- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03786471
D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care (D-CARE)
Comparative Effectiveness of Health System-based Versus Community-Based Dementia Care / A Pragmatic Clinical Trial of the Effectiveness and Cost-Effectiveness of Dementia Care
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27109
- Wake Forest Baptist Medical Center
-
-
Pennsylvania
-
Wilkes-Barre, Pennsylvania, United States, 18765
- Geisinger Health
-
-
Texas
-
Galveston, Texas, United States, 77555
- University of Texas Medical Branch
-
Temple, Texas, United States, 76508
- Baylor Scott & White
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Active comparator
|
Other: 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.
|
Control
|
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, 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.
|
Active comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of Dementia-related Behavioral Symptoms
Time Frame: 18 months
|
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 outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
|
18 months
|
Caregiver Distress
Time Frame: 18 months
|
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 outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
Time Frame: 18 months
|
Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress).
The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms.
NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress.
The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
|
18 months
|
Severity of Depression in Caregivers
Time Frame: 18 months
|
The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8).
PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores >10 indicating moderate symptoms and scores >20 indicating severe depressive symptoms.
The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
|
18 months
|
Caregiver Self-Efficacy: 4-item self-efficacy scale
Time Frame: 18 months
|
Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale [range, 1 (strongly disagree) to 5 (strongly agree)] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources.
The outcome will be a least squares marginal mean based on follow-up measurements at 6 and 18 months.
The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy.
|
18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life of People with Dementia: QOL-AD
Time Frame: 18 months
|
Quality of life as measured by the Quality of Life in Alzheimer's Disease (QOL-AD).
The QOL-AD is a 13-item instrument scored 4-52 (higher scores indicate better quality of life) that can be administered to persons with dementia and caregivers.
It has demonstrated sensitivity to psychosocial intervention correlates with health-utility measures, is widely translated and used internationally and can be used by people with Mini-Mental State Exam (MMSE) scores as low as three.
The outcome will be measured at 18 months.
|
18 months
|
Cost-Effectiveness Relative to Severity of Dementia-related Behavioral Symptoms
Time Frame: 18 months
|
The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the NPI-Q-Severity.
Thus, the ratio will be the net costs per unit change in NPI-Q-Severity.
Costs will be taken from the perspective of Medicare.
The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about.
The intervention costs, primarily labor, will be collected at the sites.
|
18 months
|
Cost-Effectiveness Relative to Caregiver Distress
Time Frame: 18 months
|
The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the Modified Caregiver Strain Index (MCSI).
Thus, the ratio will be the net costs per unit change in MCSI.
Costs will be taken from the perspective of Medicare.
The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about.
The intervention costs, primarily labor, will be collected at the sites.
|
18 months
|
Functional Status measured by FAQ
Time Frame: 18 months
|
Functional status measured using the Functional Activities Questionnaire (FAQ).
FAQ ranges from 0 to 30 with higher scores indicating more functional dependence.
The outcome will be measured at 18 months.
|
18 months
|
Functional Status measured by ADLs
Time Frame: 18 months
|
Functional status measured using Katz' Index of Independence in Activities of Daily Living (ADL) ranges from 0 to 6 with higher scores indicating more functional independence.
The outcome will be measured at 18 months.
|
18 months
|
Goal Attainment
Time Frame: 18 months
|
Asks patients & caregivers to select their most important goal and assesses their progress towards meeting it as a result of one of the study's intervention.
Goal attainment, defined as whether a person's individual goals are achieved as a result of the study intervention, will be measured using a 5-point goal attainment scale (GAS).
GAS describes the person's expected level of goal achievement over a specified timeframe, ranging from much worse than expected (scored as -2) to much better than expected (scored as +2).
Scales are dynamically set according to a person's needs, while measurement of attainment is standardized.
The outcome will be a least squares marginal mean based on follow-up measurements at 6 and 18 months.
|
18 months
|
Time Spent at Home
Time Frame: 18 months
|
Time spent at home is defined as [number of days since randomization - (number of inpatient days spent at an acute care hospital, inpatient rehabilitation facility, skill nursing facility, long-term care facility, or inpatient hospice unit)/Number of days since randomization].
|
18 months
|
Inpatient Days Spent at an Acute Care Hospital
Time Frame: 18 months
|
Inpatient Days Spent at an Acute Care Hospital is defined as the number of days an individual is admitted to an acute care hospital.
This outcome will be attained using data from the Centers for Medicare and Medicaid Services (CMS).
|
18 months
|
Inpatient Days Spent at an Inpatient Rehabilitation Facility
Time Frame: 18 months
|
Inpatient Days Spent at an Inpatient Rehabilitation Facility is defined as the number of days an individual is admitted to an inpatient rehabilitation facility.
This outcome will be attained using data from CMS.
|
18 months
|
Inpatient Days Spent at a Skilled Nursing Facility
Time Frame: 18 months
|
Inpatient Days Spent at a Skilled Nursing Facility is defined as the number of days an individual is admitted to a Skilled Nursing Facility.
This outcome will be attained using data from CMS.
|
18 months
|
Inpatient Days Spent at a Long-term Care Facility
Time Frame: 18 months
|
Inpatient Days Spent at a Long-term Care Facility is defined as the number of days an individual is admitted to a Long-term Care Facility.
This outcome will be attained using data from CMS.
|
18 months
|
Days Spent Receiving Hospice Benefit
Time Frame: 18 months
|
Days Spent Receiving Hospice Benefit is defined as the number of days an individual is receiving hospice care regardless of location.
This outcome will be attained using data from CMS.
|
18 months
|
Caregiver Assessment of Dementia Care
Time Frame: 18 months
|
Caregiver's satisfaction with the dementia care program is measured using a 11-item questionnaire, modified from the University of California Los Angeles' Alzheimer's and Dementia Care program, with ranges from 11 to 55 (higher scores indicate greater caregiver satisfaction with the dementia care program).
The questionnaire will be administered at 3, 12 and 18 months.
|
18 months
|
Caregiver Rating of Dementia Care Quality
Time Frame: 12 months
|
Caregiver Rating of Dementia Care Quality is a composite instrument of 10 items (with yes or no responses) from the Assessing Care of Vulnerable Elders (ACOVE), Physician Consortium for Performance Improvement (PCPI) and the American Academy of Neurology (AAN) quality measures.
The outcome is a count of the number of yes responses (range 0-10, higher counts indicate greater caregiver rating of satisfaction of dementia care quality).
|
12 months
|
Physician Assessment of Dementia Care at 18 Months
Time Frame: 18 months
|
The level of physician satisfaction with dementia care programs as measured by the Physician Assessment of Dementia Care (PADC).
The PADC is an 5-item questionnaire modified from UCLA's Alzheimer's and Dementia Care program.
Each item will be examined individually (with the range of each item differing).
The questionnaire will be administered at 18 months, when the provider's first enrolled patient completes the study.
All providers with at least one enrolled patient in the study will be surveyed.
|
18 months
|
Cognition of Persons with Dementia
Time Frame: 18 months
|
Cognition as measured by the Montreal Cognitive Assessment (MoCA). MoCA is a validated widely used test of cognition that captures mild cognitive impairment as well as dementia. This will be collected at baseline by telephone and at the end of the study to document disease progression. To reduce respondent burden and missing data, we will use a shortened 3-item form (a 0-12 point scale for evaluating memory, verbal fluency, and orientation only) for reporting study participant baseline characteristics and measuring the decline in cognition. Participants who score 8 or higher on the shortened version will receive the full 22-item telephone MOCA to determine whether they have capacity to provide informed consent. |
18 months
|
Dementia Burden (Caregiver)
Time Frame: 18 months
|
Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the NPI-Q Distress, MCSI, and PHQ-8 scales with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores indicating higher caregiver burden.
The minimal clinically important difference (MCID) for the DBS-CG is 5 points.
The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
|
18 months
|
Positive Aspects of Family Caregiving
Time Frame: 6 months
|
The positive aspects of family caregiving as measured by the Positive Aspects of Family Caregiving Questionnaire, which is an 11-item tool to assess favorable aspects of caregiving experiences, and is scored from 0 to 44 (most positive) with higher scores indicating a more positive mental and affective state related to the caregiver's experience.
The outcome will be measured at 6 months.
|
6 months
|
Number of Persons with Dementia that Die Over the Course of the Study
Time Frame: 18 months
|
Mortality of persons with dementia as measured by interviews with caregivers at 3, 6, 12, and 18 months.
Data will be verified using the Center for Medicare and Medicaid Services at 18 months.
For participants who did not complete the 18-month interview, vital status will be investigated using the electronic health records (EHR).
|
18 months
|
Clinical Benefit
Time Frame: 18 months
|
Clinical benefit is a binary measure of patient symptoms using the NPI-Q severity scale (the only patient outcome anticipated to benefit from the program) and caregiver symptoms using the DBS-CG scale.
Benefit on the NPI-Q severity scale is defined as having a 1-year score of less than or equal to 6 (the lowest tertile of symptoms) or improving by at least 3 points, the MCID.
DBS-CG benefit is defined as having a 1-year score of less than or equal to 18.8 (the lowest tertile of symptoms) or improving by at least 5 points, the MCID.
Defining benefit in this manner captures both preventive (those who have few symptoms at baseline and do not deteriorate) and therapeutic (those who improve) benefit from the program.
The outcome will be an overall odds ratio based on follow-up measurements at 3, 6, 12 and 18 months.
|
18 months
|
Placement in Long-term Care Facility
Time Frame: 18 months
|
Placement in a Long-term Care Facility is defined by (1) observed placement in a long-term care facility, or (2) the time (days) from enrollment to when individual is admitted to a Long-term Care Facility.
This outcome will be attained using data from CMS.
|
18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: 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: Alan Stevens, PhD, Baylor Scott and White Health
- Principal Investigator: Jeffrey Williamson, MD, Wake Forest University Health Sciences
- Principal Investigator: Maya Lichtenstein, MD, Geisinger Clinic
- Principal Investigator: Peter Peduzzi, PhD, Yale University
- Principal Investigator: Elena Volpi, MD, PhD, The University of Texas Health Science Center at San Antonio
- Study Chair: Christopher Callahan, MD, Indiana University
- Study Chair: Katie Maslow, MSW, Gerontological Society of America
- Study Director: Jenny Summapund, MA, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 18-001796
- R01AG061078-01 (U.S. NIH Grant/Contract)
- PCS-2017C1-6534 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on Health System-based Dementia Care
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
-
German Center for Neurodegenerative Diseases (DZNE)University Medicine GreifswaldActive, not recruiting
-
Menorah ParkNational Institute of Mental Health (NIMH)Completed
-
Massachusetts General HospitalNot yet recruitingCognitive Impairment | Dementia | Alzheimer Disease | Dementia With Behavioral DisturbanceUnited States
-
VA Greater Los Angeles Healthcare SystemUniversity of California, Los AngelesUnknown
-
HealthPartners InstituteActive, not recruitingDementiaUnited States
-
German Center for Neurodegenerative Diseases (DZNE)University of Siegen; Gesundheitsregion Siegerland eG (GRS); Alzheimer Gesellschaft... and other collaboratorsRecruitingDementia | Mild Cognitive Impairment | Dementia Alzheimers | Care ManagementGermany
-
RANDNational Institute on Aging (NIA); Alzheimer's Association; Olive View-UCLA Education...CompletedDementiaUnited States
-
Harvard Pilgrim Health CareNational Institute on Aging (NIA); Tufts Health PlanActive, not recruitingAlzheimer's Disease and Related Dementias (ADRD)United States
-
VU University of AmsterdamZorggroep SolisCompleted