An Innovative Supportive Care Model for Dementia and Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Caregiver Reactions to the Behavioral Symptoms of Dementia: Revised Memory and Behavior Problem Checklist (RMBPC)
研究概览
简要总结
There are an increasing number of people in the U.S. with Alzheimer's disease and other dementias. Traumatic brain injuries (TBIs) are also common among both civilians and military personnel, and TBIs increase a person's risk for dementia. Providing care for a person with dementia is stressful. Dementia caregivers can experience difficulties including stress, depression, and reduced quality of life. Coordinated dementia care is known to benefit people with dementia and their caregivers. However, many caregivers do not have access to these supportive programs.
Our project studies the benefits of telehealth as a new way for caregivers to receive coordinated dementia care services. We will offer 75 caregivers a 12-month caregiver support program delivered using telehealth (for example phones, tablets, computers). Caregivers of both Alzheimer's disease and TBI-related dementia will be included, and the program will be evaluated for effectiveness in both groups as well as in a control group. The information from our study will help improve quality of life for caregivers and individuals with dementia, including military members and Veterans. Our results will also help both civilian and military health professionals develop effective programs to support families living with dementia. Policy makers and organizational leaders can use the information to fund programs that best help families and communities facing dementia and TBI dementia.
详细描述
More than 150,000 Virginians live with dementia. Most persons with dementia (PWD) are cared for by an unpaid family caregiver. These caregivers' provision of daily assistance to PWD is a critical part of the state's dementia care capabilities. Caregivers of PWD experience an array of negative biopsychosocial impacts related to their caregiving responsibilities that undermine their own well-being and their care capacity. They are often unprepared to manage the behavioral symptoms of dementia (BSD); unmanaged symptoms are associated with increased use of emergency care and institutional placement, which are burdensome outcomes for PWD, families, and public health systems.
An emergent body of research associates traumatic brain injury (TBI) with increased dementia risk. Veterans with a history of TBI are therefore at increased risk of developing dementia, putting their family members at risk for the established negative impacts of caregiving. Coordinated care programs have proven beneficial for both members of the dementia caregiving dyad, yet access barriers remain. Many caregivers have competing role responsibilities that conflict with consistent dementia care access, others are located in rural areas without access to specialized dementia care.
To surmount access barriers and countervail the negative impacts of caregiving, we propose an innovative, non-pharmacological intervention: a telehealth-delivered dementia care coordination program that provides family and caregiver support and will improve the quality of life (QoL) for both caregivers and PWD. A goal of our project is to fill an existing service gap by providing coordinated dementia care to an underserved population: caregivers of persons with TBI dementia.
Our study will test three primary hypotheses: 1) Caregivers of persons with dementia who participate in the telehealth care coordination program will experience greater improvements in study caregiver outcomes (depression, burden, reactions to BSD and QoL) than caregivers of PWD receiving best medical treatment (BMT); 2) Caregivers who participate in the program will experience greater satisfaction with care than caregivers in the BMT group; 3) The program will comparable benefits for caregivers of persons with Alzheimer's disease and related dementia (PWD-ADRD) and persons with TBI dementia (PWD-TBI).
In addition, our study includes three exploratory hypotheses: 1) Certain caregiver characteristics (external locus of control; lower self-efficacy, sense of hope, and self-perceived caregiver aptitude) will be negatively associated with improvements in caregiver study outcomes; 2) Caregivers in the intervention group will experience greater reductions in emergency/unnecessary health care utilization then caregivers in the BMT group; 3) The intervention will impart sustained caregiver benefits in primary study outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years of age
- •Self-identified primary caregiver for a community-dwelling patient with dementia (PWD)
- •Must be an unpaid caregiver
- •Basic spoken and written English language skills
排除标准
- •Unwilling or unable to fulfill the requirements of the study
- •Any condition which would make the caregiver, in the opinion of the investigator, unsuitable for the study
- •No access to high-speed/broadband internet service capable of operating study teleconferencing software available
- •Patient with Dementia Inclusion Criteria:
- •aged 55 years or older
- •Diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD)
- •Mild to moderate dementia, including mixed dementia
- •0-1 appointments in the multi-disciplinary long-term University of Virginia (UVA) Memory Disorder follow-up clinic (MDC)
- •Patient with Dementia and TBI Inclusion Criteria:
- •aged 21 years or older
- •Diagnosis of major neurocognitive disorder (MND), mild neurocognitive disorder, or Alzheimer's disease and related dementias (ADRD)
- •Diagnosis of mild to moderate dementia, including mixed dementia
- •Diagnosed with mild complicated, moderate or sever traumatic brain injury (TBI)
- •TBI event at or after the age of brain maturity, ≥25 years of age
- •No exclusion criteria for patients with dementia and/or traumatic brain injury.
结局指标
主要结局
Caregiver Reactions to the Behavioral Symptoms of Dementia: Revised Memory and Behavior Problem Checklist (RMBPC)
时间窗: Change outcome measure at Baseline and 12 months and 18 months
The RMBPC is a 24-item, caregiver-reported measure that assesses the frequency of problematic behaviors in patients with dementia and the severity of caregivers' reactions to these behaviors. The reliability and validity of the RMBPC have been established.
Depression: Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
时间窗: Change outcome measure at Baseline and 12 months and 18 months
The CESD-R assesses self-reported symptoms of depression. The revised version was developed to reflect current understanding of psychiatric depressive symptoms. The revised 20-item version is highly correlated with the original CESD, demonstrating test validity.
Satisfaction with Care: Caregiver Satisfaction Survey (CSS)
时间窗: Change outcome measure at 12 months and 18 months
The CSS is an investigator-developed survey that assesses satisfaction with care services.
Caregiver Burden: Zarit Burden Interview (ZBI)
时间窗: Change outcome measure at Baseline and 12 months and 18 months
The ZBI is a 22-item caregiver self-report measure assessing degree of caregiver burden in caregivers of PWD. The validated ZBI questions include measures of caregivers' health, finances, social supports, and psychological well-being.
Quality of Life: WHO (Five) Well-Being Index (WHO-5)
时间窗: Change outcome measure at Baseline and 12 months and 18 months
The WHO-5 contains five questions that measure well-being; scores range from 0-25, with higher scores representing higher QoL. The WHO-5 is a validated tool that has been used successfully as an outcome measure in clinical trials across a wide range of study fields.
次要结局
- Self-Efficacy: General Self-Efficacy scale (GSE).(Baseline, 12 months)
- Neuropsychiatric Symptoms and Caregiver Reactions: Neuropsychiatric Inventory Questionnaire (NPI-Q).(Baseline, 12 months)
- Optimism/Pessimism: Life-Orientation Test-Revised (LOT-R)(Baseline, 12 months)
- Quality of Life in PWD: Quality of Life in Alzheimer's Disease (QoL-AD).(Baseline, 12 months)
- Anxiety: Geriatric Anxiety Inventory (GAI).(Baseline, 12 months)
- Dementia Knowledge: Dementia Knowledge Assessment Tool Version 2 (DKAT2).(Baseline, 12 months)
- Preparedness for Caregiving: Preparedness for Caregiving Scale (PCS).(Baseline, 12 months)
- Healthcare Resource Utilization: Resource Utilization in Dementia, (RUD) questionnaire version 4.0.(Baseline, 12 months)
- Instrumental Activities of Daily Living: Lawton Instrumental Activities of Daily Living Scale (Lawton).(Baseline, 12 months)
- Basic Activities of Daily Living: Katz Index of Independence in Activities of Daily Living (Katz).(Baseline, 12 months)
研究者
Carol Manning
Harrison Distinguished Teaching Professor of Neurology, Vice Chair for Faculty Development, Director Memory Disorders Clinic
University of Virginia