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Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our public health. While many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare, most home healthcare clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. This study will therefore utilize a cluster randomized controlled design at 3 study sites to examine the ability of a multi-component evidence-based practice primary palliative care quality improvement program for home healthcare registered nurses, occupational therapists and physical therapists to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QI program care | Experimental | DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program |
|
| Control | Active Comparator | Receive usual care from a care team who has not received the performance improvement program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSM-H | Behavioral | Multi-modal quality improvement program for improving the quality of care provided to person with dementia (PWD)-informal caregiver dyads through HHC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life-Alzheimer's Disease Score | 13-item measurement of Alzheimer's disease patients' health-related quality of life (HRQOL) by proxy (caregiver) assessment. Each item is rated on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period. | Baseline, Day 60 |
| Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the IADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with IADLs improved during the observational period. | Baseline, Day 60 |
| Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the ADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with ADLs improved during the observational period. | Baseline, Day 60 |
| Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Assessment In Advanced Dementia (PAINAD) Score | 5-item assessment of pain in individuals with advanced dementia. Items are ranked on a 3-point Likert scale from 0 to 2. The total score is the sum of responses and ranges from 0 (no pain) to 10 (severe pain). An increase in scores indicates pain increased during the observational period. | Baseline, Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abraham Brody, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32320844 | Derived | Bristol AA, Convery KA, Sotelo V, Schneider CE, Lin SY, Fletcher J, Rupper R, Galvin JE, Brody AA. Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers. Contemp Clin Trials. 2020 Jun;93:106005. doi: 10.1016/j.cct.2020.106005. Epub 2020 Apr 19. |
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The trial enrolled 215 Patient-Caregiver Dyads (215 patients with dementia (PWD) and 215 caregivers). 119 Dyads were randomized to the QI program care arm and 96 Dyads were randomized to the Control arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | QI Program Care | DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program DSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC |
| FG001 | Control | receive usual care from a care team who has not received the performance improvement program Standard of Care: Subjects receive care through usual home healthcare assignment process. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | QI Program Care - PWD | Patients with dementia (PWD) assigned to the QI program care arm as part of a Patient-Caregiver dyad. |
| BG001 | QI Program Care - Caregiver | Caregivers assigned to the QI program care arm as part of a Patient-Caregiver dyad. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Quality of Life-Alzheimer's Disease Score | 13-item measurement of Alzheimer's disease patients' health-related quality of life (HRQOL) by proxy (caregiver) assessment. Each item is rated on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
|
60 Days
The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.
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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 | QI Program Care - PWD | Patients with dementia (PWD) assigned to the QI program care arm as part of a Patient-Caregiver dyad. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in symptoms of dementia | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abraham Brody | NYU Langone Health | 2129927341 | Abraham.Brody@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2021 | Mar 31, 2023 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Behavioral | Subjects receive care through usual home healthcare assignment process. |
|
The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the role limitations scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to role limitation due to caregiving improved during the observational period. |
| Baseline, Day 60 |
| Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the personal time scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to personal care improved during the observational period. | Baseline, Day 60 |
| Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the family interaction scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to family interaction improved during the observational period. | Baseline, Day 60 |
| Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the demands of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to demands of caregiving improved during the observational period. | Baseline, Day 60 |
| Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the worry scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to worry improved during the observational period. | Baseline, Day 60 |
| Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the spirituality scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to spirituality improved during the observational period. | Baseline, Day 60 |
| Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the benefits of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to benefits of caregiving improved during the observational period. | Baseline, Day 60 |
| Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the caregiver feelings scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to caregiver feelings improved during the observational period. | Baseline, Day 60 |
| Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period | Measured through interviews with the informal caregiver using the Resource Utilization Inventory. | Up to Day 60 |
| Number of PWD Inpatient Admissions During Study Period | Measured through interviews with the informal caregiver using the Resource Utilization Inventory. | Up to Day 60 |
| Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score | 13-item tool that measures caregiver perceptions of Behavioral and Psychological Symptoms of Dementia (BPSD). For each item, The severity of the reported symptoms is assessed on a 3-point scale. The total severity score ranges from 0 to 36 with higher scores representing worse severity. An increase in score indicates severity of BPSD increased during the observational period. | Baseline, Day 60 |
| Number of PWD Who Use Antipsychotics During Study Period | Measured via patient medication record. | Up to Day 60 |
| Number of PWD Who Use Analgesics During Study Period | Measured via patient medication record. | Up to Day 60 |
| Number of PWD Outpatient Visits During Study Period | Up to Day 60 |
| Number of PWD Primary Care Provider Contacts During Study Period | Up to Day 60 |
| Change in Zarit Burden Inventory Score Among Caregivers | 22-item self-assessment of burden experienced by caregivers. Items are ranked on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 88, where: 0 - 21 = little or no burden; 21 - 40 = mild to moderate burden; 41 - 60 = moderate to severe burden; and 61 - 88 = severe burden. An increase in scores indicates burden increased during the observational period. | Baseline, Day 60 |
| Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers | 9-item measurement of depression in which caregivers indicate how often they have been bothered by specific problems over the previous 2 weeks. Items are ranked on 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater severity of depression. | Baseline, Day 60 |
| Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers | 12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). Physical Composite Scores (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline, Day 60 |
| Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers | 12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). Mental Health Composite Scores (MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline, Day 60 |
| Schedule conflict |
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| POA did not sign consent form |
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| BG002 | Control - PWD | Patients with dementia (PWD) assigned to the control arm as part of a Patient-Caregiver dyad. |
| BG003 | Control - Caregiver | Caregivers assigned to the control arm as part of a Patient-Caregiver dyad. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG001 |
| Control |
receive usual care from a care team who has not received the performance improvement program Standard of Care: Subjects receive care through usual home healthcare assignment process. |
|
|
| Primary | Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the IADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with IADLs improved during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
|
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|
| Primary | Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the ADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with ADLs improved during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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|
| Primary | Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the role limitations scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to role limitation due to caregiving improved during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Primary | Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the personal time scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to personal care improved during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Primary | Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the family interaction scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to family interaction improved during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Primary | Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the demands of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to demands of caregiving improved during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Primary | Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the worry scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to worry improved during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Primary | Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the spirituality scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to spirituality improved during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Primary | Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the benefits of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to benefits of caregiving improved during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Primary | Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the caregiver feelings scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to caregiver feelings improved during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Primary | Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period | Measured through interviews with the informal caregiver using the Resource Utilization Inventory. | Posted | Mean | Standard Deviation | ER visits | Up to Day 60 |
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| Primary | Number of PWD Inpatient Admissions During Study Period | Measured through interviews with the informal caregiver using the Resource Utilization Inventory. | Posted | Mean | Standard Deviation | Hospitalizations | Up to Day 60 |
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| Secondary | Change in Pain Assessment In Advanced Dementia (PAINAD) Score | 5-item assessment of pain in individuals with advanced dementia. Items are ranked on a 3-point Likert scale from 0 to 2. The total score is the sum of responses and ranges from 0 (no pain) to 10 (severe pain). An increase in scores indicates pain increased during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Secondary | Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score | 13-item tool that measures caregiver perceptions of Behavioral and Psychological Symptoms of Dementia (BPSD). For each item, The severity of the reported symptoms is assessed on a 3-point scale. The total severity score ranges from 0 to 36 with higher scores representing worse severity. An increase in score indicates severity of BPSD increased during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Secondary | Number of PWD Who Use Antipsychotics During Study Period | Measured via patient medication record. | Posted | Count of Participants | Participants | Up to Day 60 |
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| Secondary | Number of PWD Who Use Analgesics During Study Period | Measured via patient medication record. | Posted | Count of Participants | Participants | Up to Day 60 |
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| Secondary | Number of PWD Outpatient Visits During Study Period | Posted | Mean | Standard Deviation | Outpatient Visits | Up to Day 60 |
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| Secondary | Number of PWD Primary Care Provider Contacts During Study Period | Posted | Mean | Standard Deviation | Primary Care Provider Contacts | Up to Day 60 |
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| Secondary | Change in Zarit Burden Inventory Score Among Caregivers | 22-item self-assessment of burden experienced by caregivers. Items are ranked on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 88, where: 0 - 21 = little or no burden; 21 - 40 = mild to moderate burden; 41 - 60 = moderate to severe burden; and 61 - 88 = severe burden. An increase in scores indicates burden increased during the observational period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Secondary | Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers | 9-item measurement of depression in which caregivers indicate how often they have been bothered by specific problems over the previous 2 weeks. Items are ranked on 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater severity of depression. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| Secondary | Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers | 12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). Physical Composite Scores (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
|
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| Secondary | Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers | 12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). Mental Health Composite Scores (MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 60 |
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| 6 |
| 119 |
| 26 |
| 119 |
| 21 |
| 119 |
| EG001 | QI Program Care - Caregiver | Caregivers assigned to the QI program care arm as part of a Patient-Caregiver dyad. | 0 | 119 | 3 | 119 | 5 | 119 |
| EG002 | Control - PWD | Patients with dementia (PWD) assigned to the control arm as part of a Patient-Caregiver dyad. | 10 | 96 | 34 | 96 | 9 | 96 |
| EG003 | Control - Caregiver | Caregivers assigned to the control arm as part of a Patient-Caregiver dyad. | 0 | 96 | 4 | 96 | 1 | 96 |
| Caregiver severe depression (Increase Score on PHQ-9 [Day 60]) | Psychiatric disorders | Systematic Assessment |
|
| Caregiver suicide idealization | Psychiatric disorders | Systematic Assessment |
|
| Death related | General disorders | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Change in pre-existing condition | General disorders | Systematic Assessment |
|
| New Diagnosis | General disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Depressive Symptoms (Score on PHQ-9) | Psychiatric disorders | Systematic Assessment |
|
| Injury not life threatening | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Delirium False Positive | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001523 | Mental Disorders |