thomas Gill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benjamin Rose Institute on Aging
name: David Bass, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklohoma
name: Lee Jennings, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Geisinger Clinic
name: Maya Lichtenstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Peter Peduzzi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor Scott and White Health
name: Alan Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Elena Volpi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Jeffrey Williamson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Christopher Callahan, MD
role: STUDY_CHAIR
affiliation: Gerontological Society of America
name: Katie Maslow, MSW
role: STUDY_CHAIR
affiliation: University of California, Los Angeles
name: Jenny Summapund, MA
role: STUDY_DIRECTOR
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