A Multisite Cluster RCT of the Dementia Symptom Management at Home Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Change in Quality of Life-Alzheimer's Disease Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Change in Quality of Life-Alzheimer's Disease Score
时间窗: 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
时间窗: 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.
Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale
时间窗: 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
时间窗: 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 - Family Interaction Scale
时间窗: 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 - Personal Time Scale
时间窗: 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 - Demands of Caregiving Scale
时间窗: 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 - Benefits of Caregiving Scale
时间窗: 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 - Worry Scale
时间窗: 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
时间窗: 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 - Caregiver Feelings Scale
时间窗: 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
时间窗: Up to Day 60
Measured through interviews with the informal caregiver using the Resource Utilization Inventory.
Number of PWD Inpatient Admissions During Study Period
时间窗: Up to Day 60
Measured through interviews with the informal caregiver using the Resource Utilization Inventory.
次要结局
- Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score(Baseline, Day 60)
- Change in Pain Assessment In Advanced Dementia (PAINAD) Score(Baseline, Day 60)
- Number of PWD Who Use Analgesics 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)
- Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers(Baseline, Day 60)
- Number of PWD Who Use Antipsychotics During Study Period(Up to Day 60)
- Number of PWD Outpatient Visits During Study Period(Up to Day 60)
- Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers(Baseline, Day 60)
- Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers(Baseline, Day 60)