New York University School of Medicine
New York, 10016, United States
NCT Number: NCT03255967
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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Notify Me65 year and older
All sexes
Interventional
Not applicable
New York, 10016, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multi-modal quality improvement program for improving the quality of care provided to person with dementia (PWD)-informal caregiver dyads through HHC
Subjects receive care through usual home healthcare assignment process.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Up to Day 60
Measured through interviews with the informal caregiver using the Resource Utilization Inventory.
Time frame: Up to Day 60
Measured through interviews with the informal caregiver using the Resource Utilization Inventory.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Up to Day 60
Measured via patient medication record.
Time frame: Up to Day 60
Measured via patient medication record.
Time frame: Up to Day 60
Time frame: Up to Day 60
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
Time frame: Baseline, Day 60
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.
NYU Langone Health
Other
A Multisite Cluster RCT of the Dementia Symptom Management at Home Program
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