Dementia
Conditions
Brief summary
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.
Interventions
BEHAVIORALDSM-H
Multi-modal quality improvement program for improving the quality of care provided to person with dementia (PWD)-informal caregiver dyads through HHC
BEHAVIORALStandard of Care
Subjects receive care through usual home healthcare assignment process.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PWD over the age of 65 * Admitted to one of the three HHC agencies * The patient and family caregiver speak English and/or Spanish. * The informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient. * Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment).
Exclusion criteria
* Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety. * PWD residing in assisted living facilities or board and care homes * PWD solely receiving infusion or home health aide services.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of PWD Inpatient Admissions During Study Period | Up to Day 60 | Measured through interviews with the informal caregiver using the Resource Utilization Inventory. |
| Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale | 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. |
| Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale | 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. |
| Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale | 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. |
| Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale | 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. |
| Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale | 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. |
| Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale | 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. |
| Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale | 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. |
| Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale | 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. |
| Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale | 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. |
| Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period | Up to Day 60 | Measured through interviews with the informal caregiver using the Resource Utilization Inventory. |
| Change in Quality of Life-Alzheimer's Disease Score | 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. |
| Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score | 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. |
| Number of PWD Who Use Antipsychotics During Study Period | Up to Day 60 | Measured via patient medication record. |
| Number of PWD Who Use Analgesics During Study Period | Up to Day 60 | Measured via patient medication record. |
| 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 | 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. |
| Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers | 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. |
| Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers | 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. |
| Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers | 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. |
| Change in Pain Assessment In Advanced Dementia (PAINAD) Score | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| QI Program Care - PWD Patients with dementia (PWD) assigned to the QI program care arm as part of a Patient-Caregiver dyad. | 119 |
| QI Program Care - Caregiver Caregivers assigned to the QI program care arm as part of a Patient-Caregiver dyad. | 119 |
| Control - PWD Patients with dementia (PWD) assigned to the control arm as part of a Patient-Caregiver dyad. | 96 |
| Control - Caregiver Caregivers assigned to the control arm as part of a Patient-Caregiver dyad. | 96 |
| Total | 430 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 26 | 30 |
| Overall Study | POA did not sign consent form | 2 | 0 |
| Overall Study | Schedule conflict | 6 | 4 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | QI Program Care - PWD | Total | Control - Caregiver | Control - PWD | QI Program Care - Caregiver |
|---|---|---|---|---|---|
| Age, Continuous | 83 years STANDARD_DEVIATION 7.3 | 71.75 years STANDARD_DEVIATION 7.6 | 57 years STANDARD_DEVIATION 11.9 | 84 years STANDARD_DEVIATION 7.9 | 63 years STANDARD_DEVIATION 13.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 55 Participants | 12 Participants | 12 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 375 Participants | 84 Participants | 84 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 2 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 124 Participants | 27 Participants | 27 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 8 Participants | 2 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 19 Participants | 3 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 74 Participants | 271 Participants | 62 Participants | 62 Participants | 73 Participants |
| Region of Enrollment United States | 119 participants | 430 participants | 96 participants | 96 participants | 119 participants |
| Sex: Female, Male Female | 74 Participants | 302 Participants | 73 Participants | 63 Participants | 92 Participants |
| Sex: Female, Male Male | 45 Participants | 128 Participants | 23 Participants | 33 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 119 | 0 / 119 | 10 / 96 | 0 / 96 |
| other Total, other adverse events | 21 / 119 | 5 / 119 | 9 / 96 | 1 / 96 |
| serious Total, serious adverse events | 26 / 119 | 3 / 119 | 34 / 96 | 4 / 96 |
Outcome results
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale | 47.45 score on a scale | Standard Deviation 37.45 |
| Control | Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale | 44.94 score on a scale | Standard Deviation 37.26 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale | 81.38 score on a scale | Standard Deviation 20.18 |
| Control | Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale | 79.34 score on a scale | Standard Deviation 20.64 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale | 72.53 score on a scale | Standard Deviation 16.82 |
| Control | Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale | 76.49 score on a scale | Standard Deviation 13.73 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale | 56.6 score on a scale | Standard Deviation 24.39 |
| Control | Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale | 56.22 score on a scale | Standard Deviation 25.35 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale | 53.27 score on a scale | Standard Deviation 28.45 |
| Control | Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale | 52.11 score on a scale | Standard Deviation 28.42 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale | 12.32 score on a scale | Standard Deviation 16.69 |
| Control | Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale | 15.88 score on a scale | Standard Deviation 22.77 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale | 38.71 score on a scale | Standard Deviation 22.12 |
| Control | Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale | 40.34 score on a scale | Standard Deviation 19.67 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale | 46.33 score on a scale | Standard Deviation 28.96 |
| Control | Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale | 46.56 score on a scale | Standard Deviation 26.76 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale | 79.25 score on a scale | Standard Deviation 29.1 |
| Control | Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale | 67.75 score on a scale | Standard Deviation 33.94 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale | 51.25 score on a scale | Standard Deviation 21.7 |
| Control | Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale | 52.56 score on a scale | Standard Deviation 19.89 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Quality of Life-Alzheimer's Disease Score | 12.32 score on a scale | Standard Deviation 16.69 |
| Control | Change in Quality of Life-Alzheimer's Disease Score | 15.88 score on a scale | Standard Deviation 22.77 |
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.
Time frame: Up to Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period | 0.08 ER visits | Standard Deviation 0.34 |
| Control | Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period | 0.08 ER visits | Standard Deviation 0.31 |
Primary
Number of PWD Inpatient Admissions During Study Period
Measured through interviews with the informal caregiver using the Resource Utilization Inventory.
Time frame: Up to Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Number of PWD Inpatient Admissions During Study Period | 0.08 Hospitalizations | Standard Deviation 0.4 |
| Control | Number of PWD Inpatient Admissions During Study Period | 0.13 Hospitalizations | Standard Deviation 0.38 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score | 8.45 score on a scale | Standard Deviation 6.31 |
| Control | Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score | 7.96 score on a scale | Standard Deviation 5.78 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Pain Assessment In Advanced Dementia (PAINAD) Score | 0.14 score on a scale | Standard Deviation 0.62 |
| Control | Change in Pain Assessment In Advanced Dementia (PAINAD) Score | 0.05 score on a scale | Standard Deviation 0.28 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers | 4.8 score on a scale | Standard Deviation 5.03 |
| Control | Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers | 4.27 score on a scale | Standard Deviation 4.04 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers | 46.63 score on a scale | Standard Deviation 11.8 |
| Control | Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers | 47.59 score on a scale | Standard Deviation 9.26 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers | 47.15 score on a scale | Standard Deviation 11.13 |
| Control | Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers | 47.13 score on a scale | Standard Deviation 11.36 |
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.
Time frame: Baseline, Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Change in Zarit Burden Inventory Score Among Caregivers | 29.65 score on a scale | Standard Deviation 16.21 |
| Control | Change in Zarit Burden Inventory Score Among Caregivers | 26.14 score on a scale | Standard Deviation 13.45 |
Secondary
Number of PWD Outpatient Visits During Study Period
Time frame: Up to Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Number of PWD Outpatient Visits During Study Period | 4.5 Outpatient Visits | Standard Deviation 12.15 |
| Control | Number of PWD Outpatient Visits During Study Period | 3.16 Outpatient Visits | Standard Deviation 4.02 |
Secondary
Number of PWD Primary Care Provider Contacts During Study Period
Time frame: Up to Day 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QI Program Care | Number of PWD Primary Care Provider Contacts During Study Period | 0.64 Primary Care Provider Contacts | Standard Deviation 0.86 |
| Control | Number of PWD Primary Care Provider Contacts During Study Period | 0.68 Primary Care Provider Contacts | Standard Deviation 0.84 |
Secondary
Number of PWD Who Use Analgesics During Study Period
Measured via patient medication record.
Time frame: Up to Day 60
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QI Program Care | Number of PWD Who Use Analgesics During Study Period | 45 Participants |
| Control | Number of PWD Who Use Analgesics During Study Period | 39 Participants |
Secondary
Number of PWD Who Use Antipsychotics During Study Period
Measured via patient medication record.
Time frame: Up to Day 60
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QI Program Care | Number of PWD Who Use Antipsychotics During Study Period | 20 Participants |
| Control | Number of PWD Who Use Antipsychotics During Study Period | 11 Participants |