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

Dementia Clinical Trial

— D-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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03786471
• Other study ID #: IRB 18-001796
• Secondary ID: R01AG061078-01PC
• Status: Completed
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: August 21, 2023

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2176
• Est. completion date: August 21, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Health System-based Dementia Care
Active comparator
• Community-based Dementia Care
Active comparator
• Usual Care
Control

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas
United States	Baylor Scott & White	Temple	Texas
United States	Geisinger Health	Wilkes-Barre	Pennsylvania
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (11)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognition of Persons with Dementia	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
Other	Functional Status measured by FAQ	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
Other	Functional Status measured by ADLs	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
Other	Goal Attainment	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
Other	Number of Persons with Dementia that Die Over the Course of the Study	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
Other	Time Spent at Home	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
Other	Caregiver Rating of Dementia Care Quality	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
Other	Caregiver Assessment of Dementia Care	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
Other	Dementia Burden (Caregiver)	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
Other	Clinical Benefit	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
Other	Quality of Life of People with Dementia: QOL-AD	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
Other	Positive Aspects of Family Caregiving	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
Other	Inpatient Days Spent at an Acute Care Hospital	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
Other	Inpatient Days Spent at an Inpatient Rehabilitation Facility	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
Other	Inpatient Days Spent at a Skilled Nursing Facility	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
Other	Inpatient Days Spent at a Long-term Care Facility	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
Other	Placement in Long-term Care Facility	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
Other	Days Spent Receiving Hospice Benefit	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
Other	Physician Assessment of Dementia Care at 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
Other	Cost-Effectiveness Relative to Severity of Dementia-related Behavioral Symptoms	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
Other	Cost-Effectiveness Relative to Caregiver Distress	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
Primary	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 outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.	18 months
Primary	Caregiver Distress	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	Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	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
Secondary	Severity of Depression in Caregivers	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
Secondary	Caregiver Self-Efficacy: 4-item self-efficacy scale	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