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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC4AG038804-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Olive View-UCLA Education & Research Institute | OTHER |
| Alzheimer's Association | OTHER |
| National Institute on Aging (NIA) | NIH |
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Dementia is a condition that is growing in prevalence and which harms not only the afflicted individual but also adversely affects the health of their family and other informal caregivers. New methods for delivering comprehensive assistance to persons with dementia and their caregivers are known to be effective and can delay nursing home placement, but this study will discover 1) whether more face-to-face involvement rather than telephone delivery of this assistance will work better among poor patients in Los Angeles, and 2) if one method is better than the other, what are the differences in costs between them. These data will enable administrators in public health care settings around the US and non-profit foundations addressing dementia patient and caregiver needs to decide what method provides the best value and the best outcome relative to its cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dementia care management in person | Active Comparator | The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone. |
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| Dementia care management telephone only | Active Comparator | The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dementia care management | Behavioral | Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems. An electronic tracking tool and resource manual guide delivery of the care management protocols. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiver Burden at 6 and 12 Months | The Zarit Burden Interview (BI) is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia. Originally a 29-item instrument, the 22-item modified version is easily completed by telephone. This instrument covers five constructs of burden: health, psychological well-being, finances, social life, and relationship with impaired person and an overall summary score of caregiver burden. Higher Zarit scores indicate greater caregiver burden. The minimum possible score is 0, and the maximum possible score is 110. | 0, 6 and 12 months |
| Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months | The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues. The RMBPC instrument assess 24 care receiver problems in the areas of behavior, memory, and depression and whether each behavior had occurred in the prior week. Higher RMBPC scores mean worse memory/behavior problems. The minimum possible score for number of problems is zero, and the maximum score for number of problems is 24. | 0, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiver Depression at 6 and 12 Months | The Patient Health Questionnaire - Nine (PHQ-9) is a 9-item self-report measure of depressive symptoms over the previous 2 weeks. The PHQ-9 is the depression module of the PRIME- MD diagnostic instrument for common mental disorders. It covers each of the 9 DSM-IV depression criteria scoring them as "0" (not at all) to "3" (nearly every day). | 0, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Chodosh, M.D., MSHS | RAND | Principal Investigator |
| Barbara Vickrey, M.D., MPH | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olive View-UCLA Medical Center | Sylmar | California | 91342-1495 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25656074 | Result | Chodosh J, Colaiaco BA, Connor KI, Cope DW, Liu H, Ganz DA, Richman MJ, Cherry DL, Blank JM, Carbone Rdel P, Wolf SM, Vickrey BG. Dementia Care Management in an Underserved Community: The Comparative Effectiveness of Two Different Approaches. J Aging Health. 2015 Aug;27(5):864-93. doi: 10.1177/0898264315569454. Epub 2015 Feb 4. |
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A research assistant (RA) got informed consent either in-person at clinic or by phone for outreach/admin data sources. Contact info was sent to the survey group who completed enrollment and a baseline survey; then participants were randomized by the RA. Between the survey and randomization, 3 CGs were found ineligible and 4 duplicates were found.
Adult caregivers (CG) lived with dementia care recipient (CR) or were the main support for >6 months. CRs had to live in the community (no nursing home). Admin data (ICD-9 codes) yielded eligible CRs from Olive View Med Center+local clinics. CRs got recruitment mailings to give to CG. CG were also recruited at CR's memory clinic+community outreach
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| ID | Title | Description |
|---|---|---|
| FG000 | Dementia Care Management in Person | The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone. Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems. |
| FG001 | Dementia Care Management Telephone Only | The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person. Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 6 Months |
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| |||||||||||||||||||||
| 6 Months to 12 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dementia Care Management in Person | The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone. Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This is the caregiver age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Caregiver Burden at 6 and 12 Months | The Zarit Burden Interview (BI) is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia. Originally a 29-item instrument, the 22-item modified version is easily completed by telephone. This instrument covers five constructs of burden: health, psychological well-being, finances, social life, and relationship with impaired person and an overall summary score of caregiver burden. Higher Zarit scores indicate greater caregiver burden. The minimum possible score is 0, and the maximum possible score is 110. | Posted | Mean | Standard Deviation | units on a scale | 0, 6 and 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dementia Care Management in Person | The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone. Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Chodosh or Barbara Vickrey | University of California Los Angeles | 310-206-7671 | jchodosh@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
| Change in Caregiver Quality of Life at 6 and 12 Months | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish. Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. | 0, 6 and 12 months |
| Change in Care Recipient Quality of Life at 6 and 12 Months | The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population. The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers. | 0, 6 and 12 months |
| Change in Process Measures of Dementia Care Quality at 6 and 12 Months | The investigators will collect caregiver survey identified care process measures to assess which medical care processes that are specific to dementia occurred as a potential mediator of change in outcomes. | 0, 6 and 12 months |
| Lost to Follow-up |
|
| NOT COMPLETED |
|
|
| BG001 | Dementia Care Management Telephone Only | The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person. Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | This is the caregiver's gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | This is the caregiver's race/ethnicity | Number | participants |
|
| Education | This is the caregiver's educational attainment | Number | participants |
|
| Language spoken with friends and family | This is the caregiver's language spoken with friends and family | Number | participants |
|
| Relationship type to care recipient | This is the caregiver's relationship to the care recipient/person with dementia. | Number | participants |
|
| OG001 | Dementia Care Management Telephone Only | The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person. Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up. |
|
|
|
| Primary | Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months | The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues. The RMBPC instrument assess 24 care receiver problems in the areas of behavior, memory, and depression and whether each behavior had occurred in the prior week. Higher RMBPC scores mean worse memory/behavior problems. The minimum possible score for number of problems is zero, and the maximum score for number of problems is 24. | Posted | Mean | Standard Deviation | units on a scale | 0, 6 and 12 months |
|
|
|
|
| Secondary | Change in Caregiver Depression at 6 and 12 Months | The Patient Health Questionnaire - Nine (PHQ-9) is a 9-item self-report measure of depressive symptoms over the previous 2 weeks. The PHQ-9 is the depression module of the PRIME- MD diagnostic instrument for common mental disorders. It covers each of the 9 DSM-IV depression criteria scoring them as "0" (not at all) to "3" (nearly every day). | Not Posted | 0, 6 and 12 months |
| Secondary | Change in Caregiver Quality of Life at 6 and 12 Months | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish. Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. | Not Posted | 0, 6 and 12 months |
| Secondary | Change in Care Recipient Quality of Life at 6 and 12 Months | The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population. The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers. | Not Posted | 0, 6 and 12 months |
| Secondary | Change in Process Measures of Dementia Care Quality at 6 and 12 Months | The investigators will collect caregiver survey identified care process measures to assess which medical care processes that are specific to dementia occurred as a potential mediator of change in outcomes. | Not Posted | 0, 6 and 12 months |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Dementia Care Management Telephone Only | The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person. Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up. | 0 | 73 | 0 | 73 |
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| D001523 | Mental Disorders |
| Baseline score |
|
| 3.55 |
The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse problems for the in-person arm compared to the phone arm. |
| No |
| Superiority or Other |