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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)

Primary Purpose

Dementia

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Health System-based Dementia Care

Community-based Dementia Care

Usual Care

About this trial

This is an interventional supportive care trial for Dementia focused on measuring dementia, pragmatic clinical trial, effectiveness, cost-effectiveness, Alzheimer's disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wake Forest Baptist Medical Center
Geisinger Health
University of Texas Medical Branch
Baylor Scott & White

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Arm Label

Health Systems-Based Dementia Care

Community-Based Dementia Care

Usual Care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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 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.

Full Information

NCT ID

NCT03786471

First Posted

December 17, 2018

Last Updated

March 23, 2023

Sponsor

University of California, Los Angeles

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

1. Study Identification

Unique Protocol Identification Number

NCT03786471

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 28, 2019 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Health Systems-Based Dementia Care

Arm Type

Active Comparator

Arm Description

Arm Title

Community-Based Dementia Care

Arm Type

Active Comparator

Arm Description

Arm Title

Usual Care

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Health System-based Dementia Care

Intervention Description

Active comparator

Intervention Type

Other

Intervention Name(s)

Community-based Dementia Care

Intervention Description

Active comparator

Intervention Type

Other

Intervention Name(s)

Usual Care

Intervention Description

Control

Primary Outcome Measure Information:

Title

Severity of Dementia-related Behavioral Symptoms

Description

Time Frame

18 months

Title

Caregiver Distress

Description

Time Frame

18 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

18 months

Title

Severity of Depression in Caregivers

Description

Time Frame

18 months

Title

Caregiver Self-Efficacy: 4-item self-efficacy scale

Description

Time Frame

18 months

Other Pre-specified Outcome Measures:

Title

Quality of Life of People with Dementia: QOL-AD

Description

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.

Time Frame

18 months

Title

Cost-Effectiveness Relative to Severity of Dementia-related Behavioral Symptoms

Description

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.

Time Frame

18 months

Title

Cost-Effectiveness Relative to Caregiver Distress

Description

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.

Time Frame

18 months

Title

Functional Status measured by FAQ

Description

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.

Time Frame

18 months

Title

Functional Status measured by ADLs

Description

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.

Time Frame

18 months

Title

Goal Attainment

Description

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.

Time Frame

18 months

Title

Time Spent at Home

Description

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].

Time Frame

18 months

Title

Inpatient Days Spent at an Acute Care Hospital

Description

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).

Time Frame

18 months

Title

Inpatient Days Spent at an Inpatient Rehabilitation Facility

Description

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.

Time Frame

18 months

Title

Inpatient Days Spent at a Skilled Nursing Facility

Description

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.

Time Frame

18 months

Title

Inpatient Days Spent at a Long-term Care Facility

Description

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.

Time Frame

18 months

Title

Days Spent Receiving Hospice Benefit

Description

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.

Time Frame

18 months

Title

Caregiver Assessment of Dementia Care

Description

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.

Time Frame

18 months

Title

Caregiver Rating of Dementia Care Quality

Description

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).

Time Frame

12 months

Title

Physician Assessment of Dementia Care at 18 Months

Description

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.

Time Frame

18 months

Title

Number of Persons with Dementia that Die Over the Course of the Study

Description

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.

Time Frame

18 months

Title

Cognition of Persons with Dementia

Description

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.

Time Frame

18 months

Title

Spouse Caregiver Inpatient Days Spent at an Acute Care Hospital

Description

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.

Time Frame

18 months

Title

Spouse Caregiver Inpatient Days Spent at an Inpatient Rehabilitation Facility

Description

Time Frame

18 months

Title

Spouse Caregiver Inpatient Days Spent at a Skilled Nursing Facility

Description

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.

Time Frame

18 months

Title

Spouse Caregiver Inpatient Days Spent at a Long-term Care Facility

Description

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.

Time Frame

18 months

Title

Spouse Caregiver Days Spent Receiving Hospice Benefit

Description

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.

Time Frame

18 months

Title

Spouse Caregiver Utilization of Preventive Services

Description

Use of sex and age appropriate Medicare-covered preventive services. This outcome will be attained using data from CMS.

Time Frame

18 months

Title

Spouse Caregiver Utilization of Annual Wellness Visit

Description

Use of Medicare-covered Annual Wellness Visit. This outcome will be attained using data from CMS.

Time Frame

18 months

Title

Dementia Burden (Caregiver)

Description

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.

Time Frame

18 months

Title

Clinical Benefit

Description

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.

Time Frame

18 months

Title

Positive Aspects of Family Caregiving

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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.

Overall Study Officials: