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

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ClinicalTrials.gov Identifier: NCT03786471
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
National Institute on Aging (NIA)
Yale University
Benjamin Rose Institute on Aging
Baylor Scott and White Health
Wake Forest University Health Sciences
University of Texas
Geisinger Clinic
University of Oklahoma
RAND
Information provided by (Responsible Party):
David B. Reuben, MD, University of California, Los Angeles

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, 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 or disease Intervention/treatment Phase
Dementia Other: Health System-based Dementia Care Other: Community-based Dementia Care Other: Enhanced Usual Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2150 participants
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
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive 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
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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.
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

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 to 5 (best)] 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 3, 6, 12 and 18 months.

  7. 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].

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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).

  15. Physician Assessment of Dementia Care at 3 Months [ Time Frame: 3 months ]
    The level of physician satisfaction with dementia care programs as measured by the Physician Assessment of Dementia Care (PADC). The PADC is an 8-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 3 months.

  16. Physician Assessment of Dementia Care at 12 Months [ Time Frame: 12 months ]
    The level of physician satisfaction with dementia care programs as measured by the Physician Assessment of Dementia Care (PADC). The PADC is an 8-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 12 months.

  17. 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 8-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.

  18. 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 and 12 months, and data from the Center for Medicare and Medicaid Services at 18 months.

  19. Cognition of Persons with Dementia [ Time Frame: 18 months ]
    Cognition as measured by the Montreal Cognitive Assessment (MoCA). MoCA is a validated widely used 30-point test (ranging from 0 to 30 with higher scores indicating higher levels of cognition) of cognition that captures mild cognitive impairment as well as dementia. This will be collected at baseline in person and the end of study (by telephone) to document disease progression.

  20. Spouse Caregiver 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 CMS.

  21. Spouse Caregiver 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.

  22. Spouse Caregiver 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.

  23. Spouse Caregiver 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.

  24. Spouse Caregiver 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.

  25. Spouse Caregiver Utilization of Preventive Services [ Time Frame: 18 months ]
    Use of sex and age appropriate Medicare-covered preventive services. This outcome will be attained using data from CMS.

  26. Spouse Caregiver Utilization of Annual Wellness Visit [ Time Frame: 18 months ]
    Use of Medicare-covered Annual Wellness Visit. This outcome will be attained using data from CMS.

  27. Dementia Burden (Caregiver) [ Time Frame: 18 months ]
    Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the NPI-Q Distress, MCSI, and PHQ-9 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.

  28. 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 < 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 < 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.

  29. 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 55 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786471


Contacts
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Contact: Glen Moulton, MPH MA(Ed) 1-310-312-0531 gmoulton@mednet.ucla.edu
Contact: David Reuben, MD

Locations
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United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27109
Contact: Katherine Currie    844-476-8156    DCARE_UM@wakehealth.edu   
Contact    (336) 716-1716      
Principal Investigator: Jeffrey Williamson         
United States, Pennsylvania
Geisinger Health Not yet recruiting
Wilkes-Barre, Pennsylvania, United States, 18765
Contact: Ilene Ladd    570-808-7215      
Principal Investigator: Maya Lichtenstein, MD         
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Roxy Hirst, MS, CCRP    409-266-9641    rmhirst@utmb.edu   
Principal Investigator: Elena Volpi, MD         
Baylor Scott & White Recruiting
Temple, Texas, United States, 76508
Contact: Sitara Abraham    254-771-4836    BSWHDCARE@bswhealth.org   
Principal Investigator: Alan Stevens, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Patient-Centered Outcomes Research Institute
National Institute on Aging (NIA)
Yale University
Benjamin Rose Institute on Aging
Baylor Scott and White Health
Wake Forest University Health Sciences
University of Texas
Geisinger Clinic
University of Oklahoma
RAND
Investigators
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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: Maya Lichtenstein, MD Geisinger Clinic
Principal Investigator: Peter Peduzzi, MD Yale University
Principal Investigator: Alan Stevens, PhD Baylor Scott and White Health
Principal Investigator: Elena Volpi, MD University of Texas
Principal Investigator: Jeffrey Williamson, MD Wake Forest University Health Sciences
Study Chair: Christopher Callahan Indiana University
Study Chair: Katie Maslow Gerontological Society of America
Study Director: Glen Moulton University of California, Los Angeles

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Responsible Party: David B. Reuben, MD, Director, Multicampus Program in Geriatric Medicine & Gerontology; Chief, Division of Geriatrics, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03786471     History of Changes
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) )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David B. Reuben, MD, University of California, Los Angeles:
dementia
pragmatic clinical trial
effectiveness
cost-effectiveness
Alzheimer's disease

Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases